Clinical research in China is regulated and overseen by the National Medical Products Administration (NMPA) (the Chinese name translates as “State Drug Administration”) and the National Health Commission (NHC).

National Medical Products Administration

As per the DRR, the NMPA-Org, the DAL, the RegImplemDAL, the RegImplemDAL-Amndt, the SC-Opinions-No44, the NMPA-No50-2018, and the NMPA-No230-2015, the NMPA is the regulatory authority responsible for national drug registration management, which includes regulation of clinical trials. Per the DRR, NMPA’s Center for Drug Evaluation (CDE) is responsible for the evaluation of drug clinical trial applications, drug marketing authorization applications, supplementary applications, and overseas drug production registration applications. The NMPA grants permission for clinical trials to be conducted in China in accordance with the provisions of the DAL, the VaccineLaw, the DRR, the SC-Opinions-No44, the NMPA-No50-2018, and the NMPA-No230-2015. The drug category in which an applicant chooses to register determines the clinical trial application review and approval or filing process.

Per the SC-IRP and the SAMR-Org, China established the State Administration for Market Regulation (SAMR). The SAMR is a full ministry agency reporting directly to the State Council of the People's Republic of China. Under the SAMR is the NMPA, which regulates clinical trials.

As delineated in the NMPA-Org and CHN-78, the NMPA implements China’s guidelines, policies, and decision-making for the supervision and administration of drugs, medical devices, and cosmetics. It is responsible for safety supervision; standards management; drug registration; quality management; risk management; pharmacist licensing; inspection systems; international cooperation; guiding provincial and municipal drug administration; and other tasks assigned by the State Council and Party Central Committee. The NMPA is charged with accelerating the examination and approval of innovative drugs, establishing a system of listing license holders, promoting electronic review and approval, and improving efficiencies.

Per CHN-77, the following NMPA departments are involved with clinical trial application and drug registration:

• Drug Registration Management Department – formulates, supervises, and implements drug standards (including clinical trial quality management), technical guidelines, and registration
• Drug Administration Department – formulates and supervises the implementation of pharmaceutical production quality management standards for drugs, Chinese medicines, biological products, and special drugs (e.g., radioactive and toxic), and formulates and implements a drug adverse reaction monitoring and alert system

Per the DRR, the NMPA-No50-2018, and CHN-81, the NMPA includes the National Institutes for Food and Drug Control (NIFDC) and the CDE, which are directly involved in the clinical trial application and drug registration approval process. Other relevant institutes and organizations include the National Pharmacopoeia Commission, the Food and Drug Inspection Center, the Medical Device Technology Evaluation Center, the Administration Service Center, the Information Center, the Licensed Pharmacist Certification Center, the News and Publicity Center, and the International Exchange Center.

Further, the DRR delineates the responsibilities of the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government. With respect to clinical trials, they are responsible for organizing the daily supervision and investigation of institutions conducting drug clinical trials; participating in drug registration verification and inspection organized by the NMPA; and other matters entrusted by the NMPA.

The roles of the CDE and the NIFDC in the clinical trial application review and approval process are discussed further in the Scope of Assessment section.

National Health Commission

Per the NHC-HGRmgt, the State Council’s NHC is responsible for China’s management of human genetic resources (HGR). (Note that per SC-Order777 and NHC-HGRmgt, management of HGR was transferred from the Ministry of Science and Technology (MOST) to NHC, effective May 1, 2024). The NHC-HGRmgt states that the original application process and online platform (CHN-6) remain unchanged. As indicated in CHN-24, the NHC is responsible for formulating health policies and systems in China, including health services, hospitals, special populations, drugs, traditional Chinese medicines, and disease control and prevention. See CHN-24 for a comprehensive list of NHC responsibilities and functions. (Please note that the MgmtHumanGen was amended by SC-Order777 to reflect the transfer of HGR management from MOST to the NHC, but the Rules-MgmtHGR has not been amended yet to show the transfer.)

The MgmtHumanGen and the Rules-MgmtHGR stipulate that MOST’s (now the NHC’s) HGR responsibilities include employing experts in the fields of biotechnology, medicine, health, ethics, law, etc. to form an expert review committee to review and approve international cooperative research. The Rules-MgmtHGR indicates that MOST (now the NHC) should support the rational use of HGR to carry out scientific research, develop the biomedical industry, improve diagnosis and treatment techniques, strengthen management and oversight of HGR, improve approval services and efficiency, and advance the standardization of approvals and information disclosure. MOST (now the NHC) is responsible for national efforts such as the investigation, administrative licensing, supervision and inspection, and administrative punishments of HGR. Regarding administrative licensing, licenses must be obtained for the collection and preservation of Chinese HGR and for international collaborations in certain situations. As needed, MOST (now the NHC) entrusts relevant organizations to carry out formal reviews and technical reviews of application materials for administrative licensing of HGR, as well as efforts such as filing, prior reporting, supervision and inspection, and administrative punishments. The science and technology departments (committees and bureaus) of provinces, autonomous regions, and municipalities directly under the Central Government, and the Science and Technology Bureau of the Xinjiang Production and Construction Corps, are responsible for the management of the following HGR in their regions:

• Oversight and inspection and routine management of HGR
• Investigation and handling of illegal cases of HGR within the scope of their authority
• As entrusted by MOST (now the NHC), carry out other efforts such as administrative licensing of HGR in their region

See Rules-MgmtHGR-Interp for a policy interpretation of the Rules-MgmtHGR.

Per HGR-WorkUpdt, the NHC’s China Biotechnology Development Center was entrusted to implement technical work related to the management of HGR. As described in CHN-4, the functions of the Center are:

• Coordinate and supervise the implementation of the management of HGR
• Examine and approve international cooperation projects involving HGR
• Accept applications for the export of HGR, and handle exports and export certificates
• Register and manage important genetic lineages and genetic resources in specific regions
• Manage other work related to HGR

The Rules-MgmtHGR also state that applications must pass a security review organized by MOST (now the NHC) if the study’s provision or opening of HGR information to foreign entities may impact China’s public health, national security, or the social public interest. In addition, per the Bioscrty-Law, MOST (now the NHC) regulates biotechnology safety under the National Security Commission pursuant to a Coordination Mechanism for National Biosecurity (CMNB). The CMNB consists of the competent State Council departments for health, agriculture and rural affairs, science and technology, and foreign affairs, as well as relevant military agencies, to analyze national biosecurity issues, and organize, coordinate, and drive national biosecurity work. MOST (now the NHC) and the other agencies under CMNB establish safety monitoring/reporting requirements, an early warning system, and implementing regulations.

Regarding monitoring and protecting HGR, as delineated in MgmtHumanGen, NHC (formerly the MOST) is also authorized to strengthen the protection of HGR in China, which involves conducting surveys and implementing a declaration and registration system for important genetic families and human genetic resources in specific regions. MOST (now the NHC) will enforce the regulations and levy fines for illegal HGR activities which include:

• Collecting HGR from important genetic families and specific regions in China without approval, or collecting HGR of the types and quantities specified by MOST (now the NHC) through special regulation
• Preserving Chinese HGR without approval
• Conducting international cooperative scientific research using Chinese HGR without approval
• Failing to pass the security review that may affect China's public health, national security, and social public interest to foreign organizations, individuals, and institutions that they establish or actually control, and
• Failing to file with MOST (now the NHC) the type, quantity, and use of the HGR in China before an international cooperative clinical trial begins

Other Considerations

Per CHN-59, China is a regulatory member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). CHN-49 summarizes the ICH guiding principles and provides Chinese translations, when available.

Please note: China is party to the Nagoya Protocol on Access and Benefit-sharing (CHN-30), which may have implications for studies of investigational products developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see CHN-55.

Contact Information

National Medical Products Administration (NMPA)

Per CHN-31, the following is the NMPA’s contact information:

National Medical Products Administration
No. 1 Beiluyuan Zhanlan Road
Xicheng District
Beijing 100037
P.R. China

Per CDE-Reloctn, the following is CDE’s contact information:

National Medical Products Administration
Center for Drug Evaluation
Building 1-5
District 2, No. 22 Guangde Street
Beijing Economic and Technological Development Zone
Beijing, 100076
P.R. China

Phone number: 010-68585566

National Health Commission

Per HGR-WorkUpdt, HGR-AppGuide, and CHN-4, following is the contact information for NHC’s HGR consultation:

National Health Commission
China Biotechnology Development Center
Rooms 1022 and 1001, Building 4
No. 16 West Fourth Ring Middle Road
Haidian District
Beijing, 100036
P.R. China

Contact: Zhu Min
Phone number: 010-88225151 or 010-88225168
Information system support: 17610386080
Email: ycb@cncbd.org.cn

Clinical research in Kenya is regulated and overseen by the Pharmacy and Poisons Board (PPB) and the National Commission for Science, Technology and Innovation (NACOSTI).

Pharmacy and Poisons Board

As per the PPA, the CTRules, and the G-KenyaCT, Kenya’s PPB is the regulatory authority responsible for clinical trial approvals, oversight, and inspections. As described in KEN-21, the PPB and its Expert Committee on Clinical Trials (ECCT) evaluate all matters relating to clinical trials and grant permission for clinical trials to be conducted in Kenya. See KEN-20, KEN-21, and KEN-16 for more information about PPB.

Per the PPA and the CTRules, the PPB is authorized to undertake various mandated duties regarding regulation of medicines including (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

• Advise the government in all matters relating to the safety, packaging, labelling, distribution, and disposal of medicines
• Ensure that all medicinal products manufactured in, imported into, or exported from the country conform to prescribed standards of quality, safety, and efficacy
• Ensure that the personnel, premises, and practices employed in the manufacture, storage, marketing, distribution, and sale of medicinal substances comply with the defined codes of practice and other prescribed requirements
• Grant or revoke licenses for the manufacture, importation, exportation, distribution, and sale of medicinal substances
• Maintain a register of all authorized medicinal substances
• Publish, at least once every three (3) months, lists of authorized or registered medicinal substances and lists of products with marketing authorizations
• Regulate narcotic, psychotropic substances, and precursor chemical substances
• Consider applications for approval and alterations of dossiers intended for use in marketing authorization of medical products and health technologies
• Inspect and license all manufacturing premises, importing and exporting agents, wholesalers, distributors, pharmacies (including those in hospitals and clinics), and other retail outlets
• Prescribe a system for sampling, analysis, and other testing procedures of finished medicinal products released into the market to ensure compliance with the labeled specifications
• Conduct post-marketing surveillance of safety and quality of medical products
• Monitor the market for the presence of illegal or counterfeit medicinal substances
• Regulate the promotion, advertising, and marketing of medicinal substances in accordance with approved product information
• Approve the use of any unregistered medicinal substance for purposes of clinical trials, compassionate use, and emergency use authorization during public health emergencies
• Approve and regulate clinical trials on health products
• Disseminate information on medical products to health professionals and to the public to promote their rational use
• Collaborate with other national, regional, and international institutions on medicinal substances regulation
• Advise the Cabinet Secretary on matters relating to control, authorization, and registration of medicinal substances
• Implement any other function relating to the regulation of medicinal substances

Please note: Kenya is party to the Nagoya Protocol on Access and Benefit-sharing (KEN-3), which may have implications for studies of investigational products developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see KEN-15.

National Commission for Science, Technology and Innovation

As delineated in the STI-Act and G-ECBiomedRes, in addition to obtaining the PPB’s permission to conduct research in Kenya, the principal investigator or the head of a research institution must obtain a favorable opinion from an ethics committee accredited by NACOSTI and a NACOSTI research license prior to initiating a study. NACOSTI’s role is to regulate and ensure quality in the science, technology, and innovation sector, and to advise the Kenyan government on related matters. According to Part II of the STI-Act, NACOSTI has specific research coordination and oversight functions, and it liaises with the National Innovation Agency and the National Research Fund to ensure funding and implementation of prioritized research programs. In addition per the STI-Act and KEN-39, NACOSTI is mandated to register and accredit research institutions in Kenya. The objective of registration and accreditation is to uphold the standard of research in the country and secure public confidence in the national research system. See KEN-32 for more information about NACOSTI’s mandate and functions.

Contact Information

Pharmacy and Poisons Board

According to the G-KenyaCT and KEN-22, the PPB contact information is as follows:

Pharmacy and Poisons Board
P.O. Box 27663 - 00506
Lenana Road Opp. DOD
Nairobi, Kenya

Telephone: (+254) 709 770 100 or (+254) 709 770 xxx (where xxx represents the extension of the officer or office)
Email: info@ppb.go.ke or info@pharmacyboardkenya.org
For Clinical Trials Inquiries: cta@pharmacyboardkenya.org

National Commission for Science, Technology and Innovation

According to KEN-29, the NACOSTI contact information is as follows:

National Commission for Science, Technology and Innovation
off Waiyaki, Upper Kabete
P. O. Box 30623
00100 Nairobi, Kenya

Phone (landline): (+254) 020 4007000, (+254) 020 8001077
Phone (mobile): 0713 788 787 / 0735 404 245

Email: customercare@nacosti.go.ke or info@nacosti.go.ke

Overview

National Medical Products Administration

In accordance with the DRR, the DAL, the NMPA-No50-2018, the SC-Opinions-No44, and the NMPA-No230-2015, the National Medical Products Administration (NMPA) is responsible for reviewing and approving clinical trial applications for drugs to be registered in China, as required. The DRR clarifies that the NMPA regulates clinical trials for drugs in development that are ultimately seeking market approvals in China. Per the DAL and the DRR, and as explained in CHN-7, CHN-18, and CHN-1, China adopted a drug marketing authorization holders (MAHs) system across China. All entities or drug research institutions holding drug marketing authorizations must take responsibility for drug safety, effectiveness, and quality controllability in the whole process of drug research and development, production, distribution, and use. Based on this system, the MAHs are also named as applicants or sponsors during clinical trials. The scope of the NMPA’s assessment includes Phase I through Phase IV clinical trials and bioequivalence studies. As stated in the DRR, clinical trials of drugs must be reviewed and approved by an ethics committee (EC). The DRR indicates that EC review may be submitted in parallel to NMPA’s review, but the study cannot be initiated until after review and approval by the EC. The DRR emphasizes a risk-based approach to drug registration and clinical trial approvals, following the principles of openness, fairness, and justice. This is guided by demonstrating clinical value, encouraging research and creation of new drugs, and promoting the development of generic drugs.

As delineated in the DRR, the SC-Opinions-No44, and the NMPA-No51-2016, the drug classification in which an applicant chooses to register determines the clinical trial application review and approval process. Per the DRR, the registration of drugs must be classified and managed in accordance with three (3) broad categories of Chinese medicines, chemical medicines, and biological products. The NMPA-No44-2020 and CHN-1 delineate the classifications within the chemical medicine category as follows:

• Class 1: Innovative drugs that have not been marketed in China or overseas (i.e., drugs that contain new compounds with clear structures and pharmacological effects, and have clinical values)
• Class 2: Modified new drugs that have not been marketed in China or overseas (i.e., drugs that have their structure, dosage form, formulation, process, route of administration, and indications optimized on the basis of known active ingredients and have significant clinical advantages)
• Class 3: Drugs manufactured by domestic applicants by imitating the original drugs that have been marketed overseas but not yet in China; such drugs must have the quality and efficacy consistent with the reference listed drug
• Class 4: Drugs manufactured by domestic applicants by imitating the original drugs that have been marketed in China; such drugs must have the quality and efficacy consistent with the reference formulations
• Class 5: Drugs that have been marketed overseas and are under application for being marketed in China

As per NMPA-No21-2021, the NMPA provides additional technical support to expedite the review and approval process of domestically unlisted drugs that have been listed overseas in the above Classes 3 and 5.

Per the DRR, the registration of biological products is classified according to innovative biological products, new medicines of improved biological products, and already listed biological products (including biological similar drugs). As delineated in the NMPA-No43-2020, biological products refer to preparations that use microorganisms, cells, animal or human-derived tissues, and bodily fluids as starting materials, and are made with biological technology for the prevention, treatment, and diagnosis of human diseases. In order to standardize the registration and management of biological products, biological products are divided into preventive biological products, therapeutic biological products, and in vitro diagnostic reagents managed by biological products. Preventive biological products refer to vaccine-like biological products used for human immunization to prevent and control the occurrence and prevalence of diseases, including immunization program vaccines and non-immunization program vaccines. Therapeutic biological products refer to biological products used in the treatment of human diseases, such as proteins, polypeptides and their derivatives prepared from engineered cells (such as bacteria, yeast, insect, plant, and mammalian cells) with different expression systems; cell therapy and gene therapy products; allergen products; microecological products; biologically active products extracted from human or animal tissues or bodily fluids or prepared by fermentation, etc. The following are descriptions of biological product classifications for both preventive and therapeutic uses:

• Class 1: Innovative vaccines that have not been marketed at home or abroad
• Class 2: Improved vaccines that improve the safety, effectiveness, and quality controllability of new products by improving the domestic or overseas marketed vaccine products, and have obvious advantages
• Class 3: Vaccines that have been marketed at home or abroad

Per the VaccineLaw, the NMPA must approve vaccine clinical trials. The NMPA-No32-2019 explains that the VaccineLaw strengthens the supervision and enforcement of vaccines and deepens the reform of the drug review and approval system. This includes strengthening the management of vaccine clinical trial institutions and investigating and punishing illegal activities related to applying for vaccine clinical trials (e.g., false data).

National Health Commission

Per the NHC-HGRmgt, the National Health Commission (NHC) is responsible for China’s management of human genetic resources (HGR). (Note that per SC-Order777 and NHC-HGRmgt, management of HGR was transferred from the Ministry of Science and Technology (MOST) to NHC, effective May 1, 2024. SC-Order777 amends the MgmtHumanGen to reflect the transfer of HGR management from MOST to NHC, but the Bioscrty-Law and the Rules-MgmtHGR have not been amended yet to show the transfer). Per the Bioscrty-Law and the MgmtHumanGen, MOST’s (now the NHC’s) scope of assessment is the collection, preservation, utilization, and external provision of HGR to ensure these activities:

• Do not endanger the public health, national security, and social public interests of China
• Are in accordance with ethics principles and reviews per relevant regulations
• Respect the privacy rights of HGR donors, obtain their prior informed consent, and protect their legitimate rights and interests, and
• Comply with the technical norms formulated by MOST (now the NHC)

See the Rules-MgmtHGR for the prescribed conditions when MOST (now the NHC) licenses must be obtained for the collection of Chinese HGR.

As delineated in the Rules-MgmtHGR, MOST (NHC) licenses must be obtained for the preservation of HGR, which involves storing HGR with legal sources under appropriate environmental conditions, ensuring their quality and safety, and using them for future scientific research, excluding temporary storage for teaching purposes. If the preservation also involves the collection of HGR, applicants only need to apply for an administrative license for the preservation of HGR, and do not need to separately apply for a collection license. Next, the Rules-MgmtHGR require administrative licenses for international scientific research cooperation that use and export HGR. If there is no export, only prior filing/notification with MOST (now the NHC) is required before initiating the international research cooperation.

Per the Rules-MgmtHGR, where multicenter clinical research is carried out, the sponsor or the primary site/unit (either the Chinese unit or a foreign party unit) may apply for administrative licensing or filing after the primary site/unit passes the ethics review. After the sponsor or primary site/unit obtains the administrative license or completes the filing, the medical and health institution(s) participating in the clinical research must submit the ethics review approval document of their site/unit, or the certification materials for the ethics review approval provided by the primary site/unit, along with the letter of commitment issued by the site/unit, to MOST (now the NHC). Following those submissions, the international cooperative clinical research can be carried out.

As delineated in the HGR-AppGuide, the scope of the administrative license for the collection of HGR applies to the following activities to be carried out within the territory of China:

• HGR collection activities for important genetic pedigrees – applies to blood-related groups with genetic diseases and/or with special hereditary physical or physiological characteristics, as well as the members of the group with genetic diseases and/or special hereditary physical or physiological characteristics involving three (3) generations or more.
• HGR collection activities in specific areas – applies to HGR from populations who have lived in isolation or special environments for a long time and have special physical characteristics or adaptive traits in physiological characteristics. Specific areas are not divided based on whether they are ethnic minority concentrated areas.
• HGR collection activities for large-scale population research with a population of more than 3,000 – includes but is not limited to cohort studies, cross-sectional studies, clinical studies, and constitutional studies.

Clinical Trial Review Process

National Medical Products Administration

As delineated in the DRR, the NMPA is the regulatory authority responsible for national drug registration management, which includes management of clinical trial applications. The NMPA’s Center for Drug Evaluation (CDE) is responsible for evaluating drug clinical trial applications, drug marketing authorization applications, supplementary applications, and re-registration applications for drugs produced overseas. The DRR states that applicants may communicate with major technical institutions including the CDE at key stages, such as before submitting a drug clinical trial application.

Communications and Pre-Application Protocol Review

Per the NMPA-No50-2018, the NMPA-No48-2020, and the NMPA-No51-2023, with regard to chemical drugs and biological products, the applicant must first request a communication meeting with the CDE to determine the integrity of the clinical trial application data and the feasibility of conducting the clinical trial. The NMPA-No51-2023 reaffirms the required communications between the applicant and the CDE and review of the clinical trial protocol before submitting the clinical trial application. The CDE conducts a preliminary review of the information provided by the applicant according to relevant requirements. The review team reviews the science, completeness, operability, and risk controllability of the clinical trial protocol, focusing on the basis for the research, safety, and whether the risk management measures of the drug support the conduct of clinical trials. In addition to clearly responding to the specific questions raised by the applicant, the submitted clinical trial protocol is reviewed to ensure participant protection. For confirmatory, or critical clinical trials, CDE must also evaluate the suitability of the target population, the science of the dosage and cycle and the primary endpoint indicators, the acceptability of statistical assumptions, the rationality of sample size estimation, the operability of the risk management plan, and the benefit/risk assessment elements. CDE’s review team communicates its findings by holding a meeting (face-to-face or online) or by giving a written reply and must provide the applicant with the minutes of the communication meeting or the written reply. See NMPA-No51-2023 for additional details on the pre-application communications and protocol review.

Clinical Trial Application Review

Per the NMPA-No50-2018, the NMPA’s Drug Registration Management Department is responsible for conducting administrative reviews of clinical trial applications, and then forwarding the submissions to the CDE for technical review. (Deviations from this general process are described further below in this section.) The DRR states that after completing the pharmacology, toxicology, and other studies supporting the clinical trials of the drug, the applicant must submit relevant research materials in accordance with the application requirements (See Submission Process and Submission Content sections for details). If the application materials meet the screening requirements, NMPA’s pharmaceutical, medical, and other technical personnel review the clinical trial applications for drugs.

Per the DRR, when reviewing the application, the CDE will conduct an associated review of the chemical raw materials, auxiliary materials, and packaging materials and containers used in direct contact with the pharmaceutical preparations. The CDE makes a risk-based decision on whether to initiate an on-site inspection based on the registered varieties, processes, facilities, and previous acceptance verification. For innovative drugs, improved new drugs, and biological products, on-site verification of drug registration manufacturing and inspection of pre-market drug manufacturing quality management must be conducted. If manufacturing verification is required, the applicant and the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the applicant or manufacturer is located will be informed. The National Institutes for Food and Drug Control (NIFDC) (also referred to as the Procuratorate), or the drug inspection agency designated by the NMPA, will conduct the inspections and testing, as needed. The drug registration inspection of overseas-produced drugs must be implemented by the port drug inspection agency.

The NMPA-No51-2023 specifies that the CDE review team must evaluate the science, completeness, operability, and risk controllability of the clinical trial protocol in the application. If necessary, an expert consultation meeting may be held. For clinical trials that are approved after review, the technical review team’s conclusion and associated "Clinical Trial Approval Notice" must clearly state the indications, clinical trial protocol title, number, version number, version date, etc. The review team’s conclusion and notice may propose revisions or suggestions to the clinical trial protocol if necessary. For clinical trial protocols that require revisions, CDE will notify the applicant through a professional inquiry letter, clearly informing the applicant of the problems and revision opinions in the current protocol. The applicant must submit a revised clinical trial protocol within five (5) days, following the guidance in the Prcdrs-Changes. For clinical trial protocols that are deemed unfeasible, have participant safety risks, or other serious defects, and the applicant cannot revise and improve them within the time limit specified in the inquiry letter, the clinical trial application will not be approved. In the review team’s conclusion and the "Notice of Disapproval of Drug Clinical Trials", the applicant should be clearly informed of the reasons for the disapproval.

The NMPA-No51-2023 also states that before conducting subsequent phased drug exploratory clinical trials, a corresponding drug clinical trial protocol must be reviewed and approved by the EC. After completing exploratory clinical trials and before conducting confirmatory (or critical) clinical trials, an application for a communication meeting must be submitted to the CDE to evaluate the subsequent clinical trial protocol (if applicable).

With regard to vaccine clinical trials, the VaccineLaw indicates that the NMPA will review the clinical trial plan, the safety monitoring and evaluation system, the selection of participants, and whether there are effective measures according to the degree of risk to protect the legal rights of the participants. Vaccine clinical trials can only be carried out or organized by a tertiary medical institution that meets the conditions prescribed by the NMPA and the health and safety department of the State Council, or a disease prevention and control institution at or above the provincial level.

Per the DRR, the DAL, the NMPA-No50-2018, and CHN-14, a clinical trial application will be considered approved after 60 working days if the applicant does not receive a rejection or an inquiry for clarification from the NMPA. As specified in the DRR, drug clinical trials must be carried out within three (3) years after approval. If the drug clinical trial application is approved and no participant signs an informed consent form within three (3) years from the date of approval, the approval lapses. If it is still necessary to carry out the drug clinical trial, the applicant must re-apply. Upon approval/registration of the drug, the applicant receives a drug registration certificate, which is valid for five (5) years. An application for drug re-registration must be submitted six (6) months before the validity period expires.

The DRR states that to amend content in the original drug registration approval, the applicant must conduct sufficient research and verification on the change of the drug and fully evaluate the possible impact of the change on the drug. Data on the impact of safety, efficacy, and quality control must be submitted with the application for amendment. The NMPA-No51-2023 indicates that when changes to a clinical trial protocol are needed, the sponsor may first conduct a self-assessment of the changes in accordance with the relevant requirements of the DRR and the NMPA-No34-2022, and implement further work based on the results of the self-assessment. For substantial changes, the sponsor must submit materials in accordance with the relevant requirements of the NMPA-No34-2022. The CDE review team must review the supplementary application and notify the applicant of whether any/all of the proposed changes are approved. For changes that are not approved, CDE must clearly state the reasons. See NMPA-No51-2023 for definitions of substantial and non-substantial changes to a protocol. Also see Prcdrs-Changes for working procedures for other changes during the review of the clinical trial application.

Expedited Clinical Trial Review

The DRR authorizes regulatory pathways for priority review and approval (including for breakthrough therapeutic drugs), conditional approval, and special approval procedures. As per the SC-Opinions-No44, the NMPA-No230-2015, and the NMPA-No51-2016, a new drug classification system, priority review for innovative drugs and those deemed to have an urgent clinical need, and other changes help China to be more innovative and expedite reviews. With regard to priority review, per the NMPA-No230-2015 and the DRR, the NMPA may apply expedited review and approval procedures to applications for urgently needed drugs and vaccines that are intended to treat certain illnesses or patient populations (e.g., children or elderly people) that the State Council or the NMPA consider to be clinically in demand. The DRR expanded priority review to breakthrough therapeutic drugs, which are used to prevent and treat diseases with the following conditions: are seriously life threatening or seriously affect the quality of life, there are no effective prevention or treatment methods, and there is sufficient evidence to show that they have obvious clinical advantages. Applicants must apply to the CDE at the critical stage of the drug clinical trial. See CHN-69 for handling guidelines on priority review and approval.

The NMPA-No21-2024 describes NMPA’s pilot work plan for optimizing the review and approval of clinical trials for innovative drugs. This initiative aims to review and approve innovative drug clinical trial applications within 30 business days (a reduction from the 60 days as described above in the normal procedures). Pilot projects will be carried out in provinces (autonomous regions and municipalities) that meet the conditions laid out in NMPA-No21-2024. The scope of the pilot project is clinical trial applications for Class 1 innovative drugs (excluding cell and gene therapy products, vaccine products, etc.). Applicants are not subject to regional restrictions and must have at least three (3) innovative drug clinical trial applications approved at home and abroad, have extensive experience in clinical trial implementation and pharmacovigilance management, and be able to conduct a comprehensive risk assessment of clinical trial projects and develop an effective risk management plan before submitting a clinical trial application. In principle, the pilot institution must be a national medical center or national clinical medical research center in the pilot area and must have established a work system to provide clinical trial project establishment, ethics review, and contract review services before the applicant submits a new drug clinical trial application. See NMPA-No21-2024 for additional requirements on application submission and applicant and institutional eligibility. The applicant must initiate the clinical trial within 12 weeks after the approval of the clinical trial application. The pilot work will last for one (1) year and the experience of the pilot work will be summarized in July 2025. One (1) pilot project has been approved in Beijing and Shanghai as indicated in NMPA-No55-2024.

According to the NMPA-No82-2020, the NMPA establishes working procedures for the review of breakthrough therapy drugs, conditional approval of drug marketing priority review, and approval of drug marketing authorization. Sponsors can apply for expedited status for breakthrough therapeutic drugs in Phase I and II clinical trials—usually no later than before the commencement of Phase III clinical trials. Breakthrough drug procedures are designed to be used during clinical trials of drugs to prevent and treat patients with conditions that may be severely life-threatening or that may severely affect their quality of life. There are also no existing effective prevention and treatment methods nor is there sufficient evidence to show that the investigational drugs being tested have obvious clinical advantages compared with existing treatment methods. Also see CondtlAppl-Drugs for technical guidelines on the conditional approval of drugs for marketing.

Per the NMPA-No79-2018, the NMPA established a special review channel for urgently needed drugs that were already on the market in the United States, Europe, and Japan since 2008. Applicants may apply for a drug listing and proceed to conduct the clinical trials while the CDE conducts a technical review of the application materials.

The DRR also authorizes the CDE to conditionally approve breakthrough therapeutic drugs for marketing during clinical trials and vaccines that are urgently needed for major public health emergencies and the benefits outweigh the risks. The applicant must communicate to the CDE on the conditions for marketing with conditional approval and the research work to be completed after marketing, and submit an application for drug marketing approval after communication and confirmation. For the conditionally approved drugs and vaccines, risk management measures must be implemented after the drug is marketed, and the drug clinical trial must be completed within the prescribed time limit. Finally, the DRR authorizes the NMPA to implement special approval procedures for drugs required for public health emergencies. The circumstances, procedures, time limits, and requirements for special approval, will be subject to the NMPA’s procedures for specific approval of drugs.

For background on China’s reformation of the review and approval system to encourage innovation of drugs, see the SC-Opinions-No42. China’s regulatory pathways for expedited approvals and other reforms to the clinical trial submission and review process are described in the Submission Process and Submission Content sections. NMPA-No52-2018-Interp describes the requirements for clinical trial and drug registration applications using trial data generated entirely overseas, as well as data generated from simultaneous research occurring in China and abroad. CHN-11 also provides useful information on the NMPA’s overall clinical trial application review and approval process.

Overseas Data and Waiving Local Clinical Trials

The NMPA-No35-2017 and interpretations in NMPA-No52-2018-Interp describe requirements for clinical trial and drug registration applications to the NMPA using trial data generated entirely overseas, as well as data generated from simultaneous research occurring in China and abroad. With regard to the latter, researchers can conduct Phase I of multi-regional clinical trials (MRCT) of imported investigational new drugs and therapeutic biological products (excluding vaccines) simultaneously in China.

As per NMPA-No52-2018, clinical trial and drug registration applications for imported new drugs or therapeutic biological products using trial data generated entirely overseas do not need to be registered first in their own country in order to enter China. Overseas clinical trial data is acceptable for direct China registration provided that:

• The data is reliable, authenticated, and complies with the requirements of the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CHN-37)
• The data can assess the efficacy and safety for the target indication
• There are no ethnic sensitivities to Chinese local populations influencing efficacy and safety
• The data meets China’s drug registration requirements

See the NMPA-No52-2018 for additional details on the review and approval of overseas clinical trial data. For overseas clinical trial data completed before the enactment of NMPA-No35-2017, the NMPA will consider exemption from conducting local clinical trials, with the condition that the applications meet all other Chinese drug regulatory requirements.

For a running list (in reverse chronological order) of NMPA guidance on drug regulatory requirements, please refer to CHN-60.

National Health Commission

The MgmtHumanGen and the Bioscrty-Law prohibit foreign entities or individuals from collecting or preserving Chinese HGR in China, or providing Chinese HGR for use abroad, except under prescribed conditions to carry out scientific research activities, which must be conducted through collaboration with Chinese scientific research institutions, higher education institutions, medical institutions, or enterprises. Per the MgmtHumanGen and the Rules-MgmtHGR, the foreign entity and the Chinese entity must jointly file an application for approval to MOST (now the NHC), and the research must pass an ethics review in the countries (regions) where the partners are located. The only exception to the approval requirement is international collaborations in clinical trials that do not involve the export of Chinese HGR materials such as organs, tissues, or cells comprising the human genome, genes, or other genetic substances. Such clinical trial collaborations, however, must be filed with MOST (now the NHC) on its online platform (CHN-6), which will generate a record number. See HGR-InfoSys for background on CHN-6. Per HGR-InfoSys, for help with the online platform, contact Zhu Min with the NHC’s China Biotechnology Development Center at 010-88225151 or 010-88225168; or the information system support at 17610386080.

Per the HGR-AppGuide, following administrative screening, the NHC will confirm receipt through CHN-6 and organize a technical review. NHC must conduct its review and issue a decision within 20 working days. If the application is approved, NHC notifies the applicant of the approval through CHN-6 and a letter. If there are missing materials, NHC gives the applicant a one-time opportunity to correct the application and resubmit. If the application exceeds the scope of the license, NHC informs the applicant that the application is not approved.

The Bioscrty-Law prohibits engaging in biotechnology research, development, and application activities that endanger public health, damage biological resources, or destroy ecosystems and biodiversity. Units engaged in biotechnology clinical trials must be responsible for the safety of their biotechnology research, development, and application; adopt biosafety risk prevention and control measures; and formulate biosafety training, follow-up inspections, regular reports, etc. China is implementing a classified management system for biotechnology research and development activities into three (3) categories: high-risk, medium-risk, and low-risk. The risk classification standards are to be formulated, adjusted, and announced by the competent State Council departments for science and technology (now the NHC), health, agriculture, and rural areas. High-risk and medium-risk biotechnology research and development activities must include risk assessments and risk prevention/control and emergency plans for biosafety incidents. The Rules-MgmtHGR also states that clinical trial applications must pass a security review organized by MOST (now the NHC) if the study’s provision or opening of HGR information to foreign entities may impact China’s public health, national security, or the social public interest.

For additional details, see the HGR-FAQs for frequently asked questions on HGR applications. Also see the Submission Process and Submission Content sections and the Specimens topic for additional information on HGR regulatory management.

Overview

In accordance with the PPA, the CTRules, the G-KenyaCT, and KEN-21, Kenya’s Pharmacy and Poisons Board (PPB), together with its Expert Committee on Clinical Trials (ECCT), is responsible for reviewing, evaluating, and approving applications for clinical trials using registered or unregistered investigational products (IPs). The G-KenyaCT specifies that the scope of the PPB’s assessment includes all clinical trials (Phases I-IV). As delineated in the CTRules, the G-KenyaCT, and KEN-21, the PPB review and approval process may not be conducted in parallel with the ethics committee (EC) review. Rather, EC approval must be obtained prior to applying for PPB approval. As delineated in the STI-Act and G-ECBiomedRes, the principal investigator or the head of a research institution must obtain a favorable opinion from an EC accredited by the National Commission for Science, Technology and Innovation (NACOSTI) and a NACOSTI research license prior to initiating a study.

Clinical Trial Review Process

Pharmacy and Poisons Board

Per the CTRules and the G-KenyaCT, the PPB, through the ECCT, communicates the decision to approve, request additional information, or reject the application to the sponsor or the representative in writing within 30 working days of receiving a valid application. The G-KenyaCT indicates that in the case of rejection, the applicant may appeal and provide additional information to satisfy PPB requirements. In specific cases, the PPB may decide to refer the matter to external experts for recommendation.

As specified in the G-KenyaCT, each ECCT member, prior to reviewing the application, will declare any conflict of interest in the study and should have no financial or personal interests, which could affect their impartiality. During the protocol review, the reviewers must use the standard criteria (including available clinical and non-clinical data etc.) defined by the PPB. Confidentiality must be maintained during the review. Per the CTRules and the G-KenyaCT, the PPB/ECCT’s review must consider:

• The reliability and robustness of the data generated in the clinical trial, taking into account statistical approaches, design of the clinical trial, and methodology, including sample size and randomization, comparator, and endpoints
• Compliance with the requirements concerning the manufacturing and import of IPs and auxiliary medicinal products
• Compliance with the labelling requirements
• The completeness and adequateness of the investigator's brochure

Regarding protocol amendments, the CTRules and the G-KenyaCT stipulate that any new information affecting the conduct/management of the trial, safety of the participants, and manufacture of the IP necessitating changes to the protocol, consent form, and trial sites require immediate submission of the amended documents to PPB for review and approval. Arrangements must be in place to take appropriate urgent safety measures to protect participants against any immediate hazard where new events relating to the conduct of the trial, or the development of the IP are likely to affect the safety of the participants. A copy of a favorable opinion letter from the EC on record must be submitted with the request for approval of a proposed amendment to the PPB. PPB approval must be obtained for all substantial amendments. Minor amendments or administrative changes may be implemented after getting the EC’s approval, but a record of these amendments must be kept for possible inspection by the PPB. See Submission Process and Submission Content sections for additional details on amendment submissions. Also, see the G-KenyaCT for examples of substantial amendments.

In addition, per the G-KenyaCT, the sponsor or the representative is required to request approval annually from the PPB at least six (6) weeks prior to the expiration of the previous approval.

Per the CTRules and the G-KenyaCT, the PPB may withdraw the authorization to conduct a clinical trial if it finds that the safety of the participants in the trial is compromised or that the scientific reasons for conducting the trial have changed. Additionally, per the CTRules, the PPB may revoke the approval if it determines that the IP has expired or is not usable.

As delineated in the G-KenyaCT, the PPB may inspect clinical trial sites to ensure that the generally accepted principles of good clinical practice (GCP) are met. The objectives of the inspection are to:

• Ensure that participants are not subjected to undue risks and that their rights, safety, and wellbeing are protected
• Validate the quality of the data generated
• Investigate complaints
• Verify the accuracy and reliability of clinical trial data submitted to the PPB in support of research or marketing applications
• Assess compliance with PPB guidelines and regulations governing the conduct of clinical trials
• Provide real-time assessment of ongoing trials

Per CRO-Inspect, the PPB is responsible for inspecting clinical trial and bioequivalence study sites that generate data for registration of medicines. The PPB requires that these sponsor and contract research organization sites comply with applicable good practices, including GCP, good laboratory practice (GLP), and good documentation practices. Based on risk assessments, the PPB will determine compliance with generally accepted good practice through inspections and, where appropriate, document reviews. In addition, see Cert-Emrgcy for information about GCP and good manufacturing practice certifications during emergencies.

Special Circumstances and Public Health Emergencies

The CTRules delineates that the PPB may, in special circumstances, authorize the conduct of a clinical trial under fast-track procedures or non-routine procedures. PPB may recognize and use clinical trial decisions, reports, or information from other competent authorities authorizing fast-track clinical trials. The special circumstances may include:

• A public health emergency
• The rapid spread of an epidemic disease
• Any other circumstance as may be determined by the PPB

The G-KenyaCT outlines PPB’s scope of assessment of a clinical trial application during a public health emergency. The PPB will conduct an expedited review and liaise with relevant stakeholders (including relevant ECs and other oversight bodies) to facilitate a holistic review of an application in a fast-track manner. The following prioritization criteria must be applied in the selection of applications for expedited review:

• Epidemiology of the emergency
• Morbidity and mortality associated with the emergency and/or condition under study
• Supporting scientific data/information available for the IP at the time of submission
• Feasibility of the implementation of the trial design within the context of the emergency
• Benefit impact of the intervention and/or trial design

In addition, PPB’s assessment will consider the following:

• The research does not compromise the response to an outbreak or appropriate care
• Studies are designed to yield scientifically valid results under the challenging and often rapidly evolving conditions of disasters and disease outbreak
• The research is responsive to the health needs or priorities of the disaster victims and affected communities and cannot be conducted outside a disaster situation
• The participants are selected fairly and adequate justification is given when particular populations are targeted or excluded, for example, health workers
• The potential burdens and benefits of research participation and the possible benefits of the research are equitably distributed
• The risks and potential individual benefits of experimental interventions are assessed realistically, especially when they are in the early phases of development
• Communities are actively engaged in study planning to ensure cultural sensitivity, while recognizing and addressing the associated practical challenges
• The individual informed consent of participants is obtained from individuals capable of giving informed consent
• Research results are disseminated, data are shared, and any effective interventions developed or knowledge generated are made available to the affected communities

National Commission for Science, Technology and Innovation

STI-Act stipulates that NACOSTI issues research licenses if it finds that the conduct of the research is beneficial to the country and will not adversely affect any aspect of the nature, environment, or security of the country. The license issued will have NACOSTI’s seal and will indicate the commencement and expiration of the research. In addition, NACOSTI maintains a register of all persons granted a license, which is available for public inspection during normal working hours free of charge.

KEN-31 states that if a research license application does not meet the conditions required under the STI-Act, NACOSTI must reject the application and communicate the reasons to the applicant. Any person may appeal NACOSTI’s decision to the Cabinet Secretary within 30 days of being notified of the decision. For approved research, NACOSTI may conduct an evaluation to assess compliance with the conditions of the license. If the research project has not been completed within the stipulated period, the researcher may apply for renewal of the license and pay the requisite fee. The researcher is expected to apply for renewal by attaching a progress report instead of a proposal. KEN-31 indicates that the duration of the research license is one (1) year.

National Medical Products Administration

In accordance with the DRR, the applicant is required to pay a fee after the drug registration is approved by the National Medical Products Administration (NMPA). As per the NMPA-No75-2020 and CHN-14, the NMPA charges the following drug registration fees to review and approve clinical trials as part of the drug registration process (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

• New drugs made in China: 192,000 Yuan
• New drugs made outside China: 376,000 Yuan
• Generic drugs made in China: 318,000 Yuan
• Generic drugs made outside China: 502,000 Yuan
• One-time import of drugs: 2,000 Yuan

As specified in NMPA-No75-2020 and CHN-14, the fees are based on one (1) active pharmaceutical ingredient or one (1) preparation as one (1) variety. If another specification is added, the registration fee will be increased by 20% according to the corresponding category.

For further guidance on fees associated with submitting supplementary applications and registering renewals for imported drugs and more, please refer to NMPA-No75-2020.

Payment Instructions

NMPA-No37-2022 indicates that to register a drug, the applicant should submit the drug registration application to NMPA’s Government Service Portal (CHN-71). The relevant center will conduct an administrative review. Next, the non-tax income collection management system of the Ministry of Finance will send an electronic payment code to the applicant in the form of a text message. The applicant can pay through the counter payment, self-service terminal, online payment, self-service POS card, bank exchange, or transfer and payment. The applicant will receive confirmation of electronic payment via email within 10 working days. Electronic payment documents have the same legal effect as paper instruments.

National Health Commission

Per HGR-AppGuide, the National Health Commission (NHC) does not charge a fee for an application for a human genetic resources (HGR) license in China.

Pharmacy and Poisons Board

Per the PPA and the G-KenyaCT, the sponsor or the representative is responsible for paying a fee to the Pharmacy and Poisons Board (PPB) to submit a clinical trial application for authorization. The PPB currently requires a non-refundable application fee of $1,000 USD, or the equivalent in Kenya Shillings at the prevailing bank rates.

Payment Instructions

As stated in Annex 2 of the G-KenyaCT, payment is to be made by a bank check payable to the “Pharmacy and Poisons Board” and presented to the PPB’s accounts office upon submitting the application.

Payment can also be made by electronic fund transfer (EFT) to the PPB Bank account, if required. The sponsor or the representative is responsible for all bank charges associated with the EFT. Details of the EFT payment should be obtained from the PPB prior to initiating such a transaction.

National Commission for Science, Technology and Innovation

As delineated in KEN-31, the National Commission for Science, Technology and Innovation (NACOSTI) charges a fee that varies depending on the applicant’s status as Kenyan or non-Kenyan, and standing as a researcher (i.e., student, public/private institution, private company). The fees are non-refundable and also apply to research license renewals. Details on additional requirements are provided in the Submission Content section.

• Student, Undergraduate/Diploma: East African Community (EAC) Countries – 100 Kenya Shillings; Kenyan Citizens – 100 Kenya Shillings; Rest of Africa – 200 Kenya Shillings; Non-Africans - $150 USD
• Research (Masters): EAC Countries – 1,000 Kenya Shillings; Kenyan Citizens – 1,000 Kenya Shillings; Rest of Africa – 2,000 Kenya Shillings; Non-Africans - $350 USD
• Research (PhD): EAC Countries – 2,000 Kenya Shillings; Kenyan Citizens – 2,000 Kenya Shillings; Rest of Africa – 4,000 Kenya Shillings; Non-Africans - $400 USD
• Post-Doctoral: EAC Countries – 5,000 Kenya Shillings; Kenyan Citizens – 5,000 Kenya Shillings; Rest of Africa – 10,000 Kenya Shillings; Non-Africans - $500 USD
• Public Institutions: Kenyan Citizens – 10,000 Kenya Shillings
• Private Institutions, Commercial/Market Research, Companies: Kenyan Citizens – 20,000 Kenya Shillings

See KEN-31 for information on service charges.

Payment Instructions

Per KEN-31, NACOSTI has migrated payment services for research licensing to the eCitizen platform (KEN-12). East African citizens have the following payment options on KEN-12 with a Kenya Shillings account: mobile money via Mpesa Express or Paybill Number 222222; or these other available payments via KEN-12:

• Airtel Money
• Kenya Commercial Bank
• Co-operative Bank
• Pesaflow Direct
• National Bank
• RTGS

KEN-31 indicates that non-Kenyans should use the US Dollar account on KEN-12 with these payment options:

• Kenya Commercial Bank (USD)
• Co-operative Bank (USD)
• NBK (USD)
• Equity Cash
• Debit/credit/prepaid card

Overview

As per the Measures-Ethics, the RegEthics, the EC-Guide, the NMPA-GCP-No57-2020, the DRR, and the DAL, an ethics committee (EC) must approve a clinical trial application prior to a sponsor initiating a clinical trial. Per the NMPA-NHC-No101-2019, each institution that conducts biomedical research is required to have an EC that is responsible for reviewing the scientific and ethical rationality of drug clinical trial programs, reviewing and supervising the qualifications of drug clinical trial researchers, supervising the development of drug clinical trials, and ensuring the ethics review process is independent, objective, and fair. Per the Measures-Ethics, institutions conducting life sciences and medical research involving people must establish ECs to carry out ethics reviews of such research. When the institution does not establish an EC, or the EC is unable to meet the needs of the review, the institution may entrust another institutional EC or a regional EC and implement extended supervision through follow-up reviews.

As described in the EC-Guide, China’s ethics review landscape comprises ethics expert committees and institutional ECs. Ethics expert committees are divided into the National Medical Ethics Expert Committee and provincial medical ethics expert committees. They are mainly responsible for guidance, consultation, and training, and generally do not undertake specific ethics review tasks. Institutional ECs are established by medical and health institutions in accordance with relevant requirements, and are mainly responsible for ethics review, training, and consultation in their institutions. Per the Measures-Ethics, provincial-level health departments establish and manage regional ECs. The EC-Guide states that the regional ECs and institutional ECs have the same status and are subject to the same requirements. ECs at different levels and in different institutions should strictly perform their respective duties, carry out effective communication and collaboration, adhere to the independence, impartiality, and objectivity of ethics review, and ensure that all medical research complies with ethical standards and requirements to fully protect the safety and rights of research participants. Following are brief overviews of each type of EC:

• The National Medical Ethics Expert Committee formulates standards for the construction of institutional ECs and ethics review guidelines, including review content, review procedures, additional protection for special groups, and review time limits; publishes ethics review requirements for high-risk activities in scientific and technological ethics; and formulates standard requirements for ethics review application materials.
• The provincial medical ethics expert committees promote the implementation of the above-mentioned ethics review standards and operating guidelines within the administrative region, promotes the construction and operation of the institutional ECs in the region, and standardizes the work of ethics review. The provincial medical ethics expert committees can make supplementary adjustments to the above-mentioned ethics review standards and operating guidelines in light of the cultural customs of the region.
• The institutional EC establishes and improves the ethics review work system and operating procedures in accordance with the guidance of the national and the provincial medical ethics expert committees, improves the conflict of interest management and quality control mechanisms, and ensures that the ethics review process is independent, objective, and fair. ECs at different levels and in different institutions should strictly perform their respective duties, which includes conducting and ensuring ethics reviews that protect the safety and rights of research participants.

Note that per the Measures-Ethics-Interp, the main framework and provisions of the Measures-Ethics and the RegEthics are generally consistent and both regulations should be followed. Some provisions in the newer Measures-Ethics have been refined and improved in combination with the requirements of new laws and regulations and the actual conditions of colleges, universities, and research institutes. The RegEthics will be reviewed and revised to closely align with the Measures-Ethics. (ClinRegs will monitor and update the China profile, as needed.)

Ethics Committee Composition

Pursuant to the NMPA-GCP-No57-2020, the EC composition must meet health authority requirements, and include members of various categories with different gender compositions. The EC members must be trained in ethics review and be able to review ethical and scientific issues related to clinical trials.

Per the Measures-Ethics, the EC-Guide, and the RegEthics, ECs should have at least seven (7) members. The EC-Guide and the RegEthics state that the ECs should be composed of multidisciplinary specialists in biomedicine, management, ethics, law, sociology, statistics, and other areas that collectively represent the qualifications and experience to provide a fair scientific and ethics review. The RegEthics states that in areas where minority ethnic groups reside, the institution should consider including members of those groups on the EC. The EC-Guide indicates that there should be one (1) member who does not belong to the institution and has no close relationship with the project researchers (the same member can meet both requirements). As delineated in the Measures-Ethics, EC members must be selected from experts in the fields of life sciences, medicine, bioethics, law, and people from outside the institution, and there must be members of different sexes. Ethnic minority members must be considered in ethnic minority areas. EC members must have the corresponding ethics review capabilities, and regularly receive training on ethical knowledge of life sciences and medical research and knowledge of relevant laws and regulations.

The Measures-Ethics, the EC-Guide, and the RegEthics provide that the EC can hire an independent consultant if necessary. The Measures-Ethics and the RegEthics state that the independent consultant advises on specific project issues under review and does not participate in the voting. The EC-Guide further indicates that there should be clear institutional regulations on the qualifications, hiring procedures, and job responsibilities of independent consultants, and the hiring process of independent consultants should be recorded and filed.

The EC-Guide and the RegEthics provide that the EC composition should include a chairperson and vice chairpersons, who are elected by committee members. The number of vice chairpersons is not specified in the guidelines. When the chairperson is absent, the deputy chair performs the chairperson’s duties. ECs should not accept any research project applications that do not comply with national laws and regulations. In addition, the EC should refuse to review any projects in which they have a conflict of interest. See the EC-Guide for additional guidance on managing ECs.

Terms of Reference, Review Procedures, and Meeting Schedule

As per the Measures-Ethics, the RegEthics, the EC-Guide, and the NMPA-GCP-No57-2020, each institution must have written SOPs, including a process to be followed for conducting reviews. To ensure the independence, objectivity, and impartiality of the ethics review process, the Measures-Ethics stipulates that the SOPs must include conflict of interest management and quality control mechanisms. Further, the EC must formulate an ethics review system in emergency situations (e.g., epidemic outbreaks) and clarify the time limit for review.

Per the Measures-Ethics, scientific research managers and other relevant personnel must conduct bioethics education and training. The EC-Guide specifies that all committee members should undergo basic professional training in scientific research ethics before starting their EC service at a provincial or above-level scientific research course and receive an ethics training certificate. Participation in continuing education should be on a continuous basis to ensure improvement.

As delineated in the Measures-Ethics, the term of office for members of ECs that review life sciences and medical research involving people must not exceed one (1) year, and they may be re-elected. The EC must have one (1) chairman and several vice chairmen, who must be elected by EC members through consultation and then appointed by the institution. EC members, independent consultants, and their staff must sign confidentiality agreements on sensitive information learned during ethics review work. The EC must accept the supervision of the institution's management. The EC may decide to approve, disapprove, approve after revision, re-examine after revision, continue research, suspend, or terminate the research under review, and must explain its reasons. The decision must be approved by more than one-half of all members of the EC. Members must vote after full discussion of the ethical issues involved in the study, and opinions inconsistent with the review decision must be recorded in detail.

The RegEthics states that EC members should agree to disclose their names, occupations, and affiliations, and to sign the reviews, confidentiality agreements, and a conflict of interest declaration. Each EC member term is five (5) years, after which they can be reappointed. Each institution that establishes an EC should also provide financial compensation to its committee members. EC review and approval decisions must take place during formal meetings. The majority of the total EC membership should be present to conduct reviews.

In addition, the NMPA-GCP-No57-2020 requires the EC to establish and implement the following written documents:

• Provisions on the composition, establishment, and filing of the EC
• The meeting schedule, meeting notice, and meeting review process sequence
• The initial review and follow-up review procedures of the EC
• A rapid review and approval procedure for minor amendments to the experimental protocol agreed to by the EC
• Procedures for promptly notifying researchers of review opinions
• Procedures for appealing ethics review opinions

The RegEthics and the NMPA-GCP-No57-2020 state that written records of all meetings and resolutions should be preserved for five (5) years following the completion of a clinical trial.

Overview

As per the G-KenyaCT, the G-ECBiomedRes, and KEN-30, Kenya requires an independent review of research through a National Commission for Science, Technology and Innovation (NACOSTI)-accredited ethics committee (EC) in one (1) of the local institutions charged with the responsibility of conducting research in human participants. KEN-25 provides a list of the accredited institutional ECs.

Ethics Committee Composition

As delineated in the G-ECAccred, institutional ECs should consist of at least seven (7) members, or an odd number above seven (7). The G-ECBiomedRes states that these members should be multidisciplinary and multisectoral in composition, collectively encompass relevant scientific expertise, balanced age and gender distribution, and include laypersons representing community interests and concerns. Per the G-ECAccred, the composition should meet the following requirements:

• At least one (1) member with knowledge and understanding of Kenyan law
• At least one-third of the members must be female, and one-third must be male
• At least one (1) member who is unaffiliated with the institution
• At least two (2) members must have research expertise and experience, one (1) of whom must be in the health field
• At least one (1) member must be a lay member
• For ECs reviewing clinical research, at least two (2) members must be clinicians, one (1) of whom is currently in active practice or clinical research
• Reflect the regional and ethnic diversity of the people of Kenya

The chairperson must also have some basic training and/or experience in bioethics and leadership. All EC appointments are the responsibility of the institution’s administrative head. See the G-ECAccred and the G-ECBiomedRes for detailed institutional EC requirements.

Terms of Reference, Review Procedures, and Meeting Schedule

Per G-ECBiomedRes, ECs need to have independence from political, institutional, professional, and market influences. As delineated in the G-ECAccred, the G-ECBiomedRes, and the STI-Regs, institutional ECs must operate within written standard operating procedures (SOPs) which delineate the EC’s process for conducting reviews. Per the G-ECAccred, SOPs should include but are not limited to information on EC scope, responsibility, and objectives, institutions served, committee functions, terms and conditions of member appointment, business procedures including meeting schedules and types of reviews, documentation, recordkeeping, and archiving procedures, quorum requirements, communication procedures, and complaint process and dispute resolution procedures. Per the G-ECAccred and the STI-Regs, these documents must be provided to NACOSTI.

Per the G-ECAccred, the quorum for NACOSTI-accredited EC meetings must be:

• At least 50 percent of the membership must form the quorum
• A lay person must be present in all meetings
• For ECs reviewing clinical research, at least two (2) members must be clinicians, one (1) of whom is currently in active practice or clinical research.

The G-ECBiomedRes also defines quorum requirements:

• The minimum number of members required to compose a quorum (e.g., more than half the members)
• The professional qualifications requirements (e.g., physician, lawyer, statistician, paramedical, or layperson) and the distribution of those requirements over the quorum; no quorum should consist entirely of members of one (1) profession or one (1) gender; a quorum should include at least one (1) member whose primary area of expertise is in a non-scientific area, and at least one (1) member who is independent of the institution/research site

Per G-ECBiomedRes, EC member terms of appointment should be established that include the duration of an appointment, the policy for the renewal of an appointment, the disqualification procedure, the resignation procedure, and the replacement procedure. A statement of the conditions of appointment should be drawn up that includes the following:

• A member should be willing to publicize their full name, profession, and affiliation
• All reimbursement for work and expenses, if any, within or related to an EC should be recorded and made available to the public upon request
• A member should sign a confidentiality agreement regarding meeting deliberations, applications, information on research participants, and related matters

Regarding training, EC members should have initial and continued education regarding the ethics and science of biomedical research. The conditions of appointment should indicate the availability and requirements of introductory training, as well as on-going continuing education. This education may be linked to cooperative arrangements with other ECs in the area, country, and region.

For detailed institutional EC requirements and information on other administrative processes, see the G-ECAccred and the G-ECBiomedRes. See KEN-17 and KEN-26 for examples of accredited EC submission and review guidelines.

Overview

According to the EC-Guide, the NMPA-GCP-No57-2020, and the NMPA-No11-2017, the primary scope of information assessed by the ethics committee (EC) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial, in accordance with the requirements set forth in the Declaration of Helsinki (CHN-84). Per the Measures-Ethics and the RegEthics, ethics reviews and relevant personnel must comply with the Constitution of the People's Republic of China and Chinese laws and regulations. The Measures-Ethics indicates that life science and medical research involving humans must respect research participants and follow the principles of beneficence, non-harm, and fairness, and protect privacy and personal information. Per the RegEthics and the EC-Guide, the EC must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable (See the Vulnerable Populations section for additional information about these populations). In addition, the EC is responsible for ensuring a competent review of all ethical aspects of the clinical trial protocol; evaluating the possible risks and expected benefits to participants; confirming the suitability of the investigator(s), facilities, and methods; and verifying the adequacy of confidentiality safeguards.

Per Measures-Ethics, life science and medical research involving humans is defined as research activities using biological samples and information data (including health records and behaviors) of research participants, specifically including the following:

• Activities that use methods such as physics, chemistry, biology, and traditional Chinese medicine to conduct research on human reproduction, growth, development, aging, etc.
• Activities that use methods such as physics, chemistry, biology, traditional Chinese medicine, psychology, and other methods to conduct research on human physiology, psychological behavior, pathological phenomena, disease etiology and pathogenesis, as well as disease prevention, diagnosis, treatment, and rehabilitation
• Activities using new technologies or products to conduct experimental research on the human body
• Activities that use methods such as epidemiology, sociology, and psychology to collect, record, use, report, or store biological samples, information data, and other scientific research materials (including health records, behaviors, etc.) related to life sciences and medical issues

The GeneEdit-Ethics states that human genome editing research should have important scientific and social value, and should be limited to medical interventions for treatment or prevention. Non-medical genomic changes to research participants are prohibited. Researchers and institutions should follow the GeneEdit-Ethics for principles and ethical behavior to guide human genome editing research.

Note that per the Measures-Ethics-Interp, the main framework and provisions of the Measures-Ethics and the RegEthics are generally consistent and both regulations should be followed. Some provisions in the newer Measures-Ethics have been refined and improved in combination with the requirements of new laws and regulations and the actual conditions of colleges, universities, and research institutes. The RegEthics will be reviewed and revised to closely align with the Measures-Ethics. (ClinRegs will monitor and update the China profile, as needed.)

Role in Clinical Trial Approval Process

As per the RegEthics, the NMPA-GCP-No57-2020, the DRR, the DAL, and the SC-Opinions-No42, the National Medical Products Administration (NMPA) and the EC must approve a clinical trial application prior to a sponsor initiating a clinical trial. As stated in the DRR, clinical trials of drugs must be reviewed and approved by an EC. The DRR indicates that the EC review may be submitted in parallel to the NMPA’s review, but the study cannot be initiated until after review and approval by the EC. The NMPA-GCP-No57-2020 and the RegEthics also state that the EC must review and approve any protocol amendments prior to those changes being implemented.

Per the Rules-MgmtHGR, the collection, preservation, use, and external provision of China’s human genetic resources (HGR) must comply with ethical principles and pass the ethics review of ECs that have been registered with the relevant management departments. Further, applications for administrative licenses for international scientific research cooperation on HGR must pass an ethics review in the respective countries (regions) where both parties are located. Where the foreign party is truly unable to provide the ethics review certification materials of the country (region) where it is located, it may submit the proof that the foreign party unit recognizes the ethics review opinions of the Chinese unit.

The Measures-Ethics, the EC-Guide, and the NMPA-GCP-No57-2020 provide that the EC’s scope of review must include the following (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

• Whether the institutions and researchers are competent; the qualifications and experience of the investigator meet clinical research requirements
• Whether the research plan meets the required scientific and ethical principles, has scientific and social value, does not violate the provisions of laws and regulations, and does not harm the public interest
• The degree of risk compared to the expected study benefit
• The informed consent process and whether the relevant information provided is complete and easy to understand, and whether the method for obtaining consent was appropriate
• Whether confidentiality measures have been taken to protect the participants’ privacy, personal information, and data
• Whether the guidelines for the selection and exclusion of participants are appropriate and fair
• Whether the participants are clearly informed of their rights in the research, including the right to equal treatment and that they can withdraw from the research at any time without reason and not be treated unfairly because of this
• Whether the participant received reasonable compensation for participating in the research, and in case of damage or death, whether the treatment and compensation measures are appropriate; participants must not be charged research-related fees for participating in the research
• Whether there is a designated contact for handling and obtaining informed consent and answering questions related to participant safety
• Whether appropriate measures are taken to minimize participant risks
• Potential conflicts of interest
• When conducting non-therapeutic clinical trials, if the participants’ informed consent is implemented by their guardians instead, whether the trial protocol gives full consideration to the corresponding ethical issues, laws, and regulations
• Whether the corresponding ethical issues, laws, and regulations are fully considered in the trial plan if the trial protocol clearly states that the participants or their guardians cannot sign an informed consent form (ICF) before the trial in an emergency
• Whether participants are forced or induced to participate in clinical trials due to improper influence, including whether the ICF has content that waives legal rights or exempts researchers, institutions, or sponsors from being responsible
• Whether the method, content, and timing of the release of research results are reasonable

Per the Measures-Ethics and the EC-Guide, the EC will make one (1) of the following decisions (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

• Approval: The EC unconditionally approves an initial review of the research protocol and will conduct follow-up reviews. The research can start immediately after approval.
• Approval after modification: The EC conditionally approves a research protocol if the research leader accepts the EC’s proposed amendments.
• Review after modification: If the EC needs more substantive information about the research project under review, it will decide to suspend the deliberation until the committee receives new information.
• Approve continuation of research.
• Not approved: The EC votes against a research proposal. The reasons for disapproval must be communicated to the research leader, who is given an opportunity to defend the research.
• Suspension or termination of research: The EC suspends or terminates a research project.

The Measures-Ethics specifies that the EC must conduct the review and issue its opinion within 30 days of acceptance of the materials.

The Measures-Ethics states that before the implementation of research approved by the EC, researchers, ECs, and institutions must truthfully, completely, and accurately upload information to the registration platform (CHN-53), including research, ethics review opinions, and institutional review opinions in accordance with the requirements of the national medical research registration and filing information system, and promptly update the information according to the progress of the research. Researchers, ECs, and institutions are encouraged to upload information in real time during the study management process.

The NMPA-GCP-No57-2020 specifies that the EC must pay attention to and clearly require investigators to report in a timely manner the following: deviations or modifications to the trial protocol to eliminate emergency hazards to participants; changes that increase the risk to participants or significantly affect the implementation of clinical trials; all suspicious and unexpected serious adverse reactions; and new information that may adversely affect the safety of participants or the implementation of clinical trials. The EC has the right to suspend or terminate clinical trials, as needed. Finally, the EC must accept and properly handle requests from participants. Per the EC-Guide, if there are accidental injuries or violations during the research project, the EC has the right to request the suspension or termination of an approved research project. Further, the EC reviews amendments to the protocol and informed consent form, and reviews serious adverse events and violations of the protocol. The Measures-Ethics states that when a serious adverse event is reported, the EC must conduct a timely review to determine whether the measures taken by researchers to protect the personal safety and health rights and interests of research participants are adequate, reassess the risk-benefit ratio of the research, and issue review opinions.

As delineated in the NMPA-No34-2022, protocol changes that result in updating the investigator’s brochure, ICF, or other relevant documents should be reported to the EC by the sponsor. The Measures-Ethics indicates that if approved research requires revision of the research plan, informed consent, recruitment materials, or other materials provided to research participants, the researcher must submit the revised documents to the EC for review. Further, the EC must conduct follow-up reviews at least annually in accordance with relevant reports submitted by the investigators. The follow-up review must include the following considerations:

• Whether the research is conducted in accordance with the approved research plan and reported in a timely manner
• Whether the research content was changed without authorization during the research process
• Whether changes or new information increase the risk to research participants or significantly affect the implementation of the research
• Whether it is necessary to suspend or terminate the research early
• Other content that needs to be reviewed

Per the EC-Guide, the EC has the right to request regular follow-up reviews of approved research projects based on the possibility and degree of research risks. The RegEthics provides that the EC must designate members to conduct follow-up examinations of approved research projects. The number of members for follow-up review must not be less than two (2), and the review is required to be reported to the EC. Further, the EC may apply to the provincial medical ethics expert committees to provide advice on the ethics review of research that involves a relatively high-risk or special population.

Expedited Review

As delineated in the Measures-Ethics, the EC may conduct expedited review of research in the following circumstances:

• Research whose risk is not greater than the minimum risk
• Research in which the approved research protocol is slightly modified and does not affect the risk-benefit ratio of the research
• Follow-up review of approved research
• Research conducted by multiple institutions, when the EC of the participating institution confirms the ethics review opinion issued by the lead institution, etc.

Where the situation is urgent, an ethics review must be promptly carried out. In the case of emergencies such as outbreaks, ethics reviews and review opinions are generally carried out within 72 hours, but the requirements and quality of ethics reviews must not be reduced. For expedited review, the EC chairman designates two (2) or more members to conduct the ethics review and issue review opinions. The review opinions must be reported at the EC meeting. If it is discovered during this review that there is a change in the risk-benefit ratio of the research, there is a disagreement among the review members, or the review members propose that a meeting review is required, etc., then a full review procedure must be held.

During an outbreak of an epidemic, the EC-Guide advises ECs to adhere to the highest scientific and ethical standards for independent review of the research project to ensure balancing of quality and timeliness. The materials provided by the researcher can be simplified according to the situation. The EC should pay special attention to the informed consent process as participants may be improperly exploited due to their obvious vulnerability, especially when it involves high-risk and risk-uncertain research. It should be ensured that participants choose to participate voluntarily and independently after being fully informed and fully understanding the possible risks of research. Research participants or the legal representative/guardian must be allowed to withdraw from research unconditionally at any stage. See the EC-Guide for additional guidance on the EC review when there is a major epidemic risk.

Multicenter Studies

Per the Measures-Ethics, research carried out in multiple institutions may establish collaborative mechanisms for ethics review, ensuring that all institutions follow the principles of consistency and timeliness. Both the lead institution and the participating institution must organize an ethics review. The EC of the participating institution must conduct a follow-up review of the research in which the institution participates. Where establishments cooperate with enterprises and other institutions to carry out life science and medical research involving humans, the institutions must fully understand the overall situation of the research, clarify the scope of use and handling methods of biological samples and information data through agreements subject to ethics review and follow-up review, and supervise their proper disposal after the research is completed.

Per the EC-Guide, the review of international cooperative research projects requires ethics review by the lead unit. For cooperative research projects conducted in China, the trial protocols should be submitted to the EC for a single-review process and should be consistent, though the EC will accept that informed consent may vary slightly in different institutions. The RegEthics also provides that multicenter research may establish a collaborative review mechanism to ensure that the research institutions of each project follow the principles of consistency and timeliness. The lead agency EC is responsible for project review and confirmation of the ethics review results of participating institutions. ECs of the participating institutions must conduct an ethics review of the research in which the institution participates in a timely manner and provide feedback to the lead agency for review.

Exemption from Ethics Review

The Measures-Ethics states that ethics review may be exempted where human information data or biological samples are used to carry out life science and medical research involving humans if the research does not cause harm to the human body or does not involve sensitive personal information or commercial interests. This is to reduce unnecessary burdens on scientific research personnel and promote the development of life science and medical research involving people. The exemption may apply in the following circumstances:

• Using lawfully obtained public data or conducting research through data generated by observing and not interfering with public conduct
• Using anonymized information and data to carry out research
• Using existing human biological samples to carry out research, and the source of the biological samples complies with relevant laws and regulations and ethical principles; the relevant content and purpose of the research are within the scope of the informed consent; and the research does not involve the use of human germ cells, embryos, reproductive cloning, chimerism, and heritable gene manipulation
• Carrying out research using human-derived cell lines or cell lines derived from biobanks, where the relevant content and purpose of the research are within the scope authorized by the provider, and do not involve activities such as human embryonic and reproductive cloning, chimerism, and heritable gene manipulation

Overview

According to G-ECBiomedRes, the primary scope of information assessed by the institutional ethics committees (ECs) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. The G-ECAccred further states that the National Commission for Science, Technology and Innovation (NACOSTI) accredits ECs in order to uphold the standard of ethics review in the country; develop public confidence and trust in the national research system; facilitate equitable access to research and human health records in health facilities; and facilitate coordination and collaboration among ECs. See the G-ECAccred and the G-ECBiomedRes for detailed ethical review guidelines.

Role in Clinical Trial Approval Process

As per the G-KenyaCT and KEN-21, the Pharmacy and Poisons Board (PPB)’s review and approval of a clinical trial application is dependent upon obtaining approval by an accredited institutional EC. Consequently, the PPB and EC reviews may not be conducted in parallel.

As set forth in the G-ECBiomedRes, ECs must be constituted to ensure an independent and competent review and evaluation of all ethical aspects of clinical trials. ECs must review research involving human participants to ensure they meet these ethical principles:

• Respect for persons, including respect of autonomy, protection of vulnerable groups, and protection of privacy and confidentiality
• Beneficence
• Justice, which in research means equitable distribution of the benefits and the burdens

For additional details on the principles and benchmarks for ethical review, see G-ECBiomedRes.

Per the G-ECBiomedRes, expedited review may be permitted for protocols involving no more than minimal risk to research participants.

The G-ECBiomedRes indicates that all ECs should carry out regular monitoring of approved protocols involving human participants. In case of any adverse events, the EC should report this immediately to Kenya’s National Bioethics Committee (NBC).

Per the G-ECBiomedRes, with collaborative research projects, the collaborating investigators, institutions, and countries must function as equal partners with safeguards to avoid exploitation of local researchers and participants. An external sponsoring agency should submit the research protocol to their country’s EC, as well as the Kenyan EC where the research is to be conducted. Further, this research must be responsive to the health needs of Kenya and reasonably accessible to the community in which the research was conducted. Consideration should be given to the sponsoring agency agreeing to maintain health services and faculties established for the purposes of the study in Kenya after the research has been completed. Such collaborative research must have a local/Kenyan co-principal investigator.

No applicable requirements.

As per the G-KenyaCT, G-ECBiomedRes, and KEN-30, Kenya requires an independent review of research through a National Commission for Science, Technology and Innovation (NACOSTI)-accredited ethics committee (EC) in one (1) of the local institutions charged with the responsibility of conducting research in human participants. The EC fee to review a clinical trial application will vary depending on the institution. See KEN-25 and KEN-38 for lists of NACOSTI-accredited institutional ECs. For an example of institutional fee requirements charged by the Scientific and Ethics Review Unit (SERU) at the Kenya Medical Research Institute (KEMRI), see KEN-27.

Overview

Per the NMPA-NHC-No101-2019, the National Medical Products Administration (NMPA) oversees and supervises the registration and filing of clinical trial institutions. Drug clinical trials must be conducted in registered clinical trial institutions that meet the applicable requirements, which include having an ethics committee (EC).

Registration, Auditing, and Accreditation

The RegEthics states that all biomedical research institutions in China should establish their own ECs. Per SC-Opinions-No42, the NMPA adopted a registration system for institutions with qualifying conditions to be entrusted to conduct clinical trials and operate ECs. An institution is entrusted to conduct clinical trials if it has an EC and the main investigators of clinical trials have senior professional titles and have participated in more than three (3) clinical trials, among other conditions. To apply for qualification, institutions must submit an application via the online filing system (CHN-82) and fulfill the requirements pursuant to the NMPA-NHC-No101-2019. Per the Measures-Ethics, institutions must register the EC within three (3) months of its establishment and upload the information to CHN-82. Medical and healthcare institutions must register with the appropriate oversight authority. Other institutions must register with the competent department at a higher level according to their administrative affiliation. The EC must submit the previous year's work report to the appropriate institutional department before March 31^st of each year, including:

• A list of personnel and resumes of committee members' work
• The EC charter
• Work systems or relevant work procedures
• Other relevant materials required by the appropriate department

When the above information changes, the institution must promptly update the information to the appropriate institutional department.

As delineated in the RegEthics and interpreted in CHN-41, the National Health Commission (NHC) is responsible for managing ECs nationwide, organizing the inspection and management of the national ethics review of biomedical research involving human beings, establishing the National Medical Ethics Expert Committee, and for developing policies relating to ethics review. The National Medical Ethics Expert Committee conducts research on major ethical issues in research involving humans and provides policy advice and guides the provincial ECs. Per CHN-3, China established a National Science and Technology Ethics Committee to strengthen the ethics governance system. Further, the SC-EthicalGov establishes principles and guides the committee in its responsibility to develop and coordinate the ethics governance system.

The EC-Guide describes the inspection and oversight mechanisms among the ECs in China. The National Medical Ethics Expert Committee formulates an inspection and evaluation indicator system for institutional ECs, including review quality, review efficiency, committee member capabilities, conflict of interest management, etc., to guide provincial medical ethics expert committees in carrying out ethics inspections within the region. The National Medical Ethics Expert Committee also inspects, evaluates, and supervises the work of provincial medical ethics expert committees. The provincial medical ethics expert committees are responsible for conducting regular inspections and evaluations of the ethics review work of medical institutions and regional ECs within the administrative area at the same level, making recommendations on how to manage non-standard ethics review work, and may establish an information disclosure mechanism based on actual conditions. Institutional ECs should check and evaluate the indicator system, continuously improve their operations, and actively cooperate in completing various inspections and evaluations. Regular self-evaluation is encouraged to improve work quality and review efficiency.

As delineated in the RegEthics, the provincial, autonomous regional, and municipal health authorities also have ECs set up under their own administration. The provincial medical ethics expert committees assists in promoting the institutionalization and standardization of the ethics review work of human biomedical research in its administrative region, and guides, inspects, and evaluates the work of the institutional ECs in the administrative region. It also performs training and consulting work. The local health administrative department at or above the county level supervises and manages the ethics review work of biomedical research involving people in its administrative region. Per the Measures-Ethics, provincial-level health departments, in conjunction with relevant departments, must formulate measures for the establishment and management of regional ECs. The regional EC must file with the provincial health department and upload information in CHN-82.

For additional information about oversight of ECs, including inspections, see the RegEthics.

Overview

As set forth in the STI-Act and KEN-32, the National Commission for Science, Technology and Innovation (NACOSTI) is the central body responsible for the oversight, promotion, and coordination of research. NACOSTI’s role is to regulate and ensure quality in the science, technology, and innovation sector, and to advise the Kenyan government on related matters. As per the G-ECAccred, NACOSTI has delegated the task of reviewing research proposals for ethical clearance to accredited institutional ethics committees (ECs) to ensure that research conducted in the country observes high research ethics standards.

Per the G-ECBiomedRes, Kenya's National Bioethics Committee (NBC) advises NACOSTI on research ethics. In addition, NBC offers dispute resolution if an applicant is dissatisfied with the decision of an EC. Finally, the NBC must terminate research at any stage if it is found to be harmful to the participants.

Registration, Auditing, and Accreditation

As per the STI-Regs and the G-ECAccred, NACOSTI is responsible for accrediting institutional ECs. Per the G-ECAccred, the application requirements for accreditation are:

• A completed application form (KEN-10 or Annex III of the G-ECAccred)
• Copy of the standard operating procedures (SOPs)
• Copies of abridged curriculum vitaes (CVs) (no more than four (4) pages) for each member of the proposed EC (including the training attended)
• Profile of the organization/institution detailing the areas of competence (no more than four (4) pages)

Upon creating an account in NACOSTI’s Kenya National Research Information System (KENRIS) (KEN-23), users can perform the following functions:

• Researchers: Apply for researcher registration, register and track applications, and maintain research profile
• Research Institutions: Apply for new research institution registration, maintain/update data, and submit annual reports
• Institutional ECs: Apply for accreditation, preview and track accreditation proposals, submit annual reports, and maintain/update data

Per the G-ECAccred, NACOSTI issues a certificate of accreditation to accredited institutional ECs, which is valid for three (3) years from the date of NACOSTI’s notification. All accredited ECs must submit annual reports to NACOSTI by July 31st for review and monitoring. Applications for renewal of accreditation should be made six (6) months before expiry of the accreditation period. Failure to renew accreditation or failure to maintain the appropriate standards for continuity of accreditation will mean that the accredited status of the EC will lapse at the end of the current accreditation period. Accreditation must be terminated if the accredited committee fails to maintain the required standards. For re-accreditation review purposes, ECs must provide the SOPs under which they will operate. The SOPs are not required as part of the annual reporting process, unless they have been amended, but are required to be stated/included for the re-accreditation review process (every three (3) years). See the G-ECAccred for additional details on the accreditation process.

See the Site/Investigator Selection section for more information on the sponsor and site’s registration and application requirements.

Overview

As per the DRR, the National Medical Products Administration (NMPA) grants permission for clinical trials to be conducted in China pursuant to the drug registration process, in accordance with the DAL, the VaccineLaw, and other laws and regulations. The NMPA-GCP-No57-2020, the DRR, the DAL, and the SC-Opinions-No44 require the sponsor to obtain NMPA and ethics committee (EC) approvals of a clinical trial application. As stated in the DRR, EC review may be submitted in parallel to the NMPA’s review, but the study cannot be initiated until after review and approval by the EC.

Per the NHC-HGRmgt, the National Health Commission (NHC) is responsible for China’s management of human genetic resources (HGR). (Note that per SC-Order777 and NHC-HGRmgt, management of HGR was transferred from the Ministry of Science and Technology (MOST) to NHC, effective May 1, 2024). The NHC-HGRmgt states that the original application process and platform (CHN-6) remain unchanged. Per the Rules-MgmtHGR, the collection, preservation, use, and external provision of China’s HGR must comply with ethical principles and pass the ethics review of ECs that have been registered with the relevant management departments. Further, with applications for administrative licenses for international scientific research cooperation, the HGR project must pass an ethics review in the respective countries (regions). As part of the application filing for international cooperative clinical trials, NMPA approvals, notices, and/or filing registration must be obtained in advance, along with the EC approvals. Therefore, EC and MOST (now the NHC) review cannot occur in parallel. (Please note that SC-Order777 amends the MgmtHumanGen to reflect the transfer of HGR management from MOST to the NHC, but the Rules-MgmtHGR has not yet been amended to show the transfer.)

Regulatory Submission

National Medical Products Administration

The NMPA-No50-2018 establishes the broad submission procedures for clinical trials, which are detailed below through implementing regulations and guidance. The DRR states that a Chinese legal entity must submit the drug registration application. Clinical trial applications are also considered drug registration applications. Overseas drug manufacturers without legal representation in China must apply for drug registration through Chinese legal persons to handle relevant drug registration matters.

The applicant should prepare materials and apply for a communication meeting with the NMPA’s Center for Drug Evaluation (CDE) in accordance with the requirements of the NMPA-No48-2020, which includes requirements for different categories of meetings involving applications for new drugs. The NMPA-No48-2020 includes the application form (Appendix 1) and communication meeting materials (Appendix 2). The meeting’s purpose is to determine the integrity of the clinical trial application data and the sponsor’s ability to ensure the participant’s safety. If existing or supplemental data can support the clinical trial, then the applicant can submit a clinical trial application after the meeting or after supplementing the data. The NMPA-No51-2023 reaffirms the required pre-trial meeting and states that the applicant must submit a communication application to the CDE before 1) applying for the first clinical trial of a new drug and 2) before completing the exploratory clinical trial and conducting the confirmatory (or critical) clinical trial. The NMPA-No23-2023 provides guidance on common issues and general requirements for the Phase III pre-clinical trial meeting with the CDE in regards to innovative drugs.

Per the NMPA-No50-2018, the applicant may directly submit a clinical trial application without requesting a communication meeting with the CDE in the following cases: they clearly understand the technical guidance; have sufficient experience in drug clinical trials; can ensure the quality of data in the application; or the application is for a multicentered international clinical trial being conducted in parallel that has permission to conduct the clinical trials in countries or regions with an established and functional regulatory and monitoring infrastructure. In addition, the NMPA-No48-2020 stipulates that the application for conditional approval and/or the application for priority review and approval procedures must be communicated and confirmed with the CDE before submittal. (See below for procedures on priority review and approval.)

CHN-14 states that Chinese legal entities must submit application materials to the NMPA/CDE for a formal process review (including checking the electronic materials as described below). NMPA will process clinical trial applications within five (5) working days if the study falls within the scope of its authority; the application materials are complete and comply with the prescribed format; and if all required supplementary materials are submitted. If accepted, the CDE then organizes and conducts its review of the clinical trial application on behalf of the NMPA. As required in the ElectronicApps-Rqts and the NMPA-No110-2022, all documents for drug registration applications (including clinical trial applications, letters of commitment, declarations, and supplemental material) must be submitted electronically on CD-ROM to the CDE, in accordance with the current regulations, technical requirements for electronic CD-ROMs of application materials, and electronic file structure of drug registration applications. The ElectronicApps-Rqts clarifies that the CDE no longer accepts paper documents for administrative licensing by mail, except for applications that were accepted before January 1, 2023 and must continue to submit supplementary material in paper format. The applicant or registered agent is required to electronically sign the electronic declaration materials; the application and electronic seal can be found in the CDE’s Applicant Window (CHN-58). For details on the cover requirements for CD-ROM cases and the cover of the file bag, refer to Annex 1 in ElectronicApps-Rqts.

As indicated in CDE-Reloctn, the applicant should fill in and submit the relevant information in the "Online Appointment for Submission of Materials" module under the "Online Appointment" item in the "Applicant's Window" column of CDE’s Applicant Window (CHN-58). To mail CDs and other application materials in electronic format, applicants should use the following mailing address:

Business Management Office of the Center for Drug Evaluation
State Drug Administration
Room 102, Building 2
District 2, No. 22 Guangde Street
Beijing Economic and Technological Development Zone
Beijing, 100076
P.R. China

Per the ElectronicApps-Rqts, after receiving the disc submitted by the applicant, the CDE will determine if the disc can be read normally, passes the electronic signature verification, and has no computer viruses. If the disc does not pass these reviews, the CDE will notify the applicant and request resubmittal; the original disc will be disposed of in accordance with the CDE’s destruction procedures. If accepted, the CDE will push the electronic documents to the "Drug Business Application System" and "Drug eCTD Registration System" and the applicant is notified by SMS.

The ElectronicApps-Rqts provides additional requirements on the arrangement of discs:

• Submit one (1) complete set of electronic application materials on CD-ROM (including clinical trial database, if applicable) for review
• Submit one (1) complete set of electronic declaration materials on CD-ROM (including clinical trial database, if applicable) for verification at the same time.
• For clinical trial database data, the relevant materials must be prepared in a separate set of CD-ROMs.

Additionally, the ElectronicApps-Rqts states that within five (5) working days after the acceptance of the drug registration application, the applicant must upload a Microsoft Word file of the application materials (e.g., pharmacy, non-clinical, and clinical reviews) through the CDE’s Applicant Window (CHN-58). The documents related to pharmaceutical materials (active pharmaceutical ingredients (APIs), pharmaceutical excipients, and pharmaceutical packaging materials) should be uploaded as PDF files. Further, per the DRR, supplementary materials (e.g., clinical trial research materials, consultations, and data submittals) are handled via the CDE’s Applicant’s Window (CHN-58).

Note that per CHN-14, all application materials must be in Chinese with the original language attached, and materials in other languages can be attached as reference. Chinese translations should be consistent with the original text.

The NMPA-No44-2020, the NMPA-No43-2020, and the NMPA-No10-2018 require applicants to apply the International Council for Harmonisation (ICH)’s M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) (CHN-38) to the registration applications for drugs, therapeutic biological products, and vaccines. See the NMPA-No16-2018 for guidance on Phase I clinical trial applications. To standardize the submission of drug clinical trial data, meet the newly revised drug registration application data requirements, and improve the efficiency of drug review, the NMPA-No16-2020 provides guidance on the content and format of clinical trial data. The guidance is based on the data submission requirements of international regulatory agencies, including the Clinical Data Interchange Standards Consortium (CDISC).

For administrative support, applicants can request a meeting and/or consult the NMPA’s Government Service Portal (CHN-71).

Bioequivalent Studies

Per the NMPA-No230-2015, for generic drugs, a bioequivalence study will only need to be filed with the NMPA. The applicant should submit record filing materials to the NMPA 30 days before submitting the bioequivalence studies. For the generic drug filing, the applicant must obtain EC approval and sign a clinical study agreement with the clinical site prior to filing the bioequivalent study. See CHN-70 for handling guidelines for bioequivalent drugs.

Priority and Special Procedures

In addition, the DRR authorizes regulatory pathways for priority review and approval (including for breakthrough therapeutic drugs), conditional approval and special approval procedures. Per CHN-69, after the registration application is transferred to the CDE, applicants can apply for accelerated review directly to the CDE at CHN-58. CHN-69 contains the application and additional procedures for submitting applications for priority review and approval. As per the SC-Opinions-No44, the NMPA-No230-2015, and the NMPA-No51-2016, a new drug classification system, priority review for innovative drugs and those deemed to have an urgent clinical need, and other changes help China to be more innovative and expedite reviews. As delineated in the NMPA-No23-2018, for drugs listed overseas and that treat seriously life-threatening conditions, if there is no ethnic difference in the study, they can submit the clinical trial data obtained overseas and directly apply for the drug listing registration.

Protocol Changes

As delineated in the NMPA-No34-2022, when there is a protocol change during a clinical trial, the sponsor should follow these submission guidelines:

• For substantial changes that may significantly increase the risk to participant safety, the sponsor must submit a clinical trial application as per the instructions above
• For substantial changes that do not significantly increase participant safety risk, but may significantly affect the scientific validity and the reliability of the data, the sponsor should submit a communication meeting application to the CDE (see above)
• Non-substantive changes can be implemented after being approved by the EC and filed with the NMPA
• After the protocol is changed, the sponsor must update the drug clinical trial registration (See the Initiation, Agreements & Registration section) and submit the relevant updates in progress reports

National Health Commission

Per the MgmtHumanGen and the Rules-MgmtHGR, the foreign entity and the Chinese entity must jointly file an application for approval to MOST (now the NHC) and pass an ethics review in the partners’ countries. The only exception to the MOST (now the NHC) approval requirement is international collaboration in clinical trials that do not involve the export of Chinese HGR materials such as organs, tissues, or cells comprising the human genome, genes, or other genetic substances—these must be filed with MOST (NHC), which will generate a record number (see below for steps) and pass an ethics review in the partners’ countries.

As stated in the HGR-AppGuide, the HGR license application must be submitted to NHC via the Human Genetic Resources Service System (CHN-6), including application information and supporting materials. After verification, the system posts updates for the applicant.

See HGR-InfoSys for background on the online platform and contact information. For help with the online platform, contact Zhu Min, NHC’s China Biotechnology Development Center, at 010-88225151 or 010-88225168; or the information system support at 17610386080.

Ethics Review Submission

Each institutional and regional EC has its own required submission procedures.

Overview

In accordance with the PPA, the STI-Act, the CTRules, the G-KenyaCT, the G-ECBiomedRes, KEN-21, and KEN-16, Kenya requires the sponsor or the representative to obtain clinical trial authorization from the Pharmacy and Poisons Board (PPB)’s Expert Committee on Clinical Trials (ECCT) and an independent ethics review through a National Commission for Science, Technology and Innovation (NACOSTI)-accredited ethics committee (EC) in a local institution. In addition, the STI-Act and KEN-31 specify that applicants must obtain a research license from NACOSTI prior to initiating a study. The G-KenyaCT also states that the PPB review and approval process may not be conducted in parallel with the EC review. EC approval must be obtained prior to applying for PPB approval.

Regulatory Submission

Pharmacy and Poisons Board

As described in the G-KenyaCT and KEN-16, the sponsor or the representative is expected to submit the clinical trial application electronically via the PPB online system (KEN-16). The clinical trial application form is available in KEN-16. Per the G-KenyaCT, in the event of a multicenter clinical trial, the sponsor should only file one (1) application to the PPB. According to KEN-34, all application documents should be signed, dated, and version referenced, if applicable, and should be in English. See Annex 7 of the G-KenyaCT to view a flowchart of the submission and approval process.

Per the G-KenyaCT, upon receipt of a clinical trial application, the PPB’s Clinical Trial Division of the Product Safety Department screens the application package for completeness. When an application for a clinical trial is accepted, an acknowledgement of receipt will be issued with a reference number for each application. This PPB/ECCT reference number must be quoted in all correspondence concerning the application in the future. This will be communicated through email to the applicant or through KEN-16.

Per the G-KenyaCT, sponsors (applicants) can request pre-submission meetings with the PPB to discuss pertinent issues prior to making a formal submissions. The request must be made via KEN-16 or in an official letter and include the following information:

• Background information on the disease to be treated
• Background information on the product
• Quality development
• Non-clinical development
• Clinical development
• Regulatory status
• Rationale for seeking advice
• Proposed questions and applicant’s positions

In addition, per the G-KenyaCT, the letter must be addressed to the Chief Executive Officer of the PPB and sent to admin@pharmacyboardkenya.org and copied to cta@pharmacyboardkenya.org. The request for a meeting should propose two (2) different dates for the meeting at least three (3) weeks away.

Per G-KenyaCT, any new information that affects the conduct/management of the trial; safety of the participants; and manufacture of the product necessitating changes to the protocol, consent form, and trial sites, etc. will require immediate submission of the amended documents to the PPB for review and approval. Minor amendments or administrative changes may be implemented after getting the EC’s approval, but a record of these amendments must be kept for possible inspection by the PPB.

National Commission for Science, Technology and Innovation

Per KEN-31, an application for a NACOSTI research license should be submitted online via the Research Information Management System (RIMS) (KEN-24).

Ethics Review Submission

Each institutional EC has its own required submission procedures, which can differ significantly regarding the application format and number of copies. See KEN-17 for an example of a NACOSTI-accredited EC’s guidelines.

Regulatory Authority Requirements

National Medical Products Administration

As delineated in the NMPA-No51-2023, the applicant must submit the following materials to the National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) to have a communication meeting prior to submitting a clinical trial application for an exploratory clinical trial:

• The overall clinical development plan
• A complete first clinical trial protocol
• A risk management plan
• A subsequent clinical trial protocol, if applicable
• Non-clinical research review
• Pharmaceutical research review, etc.
• A clear statement of the issues to be communicated

Next, the NMPA-No51-2023 states that prior to completing the exploratory clinical trial, the applicant must submit the following to CDE for another meeting to discuss conducting the confirmatory (or critical) clinical trial and the subsequent clinical trial protocol:

• A preliminary analysis of the results of the early clinical trials that have been conducted
• A scientific, reasonable, complete, and feasible confirmatory (or critical) clinical trial protocol based on the existing clinical trial data
• A risk management plan
• A review of non-clinical studies
• A review of pharmaceutical studies, etc.

Per the DRR, after completing the pharmacology, toxicology, and other studies supporting the clinical trials of the drug, the applicant must submit relevant research materials to the NMPA. When applying for drug registration, the applicant must provide true, sufficient, and reliable data, materials, and samples to prove the safety, effectiveness, and quality controllability of the drug. In cases where overseas research materials and data are used to support drug registration, its source, research institution, or laboratory conditions, quality system requirements, and other management conditions should conform to prevailing international principles and applicable Chinese drug registration management requirements. CHN-14, CHN-70, and CHN-69 contain application materials and handling guidelines covering domestic drug and biological product clinical trial applications; imported drug and biological product clinical trial applications; priority review application procedures; and bioequivalence filing procedures. In general, the applications require information about the drug (e.g., names, formulation and ingredients, indications, and packaging), patents, the applicant, and the institution(s). In addition, the applications require a declaration attesting that the application and associated materials comply with the DAL, the DRR, and other applicable laws and regulations. The application and submitted data and samples must be true and legal, and they should not infringe on the rights and interests of others. The content of the electronic file submitted must be the same as the printed file. If any data is found to be false, the applicant bears the legal consequences caused by it.

The NMPA-No51-2023 requires the applicant to submit the following materials with the clinical trial application, in accordance with the NMPA-No44-2020 and the NMPA-No43-2020:

• A complete clinical research and development protocol
• A complete plan for the proposed clinical trial
• A risk management plan
• A framework for the subsequent clinical trial plan (if applicable)

The NMPA-No16-2018 provides guidance on technical information to be included in the application dossier for Phase I clinical trials:

• Introductory description and overall research plan
• Researcher’s manual (Investigator’s Brochure (IB))
• Clinical trial plan
• Pharmacy research information
• Pharmacology and toxicology information
• Description of previous clinical use experience
• Overseas research material

Per the SC-Opinions-No42, the NMPA-No10-2018, and CHN-14, that applicants should apply the International Council for Harmonisation (ICH)’s M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) (CHN-38) to the registration applications for drugs, therapeutic biological products, and vaccines.

See CHN-20 for additional analyses and overview of the China clinical trial application submission content.

National Health Commission

Per the NHC-HGRmgt, the National Health Commission (NHC) is responsible for China’s management of human genetic resources (HGR). (Note that per SC-Order777 and NHC-HGRmgt, management of HGR was transferred from the Ministry of Science and Technology (MOST) to NHC, effective May 1, 2024. Please note that SC-Order777 amends the MgmtHumanGen to reflect the transfer of HGR management from MOST to the NHC)). The NHC-HGRmgt states that the original application process and platform (CHN-6) remain unchanged.

The MgmtHumanGen requires that applications for a license to collect or preserve HGR meet the following conditions:

• Applicants prove legal person status
• The purpose of collection and/or preservation is clear and legal
• The collection and/or plan is reasonable
• In the case of preservation, the premises where the HGR will be deposited is legal
• Proof of passing ethics review
• Having a department and management system responsible for the management of collecting and/or preserving the HGR
• Having premises, facilities, equipment, and personnel suitable for collection and/or preservation activities

As delineated in the MgmtHumanGen, the application for international collaborative scientific research using China’s HGR must demonstrate:

• The research is not harmful to the public health, national security, or social public interests of China
• The two (2) parties to the cooperation are a Chinese entity and a foreign entity with legal person status and have the basis and ability to carry out relevant work
• The purpose and content of the cooperative research are clear and legal, and the duration is reasonable
• The cooperative research plan is reasonable
• The HGR to be used are of legal origin, and their types and quantities are consistent with the research content
• The research passed an ethics review of the respective countries (regions) of the cooperation parties
• The ownership of the research results is clear, and there is a reasonable and clear profit distribution plan

Information on the submission content for the HGR export license is summarized in the Specimen Import & Export section.

Ethics Committee Requirements

Each ethics committee (EC) has its own application form and clearance requirements that can differ significantly regarding the number of copies to be supplied and application format requirements.

The following list was compiled from the Measures-Ethics and the RegEthics to exemplify the common elements shared by the various application forms (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

• Application for Human Research Ethics Review (See CHN-27 for a sample institutional application)
• Application Protocol for Results of Research or Related Technologies
• Protocol
• Sample ICF (See Children/Minors section for additional information)
• Case Report Form
• Principal investigator(s) CV(s)
• NMPA approval letter
• Certificate of Analysis for the drug issued by the National Institutes for Food and Drug Control (NIFDC) or corresponding provincial, autonomous region, or municipal institutes
• IB
• Any additional feedback from other ECs participating on the protocol
• Statement of planned tasks
• Letter of intention for cooperation
• Letter of commitment on the reliability of research materials
• Scientific opinions
• Statement of no conflict of interest
• Proof of the source of biological samples and information data
• Site list
• Site profile(s)
• Product literature
• Insurance policy (if any)
• Materials provided to participants
• Information on the lead research investigator; the legal qualification certificate of the institution; and the source of research funding
• Recruitment advertisements and their release forms
• An explanation of the form of publication of research results
• Other relevant materials that the EC believes need to be submitted

Clinical Protocol

As delineated in the NMPA-GCP-No57-2020 and the ICH’s Guideline for Good Clinical Practice E6(R2) (CHN-37), the clinical protocol should include the following elements (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

• General information
• Background information
• Trial topic, purpose(s), and objective(s)
• Sponsor name and address
• Trial site location
• Principal investigator(s) name(s), qualification(s), and address(es)
• Trial design, random selection method, and blinding level
• Inclusion criteria; participant treatment, inclusion, exclusion, and release procedures; and method of grouping participants
• Form, dosage, route, method, and frequency of administration; treatment period; usage order of concomitant medicines; and packaging and labeling description
• Investigational product registration, usage record, delivery, handling and storage conditions (See Investigational Products topic for detailed coverage of this subject)
• Efficacy assessment
• Safety assessment
• Statistics
• Direct access to source data/documents
• Quality control/quality assurance
• Ethics
• Data handling/recordkeeping
• Financing/insurance
• Clinical observations, on-site visits, and measures to ensure the participant’s compliance with trial procedures
• Rules regarding clinical trial termination and completion
• Adverse event recording requirements, and serious adverse event reporting methods (See Safety Reporting section for additional information)
• Proposed trial schedule and completion date
• Publication policy

For complete protocol requirements, please refer to Chapter 6 of the NMPA-GCP-No57-2020 and Section 6 of CHN-37.

Regulatory Authority Requirements

Pharmacy and Poisons Board

As per the CTRules, the G-KenyaCT, and KEN-34, the following documentation must be submitted (signed, dated, and version referenced) to the Pharmacy and Poisons Board (PPB) (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

• Cover letter
• Study protocol
• Proof of study registration in the Pan African Clinical Trials Registry (KEN-19)
• Patient information leaflet and informed consent form (ICF)
• Investigators brochure (IB) and package inserts
• Investigational Medicinal Product Dossier (IMPD), including stability data for the investigational product (IP)
• Adequate data and information on previous studies and phases to support the current study
• Good manufacturing practice (GMP) certificate of the IP from the site of manufacture issued by a competent health authority in the manufacturer’s jurisdiction of origin
• Certificate of analysis of the IP
• Pictorial sample of the IPs, including the labeling text
• Signed investigator(s) curriculum vitae(s) (CV(s)), including that of the study pharmacist (the CV should include the current workload of the principal investigator (PI))
• Evidence of contractual agreement between the relevant parties
• Evidence of recent good clinical practice (GCP) training of the core study staff
• Data and Safety Monitoring Board (DSMB) information, including the charter, composition, and meeting schedule
• Detailed study budget
• Financial declaration by the sponsor and PI (KEN-2 and Annex 5 of the G-KenyaCT)
• No conflict of interest declaration by the sponsor and PI
• Signed declarations by the sponsor, PI, and the monitor that the study will be carried out according to the protocol and applicable laws, regulations, and GCP requirements (KEN-1 and Annex 4 of the G-KenyaCT)
• Indemnity cover for PI, investigators, and study pharmacist
• Clinical trials insurance cover for the study participants
• Copy of favorable opinion letter from local ethics committee (EC)
• Copy of current practice licenses for the investigators and study pharmacist
• Copy of approval letter(s) from collaborating institutions or other regulatory authorities, if applicable
• For multicenter/multi-site studies, an addendum for each of the proposed sites including, among other things, the sites’ capacity to carry out the study (e.g., personnel, equipment, laboratory)
• A signed statement by the applicant indicating that all information contained in, or referenced by, the application is complete and accurate, and is not false or misleading (Annex 4 of the G-KenyaCT)
• Payment of fees
• Statistical analysis plan
• A signed checklist (KEN-34 and Annex 2 of the G-KenyaCT)

Per the G-KenyaCT, a request for approval of an amendment must include a summary of the proposed amendments; the reason for the amendment; the impact of the amendment on the original study objectives; the impact of the amendments on the study endpoints and data generated; and the impact of the proposed amendments on the safety and wellbeing of study participants.

KEN-35 describes the submission content for requesting annual approval from the PPB.

National Commission for Science, Technology and Innovation

Per the STI-Regs and KEN-31, non-Kenyan applicants must be affiliated with a Kenyan institution. Per KEN-31, applicants must apply online through National Commission for Science, Technology and Innovation (NACOSTI)’s Research Information Management System (RIMS) website (KEN-24) and upload the following:

• Passport size color photo in JPG or PNG format
• Scanned ID/passport in PDF format
• Introductory letter from relevant institution signed by an authorized officer
• Affiliation letter from relevant local institution for foreigners signed by an authorized officer and valid for one (1) year
• Grant letter from the funding agency to support the amount indicated to fund the research
• PPB clinical trial approval
• Prior Informed Consent (PIC), Mutually Agreed Terms (MAT), or Material Transfer Agreement (MTA) where applicable, for applications to conduct research on genetic resources and derivatives
• Approved research proposal in PDF format
• Certificate of ethical clearance of the research (see list of accredited ECs in KEN-25)
• Evidence of payment as the last page of the uploaded proposal

Per KEN-31, the following conditions apply to the research license:

• The research license is valid for the proposed research, site, and specified period
• Both the research license and any rights thereunder are non-transferable
• NACOSTI may monitor and evaluate the research
• The licensee must inform the relevant County Director of Education, County Commissioner, and County Governor before research commencement
• Excavation, filming, and collection of specimens are subject to further permissions from relevant government agencies
• The research license does not give authority to transfer research materials
• The licensee shall submit one (1) hard copy and upload a soft copy of their final report within one (1) year of completion of the research
• NACOSTI reserves the right to modify the conditions of the research license including its cancellation without prior notice

KEN-31 states that if the research is not completed within the stipulated period, the applicant may apply for renewal of the research license and pay the requisite fee. A progress report should be submitted with the request for renewal instead of a proposal. The progress report must indicate the objectives and activities that have been accomplished, as well as the research work that has yet to be undertaken. KEN-31 further indicates that submissions requesting renewal should be made at least 30 days prior to the expiration of the approval period.

Ethics Committee Requirements

EC requirements vary depending on the specific EC. See KEN-17 and KEN-26 for examples of accredited EC submission and review guidelines.

As set forth in the G-ECBiomedRes, a foreign sponsoring agency must also submit its research protocol for ethics review according to its own country’s standards. This research must be responsive to the health needs of Kenya and reasonably accessible to the community in which the research was conducted.

Clinical Protocol

Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14). The CTRules the G-KenyaCT, the G-ECBiomedRes, and KEN-14 outline the key elements of a research protocol in Kenya (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

• A project title that adequately captures the essence of the study
• The names, addresses, signatures, and updated abridged curriculum vitae of the investigators
• Evidence that the PI has prior training in GCP
• Contact information for the EC and collaborating institutions
• A summary of the project
• Introduction, background, and literature review, including nonclinical data
• Study objectives, rationale, questions, and hypothesis/es
• Study site, design, and methodology
• Ethical considerations
• Role of investigators
• Schedule
• References
• Budget
• Publication policy
• Consent explanation - elements of consent explanations
• ICF with signature provisions for participants and the PIs
• Risks and benefits
• Mode of assessment of the safety and efficacy of the IP
• Mode of collecting, analyzing, and reporting the statistics of the clinical trial
• Source data documents of the clinical trial
• Quality control and quality assurance
• Confidentiality
• Recruitment, selection, treatment, and withdrawal of participants
• Compensation and post-trial access program
• Undue inducement and coercion
• Voluntariness
• Alternative treatment(s) if available
• Storage of specimens
• MTA, where applicable
• Data management and statistical analysis

In addition, per the G-KenyaCT, the protocol should have a clear description of study stoppage rules indicating reasons, who makes the decision, and how the decision will be communicated to the PPB and the EC.

Overview

As stated in the DRR, ethics committee (EC) review may be submitted parallel to the National Medical Products Administration (NMPA) review, but the study cannot be initiated until after review and approval by the EC.

Per the NHC-HGRmgt, the National Health Commission (NHC) is responsible for China’s management of human genetic resources (HGR). (Note that per SC-Order777 and NHC-HGRmgt, management of HGR was transferred from the Ministry of Science and Technology (MOST) to NHC, effective May 1, 2024). The Bioscrty-Law, the MgmtHumanGen, and the Rules-MgmtHGR, delineate that MOST (now the NHC) is responsible for China's management of HGR, which includes reviewing and approving research. Per the Rules-MgmtHGR, the collection, preservation, use, and external provision of China’s HGR must comply with ethical principles and pass the ethics review of ECs that have been registered with the relevant management departments. As part of the application filing for international cooperative clinical trials, NMPA approvals, notices, and/or filing registration must be obtained in advance. In addition, EC approvals must be submitted with the filing, so therefore cannot occur in parallel. (Please note that SC-Order777 amends the MgmtHumanGen to reflect the transfer of HGR management from MOST to the NHC, but the Bioscrty-Law and the Rules-MgmtHGR have not been amended to show the transfer.)

Regulatory Authority Approval

National Medical Products Administration

Per the DRR, upon application submittal, the NMPA will complete the administrative examination for completeness within five (5) days of receiving the application, and issue a notice of acceptance. If the application does not meet the technical requirements for review, the NMPA will notify the applicant, who must submit the additional information within five (5) days of the notice. According to CHN-14, the NMPA will process clinical trial applications within five (5) working days if the study falls within the scope of its authority; the application materials are complete and comply with the legally-prescribed format; and the applicant submits all supplementary application materials in accordance with the NMPA’s requirements. Per the DRR, the NMPA-No50-2018, and CHN-14, a clinical trial application will be considered approved after 60 working days if the applicant does not receive a rejection or an inquiry for clarification from the NMPA. These procedures do not apply in every situation and additional reforms are provided below.

The DRR indicates that the following is not included in the above time limits:

• Time taken by the applicant for supplementary information, rectification after verification, and verification of production processes, quality standards, and instructions as required
• Delays in the time of verification, inspection, and expert consultation meetings
• If the review and approval procedure is suspended, the time occupied during the period of suspension of the review and approval procedure
• Time taken by the initiation of overseas verification

The application review by the Center for Drug Evaluation (CDE) and inspections and testing by National Institutes for Food and Drug Control (NIFDC) can affect the timeline beyond 60 days, as needed. The CDE conducts technical reviews and the NIFDC tests drug samples. The NMPA-No51-2023 specifies that if necessary, an expert consultation meeting may be held. For clinical trials that are approved after review, the technical review team’s conclusion and associated "Clinical Trial Approval Notice" must clearly state the indications, clinical trial protocol title, number, version number, version date, etc. The review team’s conclusion and notice may propose revisions or suggestions to the clinical trial protocol if necessary. For clinical trial protocols that require revisions, CDE will notify the applicant through a professional inquiry letter, clearly informing the applicant of the problems and revision opinions in the current protocol. The applicant must submit a revised clinical trial protocol within five (5) days, following the guidance in the Prcdrs-Changes.

According to the NMPA-No82-2020, the NMPA timelines for review and decisions for expedited applications are as follows: The CDE will review the application for breakthrough drug procedures submitted by the applicant and, if necessary, organize an expert advisory committee for demonstration. The CDE must report the review results to the applicant within 45 days after receiving the application. If it is necessary to extend the review time limit, the extended time limit must not exceed one-half of the original review time limit. The CDE must publicize the specific information and reasons for the types of drugs to be included in the breakthrough therapy program, including the name of the drug, the applicant, the proposed indication (or functional indication), the application date, and the reason for the proposed inclusion. If there is no objection within five (5) days of the public announcement, it will be included in the breakthrough treatment drug program; if an objection is raised against the publicly announced product, a written opinion must be submitted to the CDE within five (5) days; the CDE must organize another review and make a decision within 15 days and notify all relevant parties.

Per the NMPA-No79-2018, for applications to conduct clinical trials with drugs treating rare diseases with urgently needed drugs already on the market in the United States, Europe, and Japan in the past decade, the CDE completes the technical review within three (3) months after acceptance; for other overseas new drugs, the technical review is completed within six (6) months after acceptance.

The NMPA-No21-2024 describes NMPA’s pilot work plan for optimizing the review and approval of clinical trials for innovative drugs. This initiative aims to review and approve innovative drug clinical trial applications within 30 business days (a reduction from the 60 days as described above in the normal procedures). The applicant must initiate the clinical trial within 12 weeks after the approval of the clinical trial application. The pilot work will last for one (1) year and the experience of the pilot work will be summarized in July 2025. For application and eligibility details see NMPA-No21-2024 and Scope of Assessment section.

For additional details on other expedited review pathways, see the Scope of Assessment section.

National Health Commission

Per the HGR-AppGuide, for HGR license applications, the NHC will pre-screen the electronic application to ensure it is complete. If the application does not pass, then the applicant will have one (1) opportunity to correct the submission. Per Rules-MgmtHGR, MOST (now the NHC) must make an administrative licensing decision on HGR license applications within 20 working days of acceptance. HGR-AppGuide reiterates the 20 working-day deadline by NHC, the agency currently authorized to approve HGC licenses. The Rules-MgmtHGR states that where an administrative licensing decision cannot be made within 20 working days, it may be extended by 10 working days with the approval of MOST (now the NHC), and the reason for the extension must be notified to the applicant. If it is necessary to conduct hearings, inspections, testing, quarantine, appraisals, and technical reviews, this additional time required must not be counted within the time limit, and the applicant must be notified in writing of the required time.

Ethics Committee Approval

In accordance with the Measures-Ethics, the EC must carry out an ethics review and issue its opinion within 30 days of acceptance. In urgent situations, an ethics review must be promptly carried out. In the case of emergencies such as outbreaks, ethics reviews and review opinions are generally carried out within 72 hours, and the requirements and quality of ethics reviews must not be reduced. Per the NMPA-GCP-No57-2020 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CHN-37), the institutional EC should review a proposed clinical trial within a reasonable time. The EC’s recommendations should be issued in writing and should indicate an approval; an approval after necessary modifications have been made; a disapproval; or a decision to terminate or suspend an already approved trial.

Overview

Based on the CTRules and the G-KenyaCT, the Pharmacy and Poisons Board (PPB)'s review and approval of an application to conduct a clinical trial is dependent upon obtaining ethics approval from a National Commission for Science, Technology and Innovation (NACOSTI)-accredited ethics committee (EC). Therefore, the PPB and EC reviews may not be conducted in parallel. In addition, the STI-Act and KEN-31 specify that all applicants must obtain a research license from NACOSTI prior to initiating a study.

Regulatory Authority Approval

Pharmacy and Poisons Board

Per the G-KenyaCT, sponsors (or applicants) can request pre-submission meetings to discuss pertinent issues prior to making a formal submission. The request must be made via the PPB online system (KEN-16) or in an official letter addressed to the Chief Executive Officer of the PPB and sent to admin@pharmacyboardkenya.org and copied to cta@pharmacyboardkenya.org. The request for a meeting should propose two (2) different dates for the meeting with the proposed dates being at least three (3) weeks away. (See Submission Process section for details on the content of request.)

Per the G-KenyaCT, upon receipt of a clinical trial application, the PPB’s Clinical Trial Division of the Product Safety Department screens the application package for completeness, which takes five (5) days. If accepted, an automatic system-generated reference number will be issued for each application. If additional information is needed, the sponsor will have 10 days to respond. The PPB aims to respond to applications within 30 working days. The sponsor or the representative must reference the PPB/Expert Committee on Clinical Trials (ECCT) number in all future application-related correspondence. The application is then evaluated by the ECCT and PPB staff according to their respective standard operating procedures. The PPB/ECCT’s decision to approve, request additional information, or reject the application is communicated to the sponsor or the representative in writing within 30 days of receiving a valid application. If additional information is requested, the sponsor has 90 days to respond after which the PPB has 15 days to issue a final decision. In certain cases, the PPB may refer the application to external experts for their recommendation.

Per the G-KenyaCT, the sponsor or the representative is also required to request approval annually from the PPB at least six (6) weeks prior to the expiration of the previous approval. Refer to the Checklist for Submitting a Request for Annual Approval (KEN-35) for relevant documentation requirements.

National Commission for Science, Technology and Innovation

Per KEN-5 and KEN-31, the timeline for NACOSTI’s license application process is 30 days.

KEN-31 states that if a research license application does not meet the conditions required under the STI-Act, NACOSTI must reject the application and communicate the reasons to the applicant. Any person may appeal NACOSTI’s decision to the Cabinet Secretary within 30 days of being notified of the decision.

Ethics Committee Approval

The EC review and approval process timeline will vary by institution.

Overview

Per the DRR, clinical trials must be conducted in institutions conducting drug clinical trials that comply with relevant regulations, and abide by the NMPA-GCP-No57-2020, including written approval from the ethics committee (EC) to the researcher before clinical trial implementation. Further, clinical trials of vaccines must be implemented or organized by China’s designated three-level medical institutions or disease prevention and control institutions at or above the provincial level that meet the prescribed conditions.

Per the NHC-HGRmgt, the National Health Commission (NHC) is responsible for China’s management of human genetic resources (HGR). (Note that per SC-Order777 and NHC-HGRmgt, management of HGR was transferred from the Ministry of Science and Technology (MOST) to NHC, effective May 1, 2024). The Bioscrty-Law, the MgmtHumanGen, and the Rules-MgmtHGR delineate that MOST (now the NHC) is responsible for China's management of HGR, which includes reviewing and approving research before initiation. Per the Rules-MgmtHGR, clinical trials involving the collection, preservation, use, and export of China’s HGR must be approved by ECs in the relevant institutions. Further, applications for administrative licenses for international cooperation clinical trials (without exports) using HGR must pass an ethics review in the partner countries and be filed with MOST (now the NHC) before initiating the study. The Rules-MgmtHGR also state that clinical trial applications must pass a security review organized by MOST (now the NHC) if the study’s provision or opening of HGR information to foreign entities may impact China’s public health, national security, or the social public interest.

Clinical Trial Agreement

As delineated in the NMPA-GCP-No57-2020 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CHN-37), the sponsor must sign an agreement or contract with the participating institution(s). The NMPA-GCP-No57-2020 also states that before the trial begins, the sponsor and the investigator must sign a written agreement regarding the trial protocol, monitoring, auditing, and standard operating procedures, as well as each party’s responsibilities during the trial.

Per the NMPA-GCP-No57-2020, the agreement must include the following elements:

• Compliance with this specification and relevant clinical trial laws and regulations during the implementation of clinical trials
• Implementation of the trial protocol agreed to by the sponsor and investigator, and approved by the EC
• Compliance with data recording and reporting procedures
• Consent to supervision and inspection
• Retention period of necessary documents related to clinical trials
• The agreement on publishing articles and intellectual property rights

Clinical Trial Registration

Per the DRR, the sponsor must register the drug clinical trial plan and other information on the drug clinical trial registration and information disclosure platform before launching the drug clinical trial. The NMPA-No9-2020 requires the National Medical Products Administration (NMPA)'s Center for Drug Evaluation (CDE) to establish and maintain this registry (CHN-53). Before starting a clinical trial, the clinical trial information must be registered in any of these situations:

• The clinical trial has been approved by the NMPA
• The clinical trial of a chemical drug bioequivalence test was recorded and the record number obtained
• Phase IV clinical trials and post-marketing studies were conducted in accordance with the requirements of the drug registration certificate or NMPA notice
• Other situations required for registration according to the NMPA

Also see the handling guideline for clinical trial registration (CHN-13) for more information and frequently asked questions.

Governance

Pursuant to the NHC-ClinProjMgmt, medical institutions must develop internal rules and standard operating procedures (SOPs) for administering clinical studies; centralize financial management of clinical study projects; and maintain a project-based approval system and supervision throughout the study process. In addition to having an EC, medical institutions must also establish a Clinical Study Administration Committee and a subordinate body, and a Clinical Study Administration Division to handle daily project administration. For detailed requirements, see the NHC-ClinProjMgmt.

Overview

In accordance with the PPA, the STI-Act, the G-KenyaCT, the G-ECBiomedRes, KEN-21, and KEN-16, a clinical trial can only commence after the sponsor or the representative receives authorization from Kenya’s Pharmacy and Poisons Board (PPB), and ethics committee (EC) approval from an institutional EC that has been accredited by the National Commission for Science, Technology and Innovation (NACOSTI) prior to initiating a study. ECs are accredited pursuant to the requirements delineated in the G-ECAccred. The G-KenyaCT specifies that the PPB review and approval process may not be conducted in parallel with the EC review. In addition, the STI-Act and KEN-31 state that all applicants must obtain a research license from NACOSTI prior to initiating a study. No waiting period is required following the applicant’s receipt of these approvals. Regarding notifications, KEN-31 requires the licensee to inform the relevant County Director of Education, County Commissioner, and County Governor before commencement of the research. Further, the licensee must disclose to NACOSTI, the institutional ECs, and the relevant national agencies any findings that are of national strategic importance.

As per the PPA and the G-KenyaCT, the sponsor or the representative is required to obtain an import license for the shipment of an investigational product to be used in the trial. (See the Manufacturing & Import section for additional information).

As stated in the G-KenyaCT, Kenyan clinical trials should be conducted in compliance with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (KEN-14).

Clinical Trial Agreement

Prior to initiating the trial, the G-KenyaCT requires that the sponsor agree with investigator(s) on the definition, establishment, and assignment of responsibilities specified in the protocol. These responsibilities include conduct of the trial in compliance with KEN-14 and the approved protocol; data management; unblinding of treatment codes; statistical considerations; and preparation of the final clinical report. The sponsor, in a written document, may agree to transfer all related activities of the clinical trial to designated research institutions. However, all responsibility for the trial lies with the sponsor. Prior to the initiation of the clinical trial, the agreement between the sponsor and investigators should be in writing as part of the protocol submitted for PPB approval or in a separate agreement. The sponsor and investigators must sign and date the protocol of the trial to confirm the agreement.

Clinical Trial Registration

As per the G-KenyaCT, all clinical trials taking place in Kenya must be registered in the PPB’s Online Clinical Trials Registry System (KEN-16). The principal investigator is required to log in and set up an account to register a study.

In addition, as required by KEN-34, all clinical trials taking place in Kenya must be registered in the Pan African Clinical Trials Registry (KEN-19).

Safety Reporting Definitions

In accordance with the NMPA-GCP-No57-2020, the following definitions provide a basis for a common understanding of China’s safety reporting requirements:

• Adverse Event (AE) – All adverse medical events that occur after participants receive the experimental drugs. They can be manifested as symptoms and signs, diseases, or abnormal laboratory tests, but they may not be causally related to the experimental drugs
• Serious Adverse Event (SAE) – Any untoward medical occurrence that at any dose: results in death, is life threatening, requires hospitalization, results in persistent or significant disability or incapacity, or causes a congenital anomaly/birth defect after the participant receives the experimental drug during a clinical trial
• Adverse Drug Reaction (ADR) – Any adverse or undesired reactions that may be related to the experimental drugs that occur during clinical trials. There is at least a reasonable possibility of the causal relationship between the experimental drug and the adverse event (i.e., the correlation cannot be ruled out)
• Suspicious and Unexpected Serious Adverse Reactions (SUSAR) – Suspicious and unexpected serious clinical manifestations that exceed the existing information, such as the Investigator's Brochure (IB) of the trial drug, the instructions of the marketed drug, or the summary of product characteristics

In addition, the G-SftyRptStds includes “Serious Adverse Drug Reactions” (SADRs) as well as other important medical events, which require medical judgement to determine if measures are needed to prevent the occurrence of one (1) of the preceding.

See the NMPA-No31-2024 for NMPA’s guidance on evaluating the correlation between AEs and drugs used in clinical trials.

Safety Reporting Requirements

Investigator Responsibilities

Per the NMPA-GCP-No57-2020, the investigator should immediately report all SAEs in writing to the sponsor, and then provide a detailed and written follow-up report in a timely manner. However, this does not include SAEs that do not need to be reported immediately per the trial protocol or other documents (such as the investigator’s brochure). SAE reports and follow-up reports should indicate the participant’s identification code in the clinical trial, not the participant’s real name, citizenship number, and residential address. AEs and abnormal laboratory values that are important for the safety evaluation specified in the test plan must be reported to the sponsor in accordance with the requirements and time limit of the test plan. For reports involving deaths, the investigator should provide the sponsor and the ethics committee (EC) with other required information, such as autopsy reports and final medical reports.

The Measures-Ethics state that for research that has been approved for implementation, researchers must immediately report SAEs that occur during the research process to the EC. The EC must conduct a timely review to determine whether the measures taken by researchers to protect the personal safety and health rights and interests of research participants are adequate, reassess the risk-benefit ratio of the research, and issue review opinions.

Sponsor Responsibilities

Per the DRR, the sponsor must regularly submit a safety update report to the National Medical Products Administration (NMPA)'s Center for Drug Evaluation (CDE) via the Applicant’s Window (CHN-58). The safety update report during the research and development period should be submitted once a year, and within two (2) months after the full year following approval of the drug clinical trial. The CDE may require the sponsor to adjust the reporting cycle based on the review situation. Additional guidance on the safety update report is provided in the NMPA-No7-2020 and the NMPA-No65-2021. For international multicenter clinical trials, NMPA-No2-2015 states that sponsors should unify the collection and evaluation methods of AEs, use a unified glossary to code AEs, and establish a unified safety database for the collection and evaluation of SAEs. AE or SAE reports should comply with the relevant national and regional requirements.

The DRR requires the sponsor to report SUSARs and other potentially serious safety risks to the CDE in a timely manner in accordance with relevant requirements. The NMPA-GCP-No57-2020 and the G-SftyRptStds specify that the sponsor is responsible for the safety assessment of the drugs during the trial period. The G-SftyRptStds and the NMPA-No65-2021 state that during the clinical trial, the sponsor judges whether SUSARs are related to the drug. When the sponsor and the investigator cannot agree on the causal relationship between the AE and the drug, the experimental drug should not be ruled out and it must be reported. Also see NMPA-No102-2019 for guidelines on classifying AEs in clinical trials of investigational vaccines.

The NMPA-No16-2023 and the NMPA-No5-2020 state that a sound pharmacovigilance system should be established to monitor safety risks during drug clinical trials, which should include comprehensive drug data collection and risk monitoring, identification, assessment, and control. In addition, safety problems and risks should be discovered in a timely manner, and necessary risk management measures should be taken proactively, such as adjusting clinical trial plans, and suspending or terminating clinical trials, etc. The NMPA-No5-2020 provides guidance on evaluating and managing safety issues and requires sponsors to actively cooperate with clinical trial institutions and other relevant parties to strictly implement the main responsibility of safety risk management.

The NMPA-GCP-No57-2020 requires the sponsor to promptly notify the investigator, the clinical trial institution, and the drug regulatory authority of issues discovered in the clinical trial that may affect the safety of participants, the implementation of the clinical trial, and the consent of the ECs. Further, the sponsor must promptly report SUSARs to all participating investigators, clinical trial institutions, and ECs; sponsors must also report SUSARs to drug regulatory and health authorities. The NMPA-GCP-No57-2020 states that after receiving safety information from the sponsor, the investigator should sign the documentation and consider whether to treat the participant and make corresponding adjustments to the protocol.

The NMPA-No65-2021 and the G-SftyRptStds specify reporting timelines for unexpected death or serious life-threatening adverse reactions. The sponsor must submit the report as soon as possible after first learned, but not more than seven (7) days; and detailed follow-up information should be submitted within the next eight (8) days. For SUSARs, the report should be submitted as soon as possible after the first notification, but not more than 15 days. In addition to individual SUSAR reports, other potentially serious safety risk information should be reported to the CDE as soon as possible, and medical treatments should be decided upon for each situation. Generally, information that significantly affects the evaluation of the drug’s risks and benefits, changes in drug usage, or information that affects the overall drug development process, falls into this category. Domestic and foreign safety reports should be reported in Chinese. Further, the DAL states that if there is a safety problem or risk during the clinical trial, the sponsor must adjust the clinical trial plan, suspend or terminate the clinical trial, and report the issue to the NMPA.

See NMPA-No60-2021 for guidance on writing safety reference information in the investigator’s manual.

Form Completion & Delivery Requirements

As per the NMPA-No50-2018, the NMPA-No10-2018, and the G-SftyRptStds, investigators must comply with the rapid reporting requirements in the International Council for Harmonisation (ICH)’s E2A Guideline, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (CHN-39), and ICH E2B(R3), Electronic Transmission of Individual Case Safety Reports (CHN-40). As indicated in the G-SftyRptStds, all SUSARs from clinical trials should be reported in compliance with E2A and E2B(R3). To comply with these requirements, the project’s electronic safety database must meet the E2B(R3)’s XML format and be submitted to the CDE in Chinese (CHN-58). Potentially serious security risks can be sent as a “Quick Report” through e-mail to: lcqjywjj@cde.org.cn. See NMPA-No17-2023 for frequently asked questions and answers related to rapid safety reporting. Additional questions pertaining to rapid reporting can be sent to ywjjxtwt@cde.org.cn.

According to the NMPA-No230-2015, in clinical trials of new drugs, which now only require a one-time approval, after the completion of Phase I and Phase II trials, the applicant should submit all test results and demonstrate that no safety problems were found before beginning the next phase of the trial. Furthermore, NMPA-No230-2015 states that the applicant must submit all adverse event data on time.

Safety Reporting Definitions

According to the CTRules and the G-KenyaCT, the following definitions provide a basis for a common understanding of Kenya’s safety reporting requirements:

• Adverse Event (or Adverse Experience) (AE) – Any untoward medical occurrence in a participant in a clinical investigation study or intervention product, and which does not necessarily have a causal relationship with the treatment
• Adverse Drug Reaction (ADR) – All noxious and unintended responses to a clinical trial study or interventional product related to any dose or all unintended noxious responses to a registered medicinal product which occurs at doses normally used in humans for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function
• Serious Adverse Event (SAE) – Any untoward medical occurrence that at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
• Suspected Unexpected Serious Adverse Reaction (SUSAR) – A serious adverse reaction that is not identified in practice, severity, or frequency by the referenced safety information

Safety Reporting Requirements

Investigator Responsibilities

Per G-KenyaCT, the investigator must ensure that all SAEs are reported promptly to Kenya’s Pharmacy and Poisons Board (PPB) within the mandated timelines, as described below. Proper protection procedures or treatments should be administered to trial participants with SAEs.

Sponsor Responsibilities

As indicated in the CTRules and the G-KenyaCT, the sponsor should report to the PPB and all relevant institutions, all SAEs and SUSARs occurring during the course of the trial. The G-KenyaCT specifies that the sponsor should expedite reporting all SAEs to the PPB and the ethics committee (EC), and the sponsor and investigators should immediately undertake appropriate and necessary measures and treatment to protect the trial participants. The CTRules delineates that where a sponsor conducts a clinical trial on the same health product or active pharmaceutical substance in another country, the sponsor must submit a report of any SUSAR or SAE that occurs in the other clinical trial to the PPB. Per the CTRules and the G-KenyaCT, a sponsor must submit an initial report of an fatal or life-threatening SUSAR or SAE as soon as it occurs but, in any case, not later than seven (7) days after the occurrence of the event. The G-KenyaCT indicates that if the initial report is incomplete, the sponsor must submit a completed report based on the initial information within an additional eight (8) days. As required in the CTRules and the G-KenyaCT, a report of the occurrence of a SUSAR or SAE must specify whether the SUSAR or SAE is related to the clinical trial.

As indicated in the CTRules and the G-KenyaCT, other important considerations and timelines include the following (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

• The sponsor must notify all the investigators involved in ongoing clinical trials of the investigational product (IP) of all SAEs and SUSARs within 15 calendar days
• Any IP-related SAE must receive immediate medical attention and be reported to the PPB
• The SAE report form must be completed (including lab results) and submitted to enable causality assessment
• All fatal cases must be accompanied by a formal autopsy report, and a verbal autopsy report should be submitted in those exceptional cases where a formal autopsy is not possible
• Any frequent IP related AE/ADR must receive immediate medical attention and be reported to the PPB within seven (7) days
• The sponsor must submit a report on a SUSAR that is not fatal or life-threatening within 15 days after the occurrence of the event
• The principal investigator (PI) is required to submit follow-up information as soon as it becomes available
• All additional information should be clearly marked as updated and must include the Protocol Number and Participant Number
• Foreign regulatory decisions that affect the safety or use of the product under study must be reported to the PPB within seven (7) days through a detailed report
• Literature reports that have implications for the safety of the IP must be submitted within 15 days with a detailed report and a copy of the publication
• New information or notification of change in nature, severity, or frequency of risk factors for the product under study or conduct of trial must be submitted within 15 days

Other Safety Reports

The G-ECBiomedRes indicate that ECs should monitor research, and will report to the National Bioethics Committee upon notification of an AE.

The CTRules and the G-KenyaCT state that the sponsor must also submit a safety report to the PPB once a year throughout the clinical trial, or upon request. The purpose of the annual safety report is to briefly describe all new safety information relevant to one (1) or more clinical trial(s), and to assess the safety conditions of the participants enrolled in these trial(s). The safety report must include a log of SAE and SUSAR events. The SAE and SUSAR log should include the following:

• Patient Identification
• Age
• Date of recruitment into the study
• Type of SAE or SUSAR
• SAE or SUSAR start and end dates
• Reason for reporting the event as an SAE or SUSAR
• Relation to IP
• SAE or SUSAR outcome

Note that the PPB may require more frequent reporting of the safety reports depending on the nature of the clinical trial being implemented. When this is the case, the PPB must communicate the required frequency to the PI and sponsor in writing.

Form Completion & Delivery Requirements

As per the G-KenyaCT and KEN-16, all SAEs and SUSARs must be reported to the PPB via the Pharmacovigilance Electronic Reporting System (PvERS) (KEN-6).

Interim and Annual Progress Reports

The NMPA-GCP-No57-2020 and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CHN-37) require the investigator to submit an annual report on the clinical trial to the ethics committee (EC). In addition, the investigator must provide a progress report in accordance with requirements established by the EC. When there is a situation that significantly affects the implementation of clinical trials or increases the risks to participants, the investigator should report it in writing to the sponsor, the EC, and the clinical trial institution as soon as possible. The Measures-Ethics reiterates that the researcher must submit progress reports. The NMPA-No2-2015 requires sponsors and researchers to submit the progress of international multicenter clinical trials to the EC, including but not limited to enrollment, important decisions of the independent data supervision committee (if applicable), and safety information in their own countries and other countries/regions, so as to facilitate the EC’s understanding of the overall situation of the trial, conduct follow-up reviews, and protect the safety and rights of participants.

According to the NMPA-No230-2015, in clinical trials of new drugs, which now only require a one-time approval, after the completion of Phase I and Phase II trials, the applicant should submit all test results and demonstrate that no safety problems were found before beginning the next phase of the trial. Furthermore, NMPA-No230-2015 states that the applicant must submit an annual report on time.

CHN-37 states that the investigator should promptly provide written reports to the sponsor and the institutional EC on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants. In addition, the investigator should submit written summaries of the trial status to the institutional EC annually, or more frequently, if requested by the institutional EC. Per the Measures-Ethics researchers must promptly submit reports on suspension, termination, and completion to the EC.

Final Report

Per the NMPA-GCP-No57-2020, after the clinical trial is completed, the investigator must report to the clinical trial institution. The investigator must provide the EC with a summary of the clinical trial results and provide the sponsor with the clinical trial related reports required by the drug regulatory authority. Per the DRR, the sponsor must register clinical trial results on the Applicant’s Window (CHN-58).

Interim and Annual Progress Reports

As stated in the G-KenyaCT, the sponsor and/or the principal investigator (PI) is required to send progress reports to the Pharmacy and Poisons Board (PPB) on an annual basis, or as may be required, from the date of the trial’s initiation. The progress report should contain the following:

• Current status of the study
• Summary of the participants screened (e.g., failed screenings, participants enrolled, withdrawn, or lost to follow-up, and other challenges)
• Summary of protocol deviations and violations
• Updated investigational product Investigator’s Brochure
• Drug Safety Update Report
• Copy of the latest Data Safety Management Board report
• Copy of favorable opinion from the ethics committee (EC) on record
• Copy of annual practice license for the investigators and pharmacists
• Suspected, Unexpected, Serious Adverse Event (SUSAR) and Serious Adverse Event (SAE) Log

For multisite trials, per the G-KenyaCT, the sponsor or the representative must submit a summarized report for all of the sites and include the information listed above.

Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14). As per KEN-14, the investigator should promptly provide written reports to the sponsor and the institutional EC on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants.

According to the G-KenyaCT, for annual renewal of the study, the sponsor or the representative must submit a copy of the progress report including the documents listed above. The request must also be accompanied by copies of annual practice licenses for the investigators and pharmacists, and a copy of valid insurance coverage for the participants. All documents must be submitted using the PPB’s Online Clinical Trials Registry System (KEN-16). The sponsor or the representative must receive an acknowledgement of this submission before proceeding with the study. These documents must be submitted to the PPB at least six (6) weeks prior to the expiration of the previous approval.

Pursuant to KEN-14, the investigator should submit written summaries of the trial status to the institutional EC annually, or more frequently, if requested.

Final Report

Per the G-KenyaCT, the sponsor must notify the PPB of the end of a clinical trial taking place at a Kenyan site within 15 days. After the trial has been conducted and closed, the applicant must submit an executive summary report of the study within 30 days. This should be followed by a clinical study report within 180 days of the study closure unless otherwise justified. The report must comply with the International Council for Harmonisation's ICH E3 format (KEN-13). The report must include a short but comprehensive summary of the trial’s essential findings and methodology and should also contain a layman’s summary. Additionally, the sponsor must inform the PPB of any results that will be publicly released at least 14 days before release. In addition, upon completion of the trial, as delineated in KEN-14, the investigator is required to submit a final report to the institutional EC summarizing the trial’s outcome.

For multi-site research, the G-ECBiomedRes requires all parties to decide on procedures for drafting a common final report and publication at the onset of the research. Individual sites or institutions must not publish any data until the appropriate authorities accept the combined report.

KEN-31 further indicates that the research license applicant must submit one (1) hard copy and upload a soft copy of the final research report to the National Commission for Science, Technology and Innovation (NACOSTI) within one (1) year of the research’s completion.

As per the DRR, the NMPA-GCP-No57-2020, and the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (CHN-37), a sponsor is defined as a company, institution, or organization that initiates a clinical trial, and is responsible for managing, financing, and monitoring the trial. The DRR further specifies that the enterprise or institution applicant must be able to bear corresponding legal responsibilities. Per the DRR, applicants who are approved to carry out clinical trials of drugs are referred to as “sponsors” of clinical trials. If the sponsor changes, the changed sponsor must bear the relevant responsibilities and obligations of the drug clinical trial.

Per the NMPA-GCP-No57-2020 and CHN-37, a sponsor can authorize a contract research organization (CRO) to carry out certain work and obligations regarding the clinical trial. The sponsor can entrust part or all of the work and tasks of its clinical trial to the CRO, but the sponsor is still the ultimate person responsible for the quality and reliability of the clinical trial data and should supervise the various tasks undertaken by the CRO. The CRO must implement quality assurance and quality control measures. Any work entrusted by the sponsor to the CRO must be documented in a signed agreement. The sponsor is still responsible for work and tasks that are not clearly entrusted to the CRO. The requirements for sponsors in this specification apply to CROs that undertake the work and tasks related to sponsors.

A sponsor may be domestic or foreign; however, per the DRR and CHN-11, a Chinese legal entity must submit the clinical trial application.

Per the DAL, the sponsor is also referred to as the “holder” of the drug registration certificate, which is an entity that has obtained a drug registration certificate and includes institutions that are responsible for clinical trials. The legal representative and principal person holding the drug registration certificate is fully responsible for the quality of the drug used in a clinical trial. When the holder of the certificate is an overseas entity, their designated legal person in China must fulfill the same obligations as the holder of the drug registration certificate and bear joint and several liability with the holder of the drug registration certificate.

Definition of Foreign Entities in Regard to Collecting or Preserving Human Genetic Resources

For purposes of obtaining a human genetic resources (HGR) license, the HGR-AppGuide defines foreign entities as institutions established or actually controlled by overseas organizations or individuals including the following:

• A foreign organization or individual that holds or indirectly holds more than 50% of the shares, equity, voting rights, property shares, or other similar interests of an institution
• A foreign organization or individual that holds or indirectly holds less than 50% of the shares, equity, voting rights, property shares, or other similar rights and interests of the institution, but the voting rights or other rights and interests they enjoy are sufficient to control or exert significant influence on the decision-making, management, and other behaviors of the institution
• Foreign organizations or individuals, through investment relationships, agreements, or other arrangements, are able to control or exert significant influence on the decision-making, management, and other behaviors of the institution
• Other circumstances prescribed by laws, administrative regulations, and rules.

The HGR-AppGuide indicates that domestically-invested actual controlling institutions located in Hong Kong and Macao are regarded as Chinese units.

As per the G-KenyaCT, a sponsor is defined as an individual, a company, an institution, or an organization who takes legal responsibility for the initiation, management, and financing of a trial. According to the G-KenyaCT, a sponsor, in a written document, may agree to transfer all related activities of the clinical trial to designated research institutions. However, all responsibility for the trial lies with the sponsor. The G-ECBiomedRes indicates that sponsors may be foreign, but must comply with certain conditions including affiliating themselves to institutions recognized in Kenya.

Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14). In accordance with KEN-14, Kenya permits a sponsor to transfer any or all of its trial-related duties and functions to a contract research organization (CRO) and/or institutional site(s). However, the ultimate responsibility for the trial data’s quality and integrity always resides with the sponsor. Any trial-related responsibilities transferred to a CRO should be specified in a written agreement. The CRO should implement quality assurance and quality control.

Overview

Per the DRR, drug clinical trials must be conducted in institutions conducting drug clinical trials that comply with relevant regulations and abide by the clinical trial quality management standards. As set forth in the NMPA-GCP-No57-2020 and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (CHN-37), the sponsor is responsible for selecting the investigator(s) and institution(s) for the clinical trial, taking into account the appropriateness and availability of the study site and facilities. The sponsor must also ensure that the investigator(s) are qualified by training and experience. Prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor should provide the investigator(s) with the protocol and an investigator’s brochure (IB). Additionally, the sponsor must define and allocate all study related duties and responsibilities to the relevant parties participating in the study. Furthermore, the sponsor must sign an agreement or contract with the participating institution(s). The NMPA-GCP-No57-2020 indicates that for clinical trials involving multiple institutions, the sponsor must be responsible for selecting the team leader unit. (See the Submission Content section for additional information on clinical trial application requirements). See the NMPA-GCP-No57-2020 for additional details on investigator and clinical trial institution requirements.

The NMPA-GCP-No57-2020 states that investigators and clinical trial institutions must possess the appropriate qualifications, training, and experience to assume responsibility for the trial. Further, they must be familiar with the trial protocol, IB, and related materials and information provided by the sponsor. They must be familiar with and abide by clinical trial regulations and laws and keep an authorization form for the division of responsibilities signed by the investigator. Researchers and clinical trial institutions must accept the supervision and inspection organized by the sponsor as well as by the National Medical Products Administration (NMPA). In addition, with the sponsor’s consent, investigators and clinical trial institutions can authorize qualified individuals or units to undertake clinical trial-related responsibilities and functions.

With regard to institutions, the DRR further delineates that drug clinical trials must be conducted in institutions that have the corresponding required conditions and are registered. For example, vaccine clinical trials must be implemented or organized by China’s designated three-level medical institutions or disease prevention and control institutions at or above the provincial level that meet the required conditions.

Institutional Registration

Per the SC-Opinions-No42 and the NMPA-NHC-No101-2019, the NMPA adopted a registration system for institutions with qualifying conditions to be entrusted to conduct clinical trials and operate ethics committees (ECs). This reform eases institutional burdens by removing the pre-approval accreditation requirements. Among other conditions, the NMPA-NHC-No101-2019 specifies that an institution is entrusted to conduct clinical trials if the main investigators of clinical trials have senior professional titles and have participated in more than three (3) clinical trials. The main investigator must supervise the implementation of drug clinical trials and the performance of each researcher in the performance of their work duties and take measures to implement the quality management of drug clinical trials to ensure the reliability and accuracy of the data. Institutions conducting drug clinical trials must submit a work summary report of clinical trials in the previous year before January 31 of each year. NMPA-No1-2024 provides guidance and templates to institutions conducting drug clinical trials on filling out this annual work summary report. NMPA-NHC-No101-2019 indicates that the NMPA is establishing a record management information platform for the registration and operation management of institutions conducting drug clinical trials, as well as the supervision and inspection by drug regulatory agencies.

For additional details on the registration conditions, operations management, supervision, and inspection of institutions, see the NMPA-NHC-No101-2019. Also see CHN-12 for additional details on registering institutions to carry out clinical trials in China.

Foreign Sponsor Responsibilities

The DRR requires foreign applicants/sponsors to designate Chinese legal entities to handle relevant drug registration matters.

Per the NHC-HGRmgt, the National Health Commission (NHC) is responsible for China’s management of human genetic resources (HGR). (Note that per SC-Order777 and NHC-HGRmgt, management of HGR was transferred from the Ministry of Science and Technology (MOST) to NHC, effective May 1, 2024).

Per the Rules-MgmtHGR, when data or information on human genetic resources (HGR) is provided or made available for use by foreign organizations, individuals, and institutions, the Chinese entity must notify MOST (now the NHC) in advance and may be required to pass a security review. The notification must report on the following:

• The purpose and use of providing or opening up the use of China’s HGR information to foreign entities
• The HGR data and backup copy of the information
• The basic circumstances of the foreign entities receiving the HGR information
• Risk assessments for the protection of Chinese HGR to foreign entities

This notification is not required during international scientific research that is licensed/recorded, where the Chinese unit provides the foreign party with information on HGR generated by the cooperation, and if the international cooperation agreement has stipulated that it will be used by the two (2) partners.

Note, that the Rules-MgmtHGR adopts a broad definition of “foreign units” that includes foreign organizations and institutions, as well as entities established or under “actual control” by foreign entities or individuals. See the Rules-MgmtHGR and Rules-MgmtHGR-Interp for specific guidelines for determining actual control.

Data and Safety Monitoring Board

The NMPA-GCP-No57-2020, CHN-37, and the NMPA-No65-2021 recommend establishing a Data and Safety Monitoring Board (DSMB) to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial. The EC-Guide indicates that any DSMB reports should be submitted to the EC during follow-up reviews, if applicable.

As delineated in G-SftyRptStds and the NMPA-No65-2021, the sponsor should appoint fulltime staff to monitor clinical trial safety information and manage serious adverse event reporting. Relevant standard operating procedures should be established, and all relevant personnel should be trained. The sponsor is also responsible to ensure staff understand the latest security information, conduct timely risk assessments, provide relevant information to inform participants and interested parties, and quickly report unexpected serious adverse reactions. Annex 3 to NMPA-No50-2018 requires that application materials for Phase I clinical trials focus on participant safety and describe the establishment of a drug safety committee and a pharmacovigilance system based on the clinical trial protocol.

NMPA-No2-2015 states that in large-scale international multicenter drug clinical trials, the establishment of independent data monitoring committees and endpoint determination committees for key indicators is usually considered. For critical clinical trials with relatively large sample sizes and relatively long research times, especially those driven by clinical events, it is necessary to establish an independent data supervision committee and establish clear working mechanisms and procedures. NMPA recommends that for studies in which Chinese patients account for more than 2%, Chinese experts be included in the global core independent data monitoring board. For situations where human factors may affect the determination of research results, such as international multicenter drug clinical trials where imaging evaluation results are the key evaluation endpoints, it is necessary to establish a unified endpoint judgment committee for the main research indicators to uniformly conduct independent evaluation and judgment of the main research indicators.

Multicenter Studies

Per NMPA-No2-2015, for international multicenter drug clinical trials, sponsors should ensure that investigators have the qualifications and ability to undertake the clinical trial. Sponsors should provide unified training for researchers, including training on clinical trial protocols, standard operating procedures, test record forms, computer use, etc. The training should clearly explain and translate various definitions; unify diagnosis, efficacy, and safety evaluation indicators; and ensure the consistency of researchers' understanding of clinical trial protocols and evaluation of relevant indicators.

In accordance with the NMPA-GCP-No57-2020 and CHN-37, to carry out multicenter clinical trials, the sponsor must ensure that all centers participating in the clinical trial comply with the trial protocol. The NMPA-GCP-No57-2020 specifies additional sponsor requirements:

• Provide the same test plan to each center; each center must comply with the same unified evaluation standards for clinical and laboratory data and instructions for filling out the case report form (CRF)
• Ensure each center uses the same CRF to record the test data obtained in clinical trials
• Indicate in the trial protocol if the investigator needs to increase the collection of experimental data, and provide the investigator with an additional CRF
• Develop a written document clarifying the responsibilities of the investigators in each center before the start of the clinical trial
• Ensure communication among researchers in each center

The NMPA-No35-2017 delineates that researchers can conduct Phase I of multi-regional clinical trials (MRCT) of imported investigational new drugs and therapeutic biological products (excluding vaccines) simultaneously in China. Upon completion of a MRCT in China, the marketing application of the imported drug can be submitted immediately and should comply with the DRR. See Submission Content section.

Overview

The G-KenyaCT, which requires sponsors to follow the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14), states that the sponsor is responsible for selecting the investigator(s) and the institution(s) for the clinical trial and for ensuring that the investigator(s) are qualified by education, training, and experience.

Per the CTRules and the G-KenyaCT, investigators must also meet the following requirements (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

• Provide evidence of their qualifications and experience through an up-to-date curriculum vitae (CV)
• Have a current practice license from the relevant regulatory authority
• Be familiar with the characteristics and appropriate use of the investigational product (IP) as described in the protocol, current investigator’s brochure (IB), in the product information, and in other information sources
• Have a clear understanding and willingness to obey the ethical, good clinical practice (GCP) and legal requirements in the conduct of the trial
• Permit monitoring and auditing of the trial and inspection by the Pharmacy and Poisons Board (PPB) or appointed representatives
• Keep a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties
• The principal investigator (PI) must be an appropriately qualified and competent person having practical experience within the relevant professional area and who is responsible for the conduct of the clinical trial at a clinical site
• The PI must have a degree in medicine, pharmacy, pharmacology, toxicology, biochemistry, dentistry, or a related discipline from a university recognized in Kenya
• The PI must have a valid practice license from the relevant regulatory authority
• The PI must have a valid professional indemnity cover
• The PI must be a citizen of Kenya or a permanent resident in Kenya
• A PI must have had previous experience as a co-investigator in at least two (2) trials in the relevant professional area
• Have adequate time and resources to carry out the study (See Annex 6 of the G-KenyaCT for the PPB’s recommended format to document the investigator’s workload)

Further, the G-KenyaCT states that sponsors must ensure that investigators have had formal training in GCPs with proof that a GCP course was attended within the last two (2) years. If training has not been completed, it is the responsibility of the sponsor to organize this training prior to initiating the study. The investigators will need to provide evidence of having obtained this training. As delineated in KEN-14, prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor should provide the investigator(s) with the protocol and an IB. Furthermore, the sponsor must sign an agreement or contract with the participating institution(s). Additionally, the sponsor must define and allocate all study related duties and responsibilities to the relevant parties participating in the study. (See the Submission Content section for additional information on clinical trial application requirements.)

Institutional Registration

The STI-Act and the STI-Regs require research institutions to register with the National Commission for Science, Technology and Innovation (NACOSTI) and obtain a Certificate of Registration. For detailed guidance on the vetting and approval process, see the STI-Regs and the G-InstitutionRegistration.

Upon creating an account in NACOSTI’s Kenya National Research Information System (KENRIS) (KEN-23), research institutions can apply for new research institution registration, maintain/update data, and submit annual reports. The application for registration of research institutions is also provided in KEN-11, and the reporting tool for registered research institutions is provided in KEN-36.

Foreign Sponsor Responsibilities

The G-ECBiomedRes requires that with collaborative research projects, the collaborating investigators, institutions, and countries must function as equal partners with safeguards to avoid exploitation of local researchers and participants. An external sponsoring agency should submit the research protocol to their country’s EC, as well as the Kenyan EC where the research is to be conducted. Further, this research must be responsive to the health needs of Kenya and reasonably accessible to the community in which the research was conducted. Consideration should be given to the sponsoring agency agreeing to maintain health services and faculties established for the purposes of the study in Kenya after the research has been completed. Such collaborative research must have a local/Kenyan co-principal investigator.

Data and Safety Monitoring Board

The G-KenyaCT indicates that the PPB recommends establishing a Data and Safety Monitoring Board (DSMB) to monitor trials in the following types of studies:

• Where the endpoint is such that a highly favorable or unfavorable result, or even a finding of futility at an interim analysis, might ethically require the trial to be terminated early
• When there are safety concerns due to the use of a particularly invasive treatment
• Where there is prior information suggesting the possibility of serious toxicity with the study treatment
• Where the participants involved represent a vulnerable population (e.g., children, pregnant women, elderly, terminally ill, or mentally incapacitated)
• When the participants represent a population at higher risk of death or other serious outcomes
• When the study is large, of long duration, and multi-center

KEN-14 states that a DSMB may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Per the G-KenyaCT, the DSMB must provide the following documentation to the PPB:

• DSMB composition
• Copy of DSMB charter
• DSMB reports to be submitted to the PPB within two (2) weeks of its deliberations and in the request for annual approval

For multicenter trials, the G-ECBiomedRes requires that centralized data management and analysis should be planned as per G-WHO-DSMB.

Multicenter Studies

Per the G-KenyaCT, for multicenter studies in Kenya, the coordinating investigator should be a Kenyan resident and should assume full responsibility for the trial.

The G-ECBiomedRes requires that multicenter trials conducted simultaneously by several investigators at different sites follow the same protocol. Ideally, these trials should be initiated at the same time at all sites. The sponsor must provide the protocol to the investigators, who will accept the protocol in writing. If approved by the EC of the local host institution, the protocol may be modified to suit the local conditions. Meetings should be organized at the initial and intermediate stages of the trial to ensure uniform procedures at all sites. All sites and parties should also agree on procedures for publication of a final report. Research staff should receive training at every trial site on the uniform procedures. In addition, research staff at all sites should implement standard methods for recruitment and evaluation/monitoring of laboratory procedures and conduct of trial. There must be monitoring to ensure the sites are following the protocol, which must include measures to terminate the participation of some sites, if necessary. Finally, centralized data management and analysis should be planned as per G-WHO-DSMB.

Additional multicenter guidance is delineated in KEN-14:

• All investigators conduct the trial in strict compliance with the protocol agreed to by the sponsor, and, if required, by the PPB, and given EC approval
• The case report forms (CRFs) are designed to capture the required data at all multicenter trial sites
• Investigator responsibilities are documented prior to the start of the trial
• All investigators are given instructions on following the protocol, complying with a uniform set of standards to assess clinical and laboratory findings, and completing the CRFs
• Communication among investigators is facilitated

Insurance

As set forth in the NMPA-GCP-No57-2020, the sponsor is responsible for providing the investigator and clinical trial institution with legal and economic insurance or a guarantee related to the clinical trial, which must be compatible with the nature and degree of risk of the clinical trial. This insurance should not include damage caused by the investigator and the clinical trial institution itself. The International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (CHN-37) guides sponsors on providing insurance. See CHN-11 for an analysis of clinical trial insurance in China.

Per NMPA-No2-2015, for insurance provided by overseas insurance companies in international multicenter clinical trials, the sponsor should ensure that participants in China can effectively and fully claim compensation, and give priority to protecting the rights and interests of participants.

Compensation

Injury or Death

Per the Measures-Ethics, when research participants suffer research-related damages, they must receive timely and free treatment, and they must be compensated in accordance with laws and regulations and the agreement of both parties. In accordance with the NMPA-GCP-No57-2020 and the EC-Guide, the sponsor must take appropriate measures to ensure that the participants and researchers can be compensated. The sponsor must bear the costs of diagnosis and treatment for the damage or death of the participant related to the clinical trial, as well as the corresponding compensation. Further, the sponsor must provide free trial drugs to participants and pay for medical testing related to clinical trials.

In addition, CHN-37 provides guidance to sponsors on providing compensation to research participants in the event of trial-related injuries or death. The sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries.

Trial Participation

Per Measures-Ethics, research participants must not be charged research-related fees, and appropriate compensation must be given to the research participants for reasonable expenses incurred in the course of the research process.

Insurance

As set forth in the G-KenyaCT and the G-ECBiomedRes, the sponsor must provide insurance cover for the study participants and ensure that the clinical trial institution, contract research organization (CRO), and researchers have sufficient insurance cover for the clinical trial. Per the G-KenyaCT, the sponsor’s policies and procedures should address the treatment costs for trial participants in the event of trial-related injuries, and the sponsor should submit this information as part of the clinical trial application (see KEN-34). In addition, a no-fault insurance cover must be obtained for all controlled human infection studies. The International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14) guides sponsors on providing insurance. Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in KEN-14.

For all sponsor-initiated studies, insurance coverage must be provided by an insurer registered by Kenya’s Insurance Regulatory Authority (IRA), and a valid insurance certificate must be issued by the IRA prior to the trial’s initiation and cover the duration of the study. The insurance certificate must be submitted as evidence to the Pharmacy and Poisons Board (PPB). The certificate must be properly executed by an insurance company under a valid insurance policy which makes explicit reference to the proposed study. In addition, the policy must grant coverage for any participant injury that is causally linked to trial activities. The policy must also cover the investigator(s)’ and the sponsor(s)’ liability in the trial, without excluding any damage which may be attributed to negligence. Moreover, self-insurance of the participants by other entities, such as the National Health Insurance Fund, will not be sufficient.

Further, per the G-KenyaCT, the sponsor must ensure that the investigators and CROs have professional indemnity insurance coverage for the period of the trial. The host institution must also have in place sufficient insurance to meet the potential liability of its investigators, those acting on behalf of the investigators, and its research members.

Compensation

Injury or Death

As specified in the G-KenyaCT and the G-ECBiomedRes, the sponsor is responsible for providing compensation to research participants and/or their legal heirs in the event of trial-related injuries or death. Per the G-ECBiomedRes, participants are entitled to such financial or other assistance as would compensate them equitably for any temporary or permanent impairment or disability. In the case of adverse events, there should be proper assessment, evaluation, and compensation. The G-ECBiomedRes also indicates that when investigational vaccines contain active or live-attenuated micro-organisms, should participants in the control group contract the disease for which a vaccine is being tested, free treatment must be provided.

In addition, the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14) provides guidance for sponsors on providing compensation to research participants in the event of trial-related injuries or death. The sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries.

Trial Participation

The G-ECBiomedRes defines compensation to include offers to participants, monetary or otherwise, to offset the time and inconvenience for participating in research.

Post-Trial Access

Per the G-KenyaCT, the sponsor must put in place measures to ensure that the study participants have access to successful investigational products for their disease condition before the products have received a marketing authorization in Kenya, especially for the Phase III clinical trials. The G-ECBiomedRes indicates that when investigational vaccines contain active or live-attenuated micro-organisms, post-trial access to the vaccine should be available to the control group.

Quality Assurance/Quality Control

Per the DRR, the management of drugs used in clinical trials must comply with the clinical trial quality management regulations specified in NMPA-GCP-No57-2020. As stated in the NMPA-GCP-No57-2020 and the NMPA-No65-2021, the sponsor must establish quality control (QC) and quality assurance (QA) systems for the clinical trial. The NMPA-GCP-No57-2020 and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (CHN-37) specify that the quality management system for clinical trials should cover the entire process of clinical trials, including the design, implementation, recording, evaluation, result reports, and filing of clinical trials. NMPA-No65-2021 reiterates that sponsors must establish a quality management and pharmacovigilance system for investigational products (IPs). This system must collect safety information, monitor risk, identify and control safety problems in a timely manner, proactively take necessary risk control measures, and evaluate the effectiveness of risk control measures to protect participant safety.

Per the NMPA-GCP-No57-2020, quality management includes effective trial plan design, data collection methods and procedures, and information collection necessary for decision-making in clinical trials. The QA and QC methods for clinical trials should be consistent with the inherent risks of clinical trials and the importance of the information collected. Sponsors should ensure the operability of all aspects of clinical trials and avoid over-complication of trial procedures and data collection. The trial protocol, case report form (CRF), and other related documents should be clear, concise, and consistent. During an inspection by the National Medical Products Administration (NMPA), both the research and management teams should send personnel to participate.

The sponsor must conduct quality management based on risk. The key links and data that protect the rights and safety of participants and ensure the reliability of clinical trial results must be clearly defined when the sponsor formulates the trial plan. Risk should be considered from two (2) levels: 1) system level, such as facilities and equipment, standard operating procedures (SOPs), computerized systems, personnel, and suppliers; and 2) clinical trial level, such as trial drugs, trial design, data collection and recording, and the informed consent process. The risk assessment should consider the possibility of errors under existing risk control; the impact of the errors on the protection of participants’ rights and safety; and the extent to which the errors have been monitored. Control measures to reduce risks should be embodied in the design and implementation of the test plan, the monitoring plan, the contract with parties, SOPs, and various trainings. During clinical trials, quality management should be recorded and communicated with relevant parties in a timely manner to promote continuous improvement of risk assessment and quality. The sponsor must regularly evaluate the risk control measures based on new knowledge and experience during the clinical trial period to ensure the effectiveness and applicability of the current quality management. In addition, the sponsor’s quality management system must meet the following requirements:

• The sponsor is responsible for formulating, implementing, and updating the SOPs related to clinical trial QA and QC systems
• The entire process of clinical trials and laboratory testing must be carried out in strict accordance with the quality management SOPs, and each stage of data processing has QC to ensure that all data are reliable and the data processing process is correct
• The sponsor must sign a contract with all relevant parties, including investigators and clinical trial institutions, to clarify the responsibilities of each party
• The contract signed by the sponsor and the relevant parties must indicate that the sponsor and the NMPA can access the clinical trial site to consult the source data, source documents, and reports

To standardize the submission of drug clinical trial data, meet the drug registration application data requirements, and improve the efficiency of drug review, the NMPA-No16-2020 provides guidance on the content and format of clinical trial data. The guidance is based on the data submission requirements of international regulatory agencies, including the Clinical Data Interchange Standards Consortium (CDISC). In addition, the NMPA-No74-2020 has details on the management of records and data that must be provided to the NMPA during clinical trials in China. It indicates that data refers to the information generated during drug development, production, operation, and use, including text, values, symbols, images, audio, pictures, maps, barcodes, etc.

Per the NMPA-No2-2015, for international multicenter clinical trials when the main efficacy and important safety evaluation indicators are laboratory evaluation indicators, it is recommended to establish a central laboratory for unified testing. The laboratory should have the corresponding clinical laboratory qualifications. Where a regional central laboratory is established, the quality control consistency verification between laboratories must be carried out regularly to ensure the consistency and reliability of experimental results.

The NMPA-No48-2018 presents quality management guidelines for Phase III clinical trials using innovative drugs. The guide addresses information the sponsor should provide to the NMPA related to the active pharmaceutical ingredient and its production, considering participants’ safety, drug characteristics, dosage form and route of administration, development stage, target population, and severity of the disease.

Finally, the NMPA has issued the following quality management and technical guidelines for conduct during clinical trials. See each of these documents, for additional details:

• NMPA-No29-2024 – guidelines for pharmaceutical research and changes to biological products during clinical trials
• Risk-Prcdr – procedures for safety information assessment and risk management during clinical trials
• DctrlzCTs-Rare – technical guidelines for decentralized clinical trials using rare disease drugs
• GeneCTs-Rare – technical guidelines for clinical trials of gene therapy products for rare diseases
• PatientCtr-Risk, PatientCtr-Imp, and PatientCtr-Design – technical guidelines for patient-centered drug clinical trials, including design and risk assessment
• NMPA-No15-2023 – technical guidelines for clinical trials of chemical compound drugs
• NMPA-No34-2022 – guidelines for protocol changes during drug clinical trials
• NMPA-No32-2022 – guidelines for clinical trials of topically administered local effective drugs
• NMPA-No31-2022 – guidelines for conduct of research with in vivo gene therapy products
• NMPA-No30-2022 – guidelines for conduct of research involving immune cell therapy products
• NMPA-No29-2022 – guidelines for conduct of research with in vitro gene modification
• NMPA-No27-2022 – guidelines for conduct of research involving specific human immunoglobulins
• NMPA-No22-2021 – a research and development model to guide researchers in managing pharmaceutical changes of innovative drugs
• NMPA-No17-2022 – guidelines for clinical pharmacological research of biosimiliars
• NMPA-No4-2022 – guidelines for research of human bioavailability of bioequivalence of innovative drugs
• NMPA-No71-2021 – guidelines for research of drugs for rare diseases
• NMPA-No68-2021 – guiding principles for writing the clinical risk management plan
• NMPA-No66-2021 – guiding principles for multiplicity issues during drug clinical trials, which refers to multiple testing problems that can lead to errors and inappropriate interpretation of trial results
• NMPA-No63-2021 – guidelines for drug clinical trial data management and statistical analysis plan
• NMPA-No62-2021 – guidelines for the application of patient-reported outcomes in drug clinical development
• NMPA-No59-2021 – guidelines for analyzing the effectiveness of clinical studies of drugs
• NMPA-No50-2021 – guidelines for long-term follow-up for clinical research of gene therapy products
• NMPA-No6-2021 – guidelines for sponsors in adopting and implementing an adaptive design to improve the success and quality of the research results
• Chngs-MktChem – technical guidelines for pharmaceutical change research of listed chemicals
• Chngs-MktChemBio – technical guidelines for clinical changes in marketed chemicals and biological products
• NMPA-No21-2021 – technical requirements of pharmaceutical research and evaluation of overseas listed and domestic unlisted chemicals
• NMPA-No54-2020 – technical guidelines for clinical trials of improved chemical drugs
• Chngs-MktBio – technical guidelines for pharmaceutical change research of marketed biological products

Per the VaccineLaw, during the research and development phase for vaccines, the sponsor must establish a biosafety management system that strictly controls biosafety risks, strengthens biosafety management of pathogenic microorganisms (e.g., bacterial strains), protects the health of operators and the public, and safeguards against bacterial toxicity. The use of pathogenic microorganisms, such as strains, is legal and legitimate. The strains and cell strains used during research and development must have clear histories, biological characteristics, and generations. Detailed documentation and archives must be established to ensure that the source is legal, clear, and traceable; if the source is unknown, then it cannot be used.

As delineated in MgmtHumanGen, for international cooperative projects using human genetic resources (HGR), the sponsor must ensure the participation of the Chinese partner. During the study period, the Chinese partner and its researchers must fully participate in the research. All records and data information in the research process, and all backup documentation, must be accessible to the Chinese partner. Both the foreign and Chinese parties have the right to use the information developed with the HGR.

Monitoring Requirements

As per the NMPA-GCP-No57-2020, the purpose of monitoring is to ensure the rights and interests of participants in clinical trials, to ensure that the data in trial records and reports are accurate and complete, and to ensure that trials comply with the agreed protocol and relevant regulations. The NMPA-GCP-No57-2020 and CHN-37 require the sponsor to establish a systematic, prioritized, risk-based method to monitor clinical trials. NMPA-GCP-No57-2020 directs the sponsor to formulate audit procedures and an inspection plan with a special emphasis on protecting the rights and interests of participants, ensuring the authenticity of data, and managing risks in clinical trials. On-site supervision and centralized supervision should be conducted based on the combination of risks of clinical trials. The audit procedures must establish objectives, methods, frequency, and format content of audit reports. All problems observed and discovered by the auditors during the inspection process must be recorded in writing. The sponsor may conduct special inspections in addition to routine inspections. The sponsor selects a person independent of the clinical trial to serve as an inspector. Inspectors must have received corresponding training and inspection experience and be able to effectively perform inspection duties.

As indicated in NMPA-No2-2015, for international multicenter clinical trials, the sponsor or the contract research organization (CRO) entrusted by the sponsor must conduct supervision of each clinical trial center, the monitoring report must be archived, and the sponsor must periodically review the monitoring work. The sponsor or the CRO must formulate an audit plan and have a unified audit report template and audit result reporting system.

Further, NMPA-GCP-No57-2020 states that researchers and clinical trial institutions must agree to supervision and inspection organized by the sponsor and the NMPA. The sponsor must provide an inspection report or certificate when requested by the NMPA. In accordance with the DRR and CHN-8, NMPA’s Center for Drug Evaluation (CDE) will make a risk-based decision on whether to conduct an inspection of a clinical trial, based on the level of drug innovation and the past verification history of the clinical trial site. See NMPA-No56-2023 for NMPA’s management measures that standardize the supervision and inspection of institutions conducting drug clinical trials. In addition, NMPA-No22-2022 indicates that sponsors have the main responsibility for pharmacovigilance inspections during the conduct of a clinical trial. See NMPA-No22-2022 for key considerations during routine and causal inspections, evaluation criteria, risk factors, inspection methods, and other inspection implementation guidance.

The NMPA-No28-2020 further clarifies the link between on-site inspection of drug registration and the pre-market good manufacturing practice (GMP) compliance inspection. Based on the innovation and risk characteristics of an IP, the pre-market GMP compliance inspection will be conducted by the appropriate level regulatory authority (i.e., the CDE, province, autonomous region, or municipality). See the NMPA-No28-2020 for detailed inspection requirements.

Also, see the NMPA-GCP-No57-2020 and CHN-37 for additional guidance on audits and inspections. See NMPA-No11-2022 for guiding principles on use of risk-based statistical evaluation methods for centralized monitoring of drug clinical trials.

Premature Study Termination/Suspension

The NMPA-GCP-No57-2020 mandates that researchers, clinical trial institutions, and sponsors abide by the trial protocol, SOPs, and relevant laws and regulations. If non-compliance is found, the sponsor must take immediate measures to correct them and ensure the clinical trials are in compliance. The NMPA-GCP-No57-2020 and CHN-37 state that when an important compliance problem is discovered that may have a significant impact on the safety and rights of participants or the reliability of clinical trial data, the sponsor must conduct a root cause analysis in a timely manner and take appropriate corrective and preventive measures.

The NMPA-GCP-No57-2020 specifies that if the trial protocol is violated or there is a serious quality problem, the sponsor must hold the relevant personnel accountable and send a written report to the NMPA at CHN-58. When it is found that the investigator or clinical trial institution has serious non-compliance problems, the sponsor must terminate the investigator or clinical trial institution from continuing to participate in the clinical trial. The sponsor should also send a written report to the NMPA. At the same time, sponsors and researchers should take corresponding emergency safety measures to protect the safety and rights of participants. A sponsor who terminates or suspends clinical trials early must immediately notify the investigator, clinical trial institutions, and the NMPA, and explain the reasons.

Further, the NMPA-GCP-No57-2020 states that when a clinical trial is completed or terminated early, the sponsor must submit a clinical trial report to the NMPA. The clinical trial summary report must comprehensively, completely, and accurately reflect the clinical trial results. The safety and effectiveness data of the clinical trial summary report must be consistent with the clinical trial source data. The Measures-Ethics indicates that for research that has been approved for implementation, researchers must promptly submit reports on suspension and termination to the EC.

Quality Assurance/Quality Control

As stated in the CTRules and the G-KenyaCT, the sponsor is responsible for maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, recorded, and reported in compliance with the protocol, the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14), the STI-Regs, and other applicable regulatory requirements. QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed. In addition, per the STI-Regs, all persons and research institutions (i.e., sponsors) undertaking research in Kenya must ensure the highest standards and quality of research for the realization of institutional mandates and national priorities.

In addition to complying with KEN-14, the G-KenyaCT indicates QA processes should be developed to ensure:

• Regular and continuous monitoring of the study and the implementation of monitoring reports’ recommendations
• Submission of the study monitoring plan to the Pharmacy and Poisons Board (PPB) during the initial submission of the application
• The clinical trials research site must have valid registrations and approvals
• Patient safety and confidentiality are not compromised
• Analysis or evaluation of samples is performed in accordance with the protocol and good clinical practice (GCP) principles and, where applicable, the contract/agreement, the work instruction, and associated methods
• Adherence to the laboratories’ policies and SOPs
• Trial data is recorded and reported accurately, legibly, completely, and in a timely manner
• Trial data is archived
• Preparation of a work instruction detailing the procedures that will be used to conduct the analysis or evaluation prior to the initiation of sample analysis or evaluation, as necessary
• Be built or adapted for the purpose
• Have automated equipment for routine hematology, biochemistry, and serology tests
• Have procedures for analyzer calibration and quality control
• Regular maintenance of all the equipment, including point-of-care equipment
• Have a procedure for transporting samples safely and quickly from clinical areas to the laboratory
• Have written procedures for all assays, and to validate the assays
• Reagents and consumables are used within their expiry dates based on a stock control procedure
• Records are kept, including source documents and final reports
• Have a procedure for authorizing and releasing results
• Have a procedure for ‘flagging’ and notifying medical staff of abnormal results
• Have a laboratory information management system, and validate and back up the system
• Protective clothing and safety equipment are provided for staff
• Have a central alarm system for all fridges and freezers
• Have an internal audit program

Per KEN-14, the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should use a risk-based approach that includes:

• During protocol development, identify processes and data that are critical to ensure participant protection and the reliability of trial results
• Identify risks to critical trial processes and data
• Evaluate the identified risks against existing risk controls
• Decide which risks to reduce and/or which risks to accept
• Document quality management activities and communicate to those involved in or affected by these activities
• Periodically review risk control measures to ascertain whether the implemented quality management activities are effective and relevant
• In the clinical study report, describe the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken

Per the G-KenyaCT protocol violations and protocol deviations must be reported to the PPB within seven (7) days of the principal investigator (PI) becoming aware of them. The details to be reported must include:

• Date of the deviation/violation
• Study participant(s) affected
• Name of the treating physician
• Detailed description of the deviation/violation
• Indication whether the study participants were adversely affected by the deviation/violation
• Explanation of why the deviation/violation occurred
• Measures taken to address the deviation/violation
• Measures taken to preclude future recurrence of the deviation/violation

In addition, see G-KenyaCT for information about medical care of trial participants during and following the clinical trial. Also see the Bft-Risk for a standardized approach for evaluating and reporting the balance between the benefits and risks of health products, which includes investigational products (IPs) undergoing clinical trial application.

The CT-Emrgcy provides guidance to sponsors, PIs, and institutions on the conduct of clinical trials during public health emergencies to maximize the safety of research participants, minimize risks to participants and the community, and ensure the integrity of the clinical trials. See CT-Emrgcy for details on a range of issues, including contingency planning, communications with participants, changes to studies, protocol deviations, reporting, and supply of IPs during a public health emergency.

Controlled Human Infection Studies

The G-KenyaCT also provides detailed information on controlled human infection studies (CHIS) requirements to ensure investigator/study personnel compliance with GCP and other QA/QC requirements, including the following:

• The well characterized strain of an infectious agent should be administered at a controlled dose and by a specific route to carefully selected adult volunteers
• The studies require safe and accurate microbiology, good clinical facilities, careful recruitment, and monitoring
• Participants must be monitored for evidence of carriage or infection under medical supervision to anticipate or manage symptoms of disease and adverse events
• The value of the information to be gained should clearly justify the risks and the study must have a risk mitigation plan
• The investigators should be adequately qualified, trained, and experienced in the conduct of CHIS as well as treating patients with the infectious disease being investigated

For the complete list of requirements, see the G-KenyaCT.

The G-ECBiomedRes provides additional considerations when investigational vaccines contain active or live-attenuated micro-organisms:

• The participant to be vaccinated should be given adequate information about the adverse effects.
• Should participants in the control group contract the disease for which a vaccine is being tested, free treatment must be provided.
• Because the risks associated with vaccines produced by recombinant DNA techniques are not completely known, PPB guidelines must be strictly followed.
• Post-trial access to the vaccine should be available to the control group

Monitoring Requirements

As part of its QA system, the G-KenyaCT requires the sponsor to develop an internal audit program. The G-KenyaCT defines an audit as a systematic examination, carried out independently of those directly involved in the trial, to determine whether the conduct of a trial complies with the agreed study protocol and whether data reported are consistent with those on record at the site. Further, the sponsor is required to obtain agreement from all involved parties to ensure direct access to all trial related sites, source data/documents, reports for monitoring and auditing purposes, and inspection by domestic and foreign regulatory authorities An investigator must, upon request from any properly authorized officer or employee of PPB, at reasonable times, permit such officer or employee to have access to, and copy and verify any records or reports made by the investigator.

Per KEN-14, the sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The extent and nature of monitoring is flexible and permits varied approaches that improve effectiveness and efficiency. The sponsor may choose onsite monitoring, a combination of onsite and centralized monitoring, or, where justified, centralized monitoring. The sponsor should document the rationale for the chosen monitoring strategy (e.g., in the monitoring plan).

KEN-31 indicate that the National Commission for Science, Technology and Innovation (NACOSTI) may conduct an evaluation, or cause an evaluation to be conducted, of a research study to assess and evaluate compliance with the conditions of the applicable research license.

Premature Study Termination/Suspension

The G-KenyaCT states that if a trial is terminated by the PI or the sponsor, the PI or the sponsor must inform the PPB not later than 15 days following the termination date. The co-investigators must also be informed as soon as possible and should be advised in writing of potential risks to the research participants, and they must ensure that patients continue to receive medical care. The PPB must be provided with reason(s) for the termination and its impact on the proposed or ongoing trials with respect to the IP, including issues relating to IP accountability and disposal as well as record(s) maintenance. In addition, the PPB may withdraw the authorization to conduct a clinical trial if it finds that the safety of the participants is compromised or that the scientific reasons for conducting the trial have changed.

According to KEN-14, if it is discovered that noncompliance significantly affects or has the potential to significantly affect participant protection or reliability of trial results, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions. Further, the EC should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor.

Electronic Data Processing System

Per the NMPA-GCP-No57-2020, the sponsor must meet the following requirements in electronic data processing during clinical trials:

• Select qualified personnel to supervise data processing, data verification, statistical analysis, and the writing of trial summary reports
• Use an electronic data management system that passes reliable system verification and meets the pre-set technical performance to ensure the integrity, accuracy, and reliability of the test data, and to ensure that the system is always valid for verification during the entire test process
• Have complete standard operating procedures (SOPs) that cover the setup, installation, and use of electronic data management; the SOPs must describe the verification, functional testing, data collection and processing, system maintenance, system safety, testing, change control, data backup, recovery, and system emergency plans
• Ensure the SOPs cover the responsibilities and training of sponsors, researchers, and clinical trial institutions when using computerized systems
• Prescribe in advance the method of data modification
• Ensure that the data conversion process is consistent with the original data and visibility is maintained during the process
• Ensure the security of the electronic data management system, and that unauthorized personnel cannot access it; keep a list of persons authorized to modify data; electronic data is backed up in time; clinical trials designed by blind methods are always blinded, including data entry and processing

In accordance with NMPA-GCP-No57-2020, when the information system of a clinical trial institution has the conditions for establishing a clinical trial electronic medical record, the researcher should use it first, and the corresponding computerized system should have complete authority management and audit trails, which can be traced to the creator or modifier of the record. Researchers must supervise the data collection. They must ensure that all clinical trial data are obtained from clinical trial source documents and trial records, and are accurate, complete, readable, and timely. The source data should be attributable, legible, original, accurate, complete, consistent, and durable. The modification of the source data must be explained and transparent. Relevant medical records should be included in the outpatient or inpatient medical record system. During the processing of clinical trial information, care must be taken to avoid illegal or unauthorized access, disclosure, dissemination, modification, damage, or loss of information. The record, processing, and preservation of clinical trial data must ensure the confidentiality of records and participant information. In the contract with the investigator and the clinical trial institution, the sponsor should clarify the retention time, cost, and handling of the documents.

Per the NMPA-No2-2015, international multicenter clinical trials must adopt a unified data processing center for data query, verification, storage, and analysis.

The NMPA-No74-2020 has additional guidance and requirements for the sponsor’s electronic system.

In addition, as per the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (CHN-37), when using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. Per CHN-37, the sponsor should base their approach to validate such systems on a risk assessment that takes into consideration the intended use and the potential of the system to affect participant protection and reliability of trial results. In addition, the sponsor should maintain SOPs for the systems that cover system setup, installation, and use. The responsibilities of the sponsor, investigator, and other parties should be clear, and the system users should be provided with training. Refer to CHN-37 for additional information.

Records Management

Per the NMPA-GCP-No57-2020 and CHN-37, the sponsor must retain the clinical trial data related to the sponsor and participating parties in the clinical trial. The transfer of data ownership must comply with the requirements of relevant laws and regulations. The sponsor must send written notification to the investigator and clinical trial institution about the requirements for preserving clinical trial records and when the trial-related records are no longer needed. At the beginning of a clinical trial, the investigator, clinical trial institution, and sponsor must establish archive management of the necessary documents. At the end of the clinical trial, an inspector must review and confirm the necessary documents of the investigator, clinical trial institution, and sponsor, and these documents must be properly kept in their respective clinical trial archives. Clinical trial documents must be retained for at least five (5) years after the trial drug is approved for marketing or after the termination of the clinical trial.

In addition, the NMPA-GCP-No57-2020 emphasizes that clinical trial essential documents are important to the National Medical Products Administration (NMPA)'s inspection of the clinical trial. Sponsors, investigators, and clinical trial institutions must confirm that they have appropriate storage conditions for preserving the essential documents. SOPs for document management should be formulated. The source data or its certified copy must be kept complete and readable during the retention period. In addition, the sponsor must ensure that the investigator can always consult and enter data in the case report form (CRF) reported to the sponsor during the trial. The data should not be controlled by the sponsor alone. The photocopies used as source documents should meet the requirements for certified copies. The NMPA-No37-2020 details the essential documents required for clinical trials to prove compliance with the NMPA-GCP-No57-2020. The NMPA-No74-2020 contains additional requirements on record management during a clinical trial.

Electronic Data Processing System

Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14). As per KEN-14, when using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. Per KEN-14, the sponsor should base their approach to validate such systems on a risk assessment that takes into consideration the intended use and the potential of the system to affect participant protection and reliability of trial results. In addition, the sponsor should maintain standard operating procedures (SOPs) for the systems that cover setup, installation, and use. The responsibilities of the sponsor, investigator, and other parties should be clear, and the system users should be provided with training. Refer to KEN-14 for additional information.

Records Management

According to the G-KenyaCT, it is the responsibility of the investigator and the sponsor to archive safely all trial-related documentation. All Kenyan trial site-related documentation must be archived within the country and not exported. Additionally, the sponsor/applicant must inform the Pharmacy and Poisons Board (PPB)’s Expert Committee on Clinical Trials (ECCT) in writing prior to destroying any trial documents. The notification must include the protocol number, start and end date, and the license number.

The G-KenyaCT states that study documents must be archived for a minimum of 10 years from the end of the study. Also, records must be made available to the PPB within three (3) days if there is a concern regarding the use of a clinical trial drug and/or a risk to the health of the clinical trial participant. In any other case, records must be provided within seven (7) days of request.

Per the STI-Regs, sponsors should store research findings and information regarding research systems in a designated location with clear labels of the subject area. Research findings must be documented in bound books or documents with the research title, author, year, and other relevant information clearly printed on the cover page. A report of research work by staff and the research institution must be submitted to the National Commission for Science, Technology and Innovation (NACOSTI) within two (2) months after publication or compilation of the research report.

In addition, KEN-14 states that the sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should allow for document identification, version history, search, and retrieval. The sponsor should ensure that the investigator has control of and continuous access to the data reported to the sponsor. The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.

Responsible Parties

For requirements on personal data protection, the PIPL delineates that personal information processors are organizations or individuals who independently determine the purpose and method of processing personal information during personal information processing activities.

Data Protection

Per the PIPL, the personal information processor must ensure the safety of the personal information processed, including following principles of openness and transparency, disclosing personal information processing rules, and clearly indicating the purpose, method, and scope of processing. The PIPL applies to the processing of personal information in China for people located within the country. In addition, the PIPL and the DataSec-Regs apply to data processing activities conducted outside of China involving personal information of people located in China under the following circumstances: (1) where the processing is for the purposes of providing products or services to individuals located in China, (2) where the processing is for analyzing and evaluating the behavior of individuals located in China, or (3) other circumstances stipulated by laws and regulations.

Per the PIPL, the processing of personal information should have a clear and reasonable purpose and should be directly related to the purpose of processing with the least impact on personal rights and interests. The personal information processor must follow the principles of lawfulness, fairness, necessity, and good faith when processing personal information, and must not process personal information through misleading, fraudulent, coercive, and other methods. The collection of personal information must be limited to the minimum scope for the purpose of processing, and personal information must not be collected excessively, while following the principles of openness and transparency. The personal information processor must disclose processing rules and clearly indicate the purpose, method, and scope of processing. When handling personal information, the data quality must be guaranteed, and any inaccuracy and incompleteness of personal information must not adversely affect personal rights and interests. For additional data protection details see the DataSec-Regs, which supplements the PIPL.

The PIPL states that for sensitive personal information, which includes medical health information, the personal information processor must adopt additional protective measures, including informing participants of the necessity of processing sensitive personal information and the impact on personal rights and interests. Unless otherwise provided by laws and administrative regulations, the retention period of personal information must be the shortest time necessary to achieve the processing purpose. Also see the Id-SPI for guidance on identifying sensitive personal information.

Further, the DataSec-Regs states that where a network data processor provides or entrusts other network data processors to process personal information and important data, they must agree to the following:

• The recipient of network data must fulfill its obligation to protect network data security and process personal information and important data in accordance with the agreed purpose, method, scope, etc.
• If two (2) or more network data processors jointly decide on the purpose and method of processing personal information and important data, they must agree upon their respective rights and obligations.

Per the PIPL and the DataSec-Regs, to send personal information outside of China, the personal information processor must meet one (1) of the following conditions (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

• Pass the security assessment organized by the national cybersecurity and information department (See below in Data Security)
• Conduct personal information protection certification by professional institutions in accordance with the requirements of the Cyberspace Administration of China (CAC)
• Enter into a contract with the overseas recipient in accordance with the standard contract formulated by the CAC stipulating the rights and obligations of both parties
• Other conditions stipulated by laws, administrative regulations, or national cyberspace administration departments
• Where China’s international treaties and agreements permit providing personal information to foreign recipients
• It is necessary to provide personal information overseas to conclude or perform a contract to which the individual is a part
• To implement cross-border human resources management in accordance with labor rules and regulations formulated in accordance with the law and collective contracts signed in accordance with the law, and providing employees' personal information overseas is necessary
• It is necessary to provide personal information overseas to perform legal duties or obligations
• In an emergency, it is necessary to provide personal information overseas in order to protect the life, health, or property safety of a natural person

The PIPL states that the personal information processor must inform the participant of the name of the foreign recipient, contact information, processing purpose, processing method, and types of personal information. In addition, per the PIPL and the DataSec-Regs, the foreign personal information processor must appoint a representative located in China to be responsible for matters related to personal information protection and report the representative’s contact information to the data protection regulators—the CAC.

The DataScrty requires the personal information processor to manage its data processing activities to ensure data security, promote data development and utilization, protect the legitimate rights and interests of individuals and organizations, and safeguard national sovereignty, security, and development interests. CAC-No11-2022 standardizes requirements for exporting “important data” and personal information to protect the rights and interests of personal information, preserve national security and the societal public interest, and promote the cross-border security and free flow of data. Important data is defined as data that, once tampered with, destroyed, leaked, or illegally obtained or used, might endanger national security, economic operations, social stability, public health, or safety in China. Also see the DataSec-Regs for additional requirements on doing risk assessments and handling and reporting on important data. Personal information processors must conduct security assessments of personal data collected and generated in China before exporting it to overseas data processors. Data export security assessments focus on assessing risks that data export activities may bring to national security, the public interest, or the lawful rights and interests of individuals or organizations. The DataTrsfr-Regs delineates exemptions from the requirements to conduct security assessments, for example in an emergency where it is necessary to provide personal information overseas in order to protect the life, health, or property safety of a natural person. If DataTrsfr-Regs conflicts with CAC-No11-2022, the DataTrsfr-Regs supersede.

When applicable, the DataScrty states that the assessment report must be submitted to CAC through the provincial-level department where the personal information processor is located, and include the following materials:

• Declaration form
• Self-assessment report on data export risks
• Data agreements between the data processor and the overseas recipient

The CAC-No11-2022 states that data export activities that have already been conducted before the implementation of CAC-No11-2022 are noncompliant and must be rectified within six (6) months of the effective date of CAC-No11-2022 (i.e., by March 1, 2023). See the CAC-No11-2022 for additional details on conducting the data export security assessment, the provincial inspections, appeal procedures, and CAC’s review actions and timeline.

Consent for Processing Personal Data

Per the PIPL, personal consent must be made voluntarily and with the participants’ full knowledge of the processing purpose, processing methods, and types of personal information processed. In an emergency, if it is not possible to obtain consent in a timely manner to protect the life, health, property, and safety of participants, the personal information processor must promptly notify the individual after the emergency is eliminated. (Note: consent to data processing is not the same as informed consent to the research described in the Informed Consent topic.) As indicated in the DataSec-Regs, individual consent is defined as specific and unambiguous consent given by an individual for specific processing of their personal information.

The DataSec-Regs supplements the PIPL, adding detailed protection requirements when personal information processing is based on individual consent:

• The collection of personal information must not be collected beyond the scope, and personal consent must not be obtained through misleading information, fraud, coercion, etc.
• When processing sensitive personal information such as biometrics, religious beliefs, specific identities, and medical health the individual's separate consent must be obtained
• When processing the personal information of a minor under the age of 14, the consent of the minor’s parent/legal guardian must be obtained
• Personal information must not be processed beyond the purpose, method, type, or retention period of the personal information that the individual has consented to
• Processors must not frequently seek consent after an individual has clearly expressed their disagreement with the processing of their personal information
• If the purpose, method, or type of personal information processing changes, the individual’s consent must be obtained again
• If laws and administrative regulations provide that written consent must be obtained for the processing of sensitive personal information, such provisions must apply

Responsible Parties

For the purposes of data protection requirements, DPA delineates that the sponsor acts as the “data controller” in relation to research data. This is because the sponsor determines the purpose and means of processing personal data. The "data processor" processes personal data on behalf of the data controller. Data controllers and processors must be registered with the Kenya Data Commissioner. Per the DataProtect, an application for registration of a data controller or data processor must be on Form DPR1 (found in the First Schedule of DataProtect) with supporting materials and the required registration fees as specified in the Second Schedule. See the DataProtect for additional details on registration requirements.

Data Protection

Per the DPA, the data controller (sponsor) must ensure that personal data is:

• Processed in accordance with the right to privacy of the data subject
• Processed lawfully, fairly, and in a transparent manner in relation to any data subject
• Collected for explicit, specified, and legitimate purposes and not further processed in a manner incompatible with those purposes
• Adequate, relevant, and limited to what is necessary in relation to the purposes for which it is processed
• Collected only where a valid explanation is provided whenever information relating to family or private affairs is required
• Accurate and, where necessary, kept up to date, with every reasonable step being taken to ensure that any inaccurate personal data is erased or rectified without delay
• Kept in a form that identifies the data subjects for no longer than is necessary for the purposes for which it was collected
• Not transferred outside Kenya, unless there is proof of adequate data protection safeguards or consent from the data subject

The DataProtect, which implements the DPA, requires data controllers and data processors to develop, publish, and regularly update a policy on their personal data handling practices. The policy should include the nature of personal data collected and held, how a data subject may access their personal data, complaints handling mechanisms, the lawful purpose for processing personal data, and requirements for when personal data is to be transferred outside Kenya. Regarding cross-border transfers of data, a data controller or data processor who is a transferring entity must (before transferring personal data out of Kenya) ascertain that the transfer is necessary. This necessity decision should be based on considerations such as data protection safeguards, an adequacy decision made by the Data Commissioner, and if there is consent of the data subject.

Per the DataProtect, data controllers and/or data processors must retain personal data processed for a lawful purpose and only as long as may be reasonably necessary for the purpose for which the personal data is processed. A data controller or data processor must establish a personal data retention schedule with appropriate time limits and periodic reviews. When the retention period has ended, the personal data must be erased, anonymized, or pseudonymized.

See DataProtect for additional details on data protection, including data subject rights, data protection design and principles, notification of breaches, impact assessments, and exemptions.

See Parts IV-VII of the DPA for detailed requirements on data processing, sensitive personal data, exemptions, and transfer of personal data outside of Kenya. The G-ECBiomedRes requires compliance with the DPA.

Consent for Processing Personal Data

Per the DPA, the data controller (sponsor) or data processor must bear the burden of proof for establishing a data subject’s consent to the processing of their personal data for a specified purpose. For the purposes of processing personal data, consent means any manifestation of express, unequivocal, free, specific, and informed indication of the data subject’s wishes by a statement or by a clear affirmative action, signifying agreement to the processing of personal data relating to the data subject. Unless otherwise provided under the DPA, a data subject has the right to withdraw consent at any time. The withdrawal of consent must not affect the lawfulness of processing based on prior consent before its withdrawal.

The DataProtect requires data controllers and data processors to ensure that a data subject has the capacity to consent and voluntarily gives consent. In seeking consent (prior to the processing), the data subject should be informed of:

• The identity of the data controller or data processor
• The purpose of each of the processing operations for which consent is sought
• The type of personal data that is collected and used
• Information about the use of the personal data for automated decision-making, where relevant
• The possible risks of data transfers due to absence of an adequacy decision or appropriate safeguards
• Whether the personal data processed will be shared with third parties
• The right to withdraw consent
• The implications of providing, withholding, or withdrawing consent

Per the DataProtect, this information may be presented to the data subject through a written notice, oral statement, audio or video message. The data controller or a data processor must ensure that the data subject has the capacity to voluntarily give consent that is specific to the purpose of processing.

Children

The DPA indicates that in cases where the data subject is a minor, a person who has parental authority or a guardian may exercise personal data protection rights conferred on the subject. With regard to data processing, the DPA requires that every data controller (sponsor) or data processor must not process personal data relating to a child unless consent is given by the child's parent or guardian and the processing is in a manner that protects and advances the rights and best interests of the child. A data controller or data processor must incorporate appropriate mechanisms for age verification and consent to process personal data of a child, including available technology, volume of personal data processed, proportion of such personal data likely to be that of a child, possibility of harm to a child arising out of processing of personal data, and other factors as may be specified by the Kenya Data Commissioner.

Mentally Impaired

The DPA indicates that in cases where the data subject has a mental or other disability, a person duly authorized to act as the participant’s guardian or administrator may exercise personal data protection rights conferred on the subject.

Obtaining Consent

In all Chinese clinical trials, a freely given informed consent is required to be obtained from each participant in accordance with the requirements set forth in the NMPA-GCP-No57-2020, the Measures-Ethics, the RegEthics, and the EC-Guide. In addition, China is implementing the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (CHN-37) as a guidance document. As per the NMPA-GCP-No57-2020, the DAL, the EC-Guide, and CHN-37, the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by an ethics committee (EC) and provided to the National Medical Products Administration (NMPA) with the clinical trial application. Per the MgmtHumanGen, the ICF must also be provided to the Ministry of Science and Technology (MOST) (now National Health Commission (NHC)) as part of its application procedures for human genetic resource (HGR) licenses. In addition, per the VaccineLaw, in carrying out a vaccine clinical trial, the investigator is required to obtain a signed ICF from the participant or legal representative/guardian. (Note that per SC-Order777 and NHC-HGRmgt, management of HGR was transferred from MOST to NHC, effective May 1, 2024).

The NMPA-GCP-No57-2020, the Measures-Ethics, and CHN-37 state that the investigator, or a person designated by the investigator, must provide detailed research study information to the participant or the legal representative/guardian. As delineated in the NMPA-GCP-No57-2020, the Measures-Ethics, and the EC-Guide, the ICF content should be briefly and clearly presented orally or, in a written language, that is easy to understand, and commensurate with the comprehension level of the research participants. The participant and the legal representative/guardian should also be given adequate time to consider whether to participate. The Measures-Ethics indicates that ICFs must contain sufficient, complete, and accurate information, and be expressed in language, text, video images, and so forth that research participants can understand. Researchers must explain each item to the research participants in accordance with the content of the ICF.

As per the NMPA-GCP-No57-2020, CHN-37, and the EC-Guide, none of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant or the legal representative/guardian to waive or appear to waive their legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representatives from their liabilities for any negligence. The investigator should give the participant sufficient time to understand the ICF content, and the participant should make a decision whether or not to agree to participate in the study and sign the form. In psychological research, because informed consent may affect the participant’s response to the question, thereby affecting the accuracy of the research results, the investigator can fully inform the participant and obtain informed consent following the project study’s completion.

Per DctrlzCTs-Rare, for decentralized clinical trials of rare diseases, electronic informed consent may be used. When electronic informed consent is used, the informed consent process needs to be recorded, archived, and traceable. For rare disease participants with limited mobility, researchers can use remote informed consent to more quickly and easily obtain consent and ensure that all participants have the latest version in a timely manner. To use electronic informed consent in these scenarios, researchers must conduct evaluation and verification in advance and provide the participants with instructions and training. Before adopting electronic informed consent, the participants should be fully informed of the scope of data collection, access rights, etc. generated during the electronic informed consent process. During the informed consent process, researchers should ensure data security and the privacy of the participants (including their legal representative/guardian) are protected.

Per the MgmtHumanGen, to collect Chinese HGR for a clinical trial, the participant must agree to participate in the clinical trial in writing. Information provided to the participant must be comprehensive, complete, true, accurate, and must not conceal information nor be misleading or deceiving.

For specific consent requirements for human genome editing research, see the Consent for Specimen section.

Re-Consent

The NMPA-GCP-No57-2020 and CHN-37 require investigators to use the latest version of the ICF approved by the EC and, if necessary, participants in the clinical trial process should sign an updated ICF again. If new information may affect the participant’s continued participation in the trial, the investigator must promptly notify the participant and the legal representative/guardian and make corresponding records. Per the RegEthics and the Measures-Ethics, the investigator should obtain re-consent under the following circumstances (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

• The research plan, scope, and content have changed
• Research using previously collected samples that were used for diagnosis and treatment and were labeled with personal identifiable labels
• Research using human biological samples or related clinical disease history data with subject-identifiable labels from existing biological sample repositories/databases
• The risks related to the research are increased or substantially increased
• The level of civil capacity of research participants has been raised
• Other changes occur during the research

Language Requirements

The NMPA-GCP-No57-2020, the Measures-Ethics, the RegEthics, and the EC-Guide require the ICF to be presented in oral or written form in a language that the participant is able to understand.

Documenting Consent

Per the NMPA-GCP-No57-2020, the Measures-Ethics, CHN-37, and the EC-Guide, the participant and the legal representative/guardian, and researchers who perform informed consent, should sign and date the ICF. Per the Measures-Ethics, when the research participants do not have the ability to express their consent in writing, the researcher must obtain their oral informed consent and have audio and video recordings and other process records and supporting materials.

Per the NMPA-GCP-No57-2020, CHN-37, and the EC-Guide, if the ICF is not signed by the participant, the relationship should be marked on the form. If the participant and the legal representative/guardian lack the ability to read, an impartial witness must witness the entire informed consent process. The witness should sign and date the ICF after the following steps have occurred:

• The written ICF and any other written information to be provided to the participant is read and explained to the participant and the legal representative/guardian
• The participant and the legal representative/guardian, have orally consented to the participant’s involvement in the trial, and has signed and dated the ICF, if capable of doing so

Before participating in the study, the participant or the legal representative/guardian should receive a copy of the signed and dated ICF.

Waiver of Consent

The EC-Guide and the RegEthics state that the EC may grant a waiver of informed consent when the following conditions are met (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

• The risk that the subject may suffer does not exceed the minimum.
• The exemption from obtaining the informed consent of the subject does not have a negative impact on the participant’s rights and interests.
• The use of human bodily materials or data that can identify the information for research has made it impossible to find the participant, and the research project does not involve personal privacy and commercial interests.
• The biological sample donor has signed an ICF agreeing that the donated sample and related information can be used for all medical research.
• The exemption requires informed consent and does not mean that it is exempt from the review of the EC.

Obtaining Consent

In all Kenyan clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in the CTRules, the G-KenyaCT, the G-ECBiomedRes, and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (KEN-14). (Per the G-KenyaCT, research must be conducted in accordance with the requirements set forth in KEN-14.) The informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by a National Commission for Science, Technology and Innovation (NACOSTI)-accredited institutional ethics committee (EC). The ICF must be provided to the Pharmacy and Poisons Board (PPB) with the clinical trial application. (See the Required Elements section for details on what should be included in the form.)

The CTRules, the G-KenyaCT, and the G-ECBiomedRes state that the investigator, or the designated representative, must provide detailed research study information to the participant or legal representative/guardian. Per G-ECBiomedRes, all individual consent must be written and, in no case, should collective community agreement or the consent of a community leader or other authority substitute for an individual informed consent. The G-KenyaCT and the G-ECBiomedRes also specify that the oral and written information concerning the trial, including the ICF, should be easy to understand and presented without coercion or unduly influencing a potential participant to enroll in the clinical trial. None of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant or legal representative/guardian to waive or to appear to waive the legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or the representatives from their liabilities for any negligence. The participant or legal representative/guardian should also be given adequate time to consider whether to participate.

Re-Consent

According to the CTRules, the G-KenyaCT, and KEN-14, any change in the ICF due to a protocol modification should be approved by the EC before such changes are implemented. The participant or legal representative/guardian will also be required to re-sign the revised ICF and receive a copy of any amended documentation.

Language Requirements

As stated in the CTRules and the G-KenyaCT, the ICF content should be presented in either English or Kiswahili, and the local spoken language of the area, where applicable. Copies of the English ICF should be submitted to the PPB and to the EC.

Documenting Consent

The CTRules and the G-KenyaCT state that the participant or legal representative/guardian, and the person who conducted the informed consent discussion should sign and personally date the ICF. Where the participant is illiterate, and/or the legal representative/guardian is illiterate, verbal consent should be obtained in the presence of and countersigned by an impartial witness. Before participating in the study, the participant should receive a copy of the signed and dated ICF, and any other written information provided during the informed consent process. The participant or legal representative/guardian should also receive a copy of any updates to the signed and dated ICF.

According to KEN-14, where the participant is illiterate and/or the legal representative/guardian is illiterate, an impartial witness should be present during the entire informed consent discussion. The witness should sign and date the ICF after the following steps have occurred:

• The written ICF and any other written information to be provided to the participant is read and explained to the participant or legal representative/guardian
• The participant or legal representative/guardian have orally consented to the participant’s involvement in the trial, and has signed and dated the ICF, if capable of doing so

Before participating in the study, the participant or legal representative/guardian should receive a copy of the signed and dated ICF.

Waiver of Consent

No information is available.

Based on the NMPA-GCP-No57-2020, the Measures-Ethics, the EC-Guide, the RegEthics, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (CHN-37), the informed consent form (ICF) should include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

• The study purpose, procedures, and duration of the trial
• Any expected risks or discomforts to the participant
• Any expected benefits to the participant; if no benefit is expected, the participant should be informed of this point
• The participant’s responsibilities
• The approximate number of participants involved in the trial
• Those aspects of the trial that are experimental
• Treatment available to the participant as well as important potential risks and benefits associated with this treatment
• The alternative procedure(s) or course(s) of treatment that may be available to the participant, and their important potential benefits and risks
• The nature, form, and extent of compensation for participation
• Any expenses the participant needs to pay to participate in the trial
• The extent to which confidentiality of records identifying the participant will be maintained, and a statement that, when necessary, the sponsor, the ethics committee (EC), the National Medical Products Administration (NMPA), and drug authorities in the provinces, autonomous regions, and municipalities may be required to review participant data
• The scope and method of use of research data and research participants' personal data, and whether sharing and secondary use are carried out
• Any treatment and corresponding compensation the participant can expect to receive in the event of a trial-related injury
• The participant’s rights, including that participation is voluntary, and that the participant can withdraw from the study at any time without penalty or loss of benefits, including medical treatment, to which the participant is otherwise entitled
• Precautions and protective measures for the participant before, during, and after the research
• The foreseeable circumstances and/or reasons under which the participant's participation in the trial may be terminated
• Contact information for the sponsor and investigator in the event of participant problems or injuries related to the trial
• Basic information about the researcher and qualification of research institution
• That records identifying the participant will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the participant’s identity will remain confidential
• Whether the results of the study will be provided to the research participants
• That the participant or the legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the participant’s willingness to continue participation in the trial
• When appropriate, the EC may require the following additional information: whether the research may put the participant at risk but the risk is not currently foreseeable; researchers can terminate a participant’s participation in the study without their consent; new major discoveries during the research will be provided to the participant; and whether there is a potential conflict of interest
• If applicable, how biological samples will be handled

Per the MgmtHumanGen, to collect Chinese human genetic resources (HGR) for a clinical trial, the investigator must provide advance information to the participant on the purpose of collection, the possible health impact, the protection measures of personal privacy, their participation is voluntary, and they have the right to withdraw unconditionally at any time.

Based on the CTRules, the G-KenyaCT, the G-ECBiomedRes, and the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (KEN-14), the informed consent form (ICF) should include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

• Title of the project and that the study involves research and an explanation of its nature and purpose
• The expected duration of the participant’s participation
• The participant’s responsibilities in participating in the trial
• Experimental aspects of the study
• Approximate number of participants involved in the trial
• Trial treatment schedule and the probability for random assignment to each treatment
• Principal investigator(s), institution, and ethics committee (EC) contact information, the person(s) to contact for further information regarding the trial and the rights of trial participants, and whom to contact in the event of trial-related injury
• Any foreseeable risks or discomforts to the participant, and when applicable, to an embryo, fetus, or nursing infant
• Any expected benefits or prorated payment to the participant; if no benefit is expected, the participant should also be made aware of this
• Alternative procedures or treatment that may be available to the participant, including a statement on disclosure of appropriate alternative procedures or courses of treatment that might be advantageous to participants when the research involves non-validated procedures, devices, or therapies
• Compensation and/or medical treatment available to the participant or the family or dependents in the event of a trial-related injury
• Any additional costs to the participant that may result from participation in the research
• The extent to which confidentiality records identifying the participant will be maintained, and if the results of the trial are published, the participant’s identity will remain confidential
• That the Pharmacy and Poisons Board (PPB) will be granted direct access to the participant’s original medical records to verify clinical trial procedures and/or data without violating the participant’s confidentiality
• The details on storage and exportation of biological samples, if applicable
• The details on storage and ownership of personal data
• Information about unblinding, if applicable
• The extent of the investigator’s responsibility, if any, to provide medical services to the participant
• That therapy will be provided free of charge for specified types of research-related injury, including the investigators’ responsibilities in this regard
• That participation is voluntary, the participant may withdraw at any time, and refusal to participate will not involve any penalty or loss of benefits, or reduction in the level of care to which the participant is otherwise entitled
• That the participant will be informed about the dissemination of findings and about any publication of the participant’s medical information, including photographs and pedigree charts
• Foreseeable circumstances under which the investigator(s) may remove the participant without consent
• That the participant or legal representative/guardian will be notified in a timely manner if significant new findings develop during the study which may affect the participant’s willingness to continue
• Consent to incomplete disclosure, for example, if it is necessary to inform participants that some information is being withheld deliberately and the reasons for that decision; an offer to disclose the purpose at the conclusion of the study can be made

Note that per the G-KenyaCT, research must be conducted in accordance with requirements set forth in KEN-14.

In addition, the CTRules delineates that if the potential participant is a child, the ICF must also contain these elements:

• The pathophysiology of the disease or subject of the clinical trial
• The methods of diagnosis
• The currently available treatment or prevention strategy in the pediatric population
• The incidence and prevalence of the disease or subject of the clinical trial in the overall population and in the pediatric population
• The evidence and assumptions on key differences between the disease or subject of the clinical trial in the overall population and the pediatric population

Overview

In accordance with the Declaration of Helsinki (CHN-84), principles set forth in the NMPA-GCP-No57-2020, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (CHN-37), China’s ethics standards safeguard the rights of research participants. Participants also have the right to receive the nationally available standard of health care, and the right to report any trial-related injuries or issues to the investigator(s) and the ethics committee (EC). The RegEthics states that the EC must protect the legitimate rights and interests of the participants, safeguarding their dignity, and promoting the development of biomedical research norms. As indicated in the NMPA-GCP-No57-2020, the EC-Guide, and the RegEthics, a participant’s rights must be clearly addressed in the informed consent form (ICF) and during the informed consent process. (See the Required Elements; Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired sections for additional information regarding requirements for participant rights.) See CHN-26 for an analysis of clinical trial participants’ rights in China.

The Right to Participate, Abstain, or Withdraw

As set forth in the NMPA-GCP-No57-2020, the Measures-Ethics, the EC-Guide, the RegEthics, and CHN-37, the participant or legal representative/guardian should be informed that participation is voluntary, that the participant may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled.

The Right to Information

As delineated in the Measures-Ethics, the EC-Guide, the NMPA-GCP-No57-2020, the RegEthics, and CHN-37, a potential research participant or the legal representative/guardian has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation for participation or injury/treatment, and any significant new information regarding the research study. (See the Required Elements section for more detailed information regarding participant rights.)

The Right to Privacy and Confidentiality

As per the Measures-Ethics, the EC-Guide, the RegEthics, the NMPA-GCP-No57-2020, and CHN-37, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right. The NMPA-GCP-No57-2020 also states that it is the responsibility of the investigator(s) to safeguard the confidentiality of research data to protect the identity and records of research participants.

The Right of Inquiry/Appeal

The Measures-Ethics, the EC-Guide, the NMPA-GCP-No57-2020, and CHN-37 state that the research participant or the legal representative/guardian should be provided with contact information for the investigator(s) and the EC to address trial-related inquiries and/or to appeal against a violation of the participant’s rights. (See the Required Elements section for more detailed information regarding participant rights.)

The Right to Safety and Welfare

The NMPA-GCP-No57-2020 and CHN-37 state that a research participant’s right to safety and the protection of health and welfare must take precedence over the interests of science and society.

Overview

In accordance with the Declaration of Helsinki (KEN-33) principles upheld in the CTRules, the G-KenyaCT, the G-ECBiomedRes, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14), Kenya’s ethical standards promote respect for all human beings and safeguard the rights of research participants. A participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in KEN-14.

The Right to Participate, Abstain, or Withdraw

As set forth in the CTRules, the G-KenyaCT, the G-ECBiomedRes, and KEN-14, a participant or legal representative/guardian should be informed that participation is voluntary, that the participant may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled.

The Right to Information

As delineated in the CTRules, the G-KenyaCT, the G-ECBiomedRes, and KEN-14, a potential research participant or legal representative/guardian has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation for participation or injury/treatment, and any significant new information regarding the research study.

The DPA further indicates that data subjects have a right to:

• Be informed of how their personal data is to be used
• Access their personal data in custody of the data controller (sponsor) or data processor
• Object to the processing of all or part of their personal data
• Correct false or misleading data
• Delete false or misleading data about them

The Right to Privacy and Confidentiality

As per the G-KenyaCT, the G-ECBiomedRes, and KEN-14, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right.

The Right of Inquiry/Appeal

The G-KenyaCT, KEN-14, and the G-ECBiomedRes state that the participant or legal representative/guardian should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries. Further, the G-ECBiomedRes requires that the ethics committee contact information also be provided.

The Right to Safety and Welfare

The G-ECBiomedRes and KEN-14 state that a research participant’s right to safety and the protection of the participant’s health and welfare must take precedence over the interests of science and society. KEN-14 upholds the Declaration of Helsinki (KEN-33). (See the Required Elements and Vulnerable Populations sections for additional information regarding requirements for participant rights.)

The EC-Guide states that during an emergency, clinical studies on human participants must not be conducted without prior review and approval by the ethics committee (EC). Per the NMPA-GCP-No57-2020 and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (CHN-37), in an emergency, if the signed informed consent form (ICF) has not been obtained from the research participant or the legal representative/guardian, or if an effective treatment is lacking, but the investigational product could save the participant’s life, recover health, or alleviate pain, the clinical trial may be conducted. However, the method used on the participant must be explained clearly in the trial protocol as well as the relevant trial documentation, and the EC must approve the protocol in advance. The participant or the legal representative/guardian should be informed about the trial as soon as possible, and consent to continue and other consent should be requested, as appropriate.

During an outbreak of an epidemic, the EC-Guide advises ECs to adhere to the highest scientific and ethical standards for independent review of the research project to ensure balancing of quality and timeliness. The materials provided by the researcher can be simplified according to the situation. The EC should pay special attention to the informed consent process as participants may be improperly exploited due to their obvious vulnerability, especially when it involves high-risk and risk-uncertain research. It should be ensured that participants choose to participate voluntarily and independently after being fully informed and fully understanding the possible risks of research. Research participants or the legal representative/guardian must be allowed to withdraw from research unconditionally at any stage.

See the EC-Guide for additional guidance on the EC review when there is a major epidemic risk.

The G-KenyaCT, the G-ECBiomedRes, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14), make provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by emergencies. Per the G-KenyaCT, research must be conducted in accordance with KEN-14. As delineated in the G-KenyaCT and the G-ECBiomedRes, in an emergency, if the signed informed consent form (ICF) cannot be obtained from the research participant, the consent of the legal representative/guardian should be obtained. If the prior consent of the participant or legal representative/guardian cannot be obtained, the participant’s enrollment should follow measures specified in the protocol, and/or elsewhere, to ensure compliance with ethics committee (EC) and the Pharmacy and Poisons Board (PPB) requirements. The G-ECBiomedRes requires that the principle of clinical equipoise be applied, which essentially means the participant is not any worse off by enrolling.

During a public health emergency, the G-KenyaCT stipulates that the informed consent of participants must be obtained in individuals capable of giving informed consent. The CT-Emrgcy includes safeguards to protect clinical trial participants during a public health emergency, including the recommendation to reconsent if there are amendments as a result of the emergency.

Per KEN-14, in an emergency, if the signed ICF has not been obtained from the participant or legal representative/guardian, or if an effective treatment is lacking but the investigational product could address the participant’s emergency needs, the clinical trial may be conducted. However, the method used on the participant must be explained clearly in the trial protocol, and the EC must approve the protocol in advance. The participant or legal representative/guardian should be informed about the trial as soon as possible, and consent to continue and other consent should be requested, as appropriate.

Overview

As per the EC-Guide, the NMPA-GCP-No57-2020, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (CHN-37), in all Chinese clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. The EC-Guide and the NMPA-GCP-No57-2020 define vulnerable persons as those who are relatively (or absolutely) incapable of safeguarding their interests, and consequently, are usually incapable of giving consent or refusing to give consent due to the restriction on their capacities or freedoms. These populations include people with low socioeconomic status and low education levels. The EC-Guide also defines vulnerability to include the following areas: economic, institutional fragility, cognitive, social, medical treatment, and compliance. The NMPA-GCP-No57-2020 and CHN-37 also include members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include persons in nursing homes, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

The NMPA-GCP-No57-2020, which upholds the principles of the Declaration of Helsinki (CHN-84) and the RegEthics, both require special attention to be provided to those participants who cannot give or refuse to give consent for themselves, and for those who will not benefit personally from the research. As per RegEthics, this population includes children, pregnant women, mentally impaired persons, and people with mental disorders. Also, the Measures-Ethics requires special protection for research participants involving specific groups, such as children, pregnant women, the elderly, persons with intellectual and mental disabilities. In addition, special attention should be paid to studies involving fertilized eggs, embryos, fetuses, or those that may be affected by assisted reproductive technologies.

Note: The EC-Guide clarifies that special protections for vulnerable populations must not mean that they are excluded during the recruitment process. Vulnerable people should also benefit from research and be encouraged to participate in clinical research.

For additional information, see the Children/Minors and Mentally Impaired sections. In addition, see CHN-26 for an analysis of clinical trial participants’ rights in China.

Overview

As per the G-KenyaCT, the G-ECBiomedRes, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14), in all Kenyan clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. Vulnerable populations include those participants with diminished autonomy whose decision to participate in a clinical trial may be unduly influenced by the expectation of benefits associated with participation or by coercion. This may include, but is not limited to, children/minors, pregnant women, neonates, fetuses, medical students, members of the uniformed forces, prisoners, orphans, homeless populations, unemployed, internally displaced persons, economically or educationally disadvantaged persons, marginalized social groups, individuals with terminal illnesses, and the mentally challenged. KEN-14 also includes members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include persons in nursing homes, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in KEN-14.

Elderly Persons

The G-ECBiomedRes defines an elderly/senior citizen as a person who has attained the age of 65 years. Their physical or mental state may affect their ability to make voluntary decisions regarding their participation in research projects. Such research involving elderly/senior citizens must comply with the following requirements:

• Strict adherence to ethical principles
• The risk-benefit ratio must be favorable to the research participant
• The participants must be protected from gross violation of human rights

Persons in Dependent Groups

Per the G-ECBiomedRes, research involving data collection by superiors on their subordinates involves relationships such as employer-employee, teacher-students, supervisor-staff, sponsor-dependent, and parent-children. This relationship impairs independent consent by the participants leading to complacency. Therefore, research involving the superior/subordinate relationships must fulfill the following requirements:

• The superior must strictly follow ethical principles to avoid undue pressure
• Subordinates must be protected from gross violation of human rights
• The trial design must be based on a need-to-know principle and improve the conditions of the participants

Persons in Low-Resource Communities

The G-ECBiomedRes provides the following requirements related to conducting research on participants in low-resource settings:

• Persons in such settings should not be involved in research that could be carried out reasonably well in developed communities
• The research should be responsive to the health needs and priorities of the community in which it is to be implemented
• Undue inducement to participate in the research must be avoided at all costs

Armed Forces

The G-ECBiomedRes stipulates that research involving the members of the armed forces may be vulnerable because of the conditions of their service, which may affect their ability to make voluntary decisions regarding their participation in research. Such research must be conducted to ensure that:

• Participants are protected from gross violations of human rights
• There is strict adherence to ethical principles
• There is at least one (1) member of the ethics committee approving such research who is an enlisted and authoritative member of the armed forces

Terminally Ill

Per the G-ECBiomedRes, research involving participants who are terminally ill with an incurable medical condition are vulnerable. Their state may affect their ability to make voluntary decisions regarding their participation in research. Such research can only be conducted when:

• The objectives of the project(s) cannot be achieved using another non-vulnerable group
• There is strict adherence to ethical principles
• The risk-benefit ratio should be favorable to the research participant

See the Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired sections for additional information about these vulnerable populations.

As per MPL, minors refer to citizens who are under the age of 18.

In accordance with the NMPA-GCP-No57-2020 and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (CHN-37), when the research participant is a child, the informed consent form (ICF) must be signed by the child’s parent/legal guardian. If the child can decide whether to participate, the ICF should also be approved by the child. The age of consent for children and minors is not defined in the currently available regulatory resources. See CHN-26 for an analysis of clinical trial participants’ rights in China.

Per NMPA-No11-2017, clinical trials may be conducted on children depending on existing knowledge of and extrapolation by research results in adults. Drugs that are intended for use in children should be evaluated in the appropriate age group for children and start in the high-age group followed by the low-age group. The EC-Guide stipulates the following conditions when children can participate in research:

• Only when it is shown that the research may be aimed at the prevention and mitigation of serious problems that affect the health and well-being of children
• Research that does not exceed the minimum risk
• Research that moderately exceeds the minimum risk, but is expected to directly benefit the child participants
• Research that moderately exceeds the minimum risk limit, but children may benefit from a population of participants

Per DctrlzCTs-Rare, for decentralized clinical trials of rare diseases, electronic informed consent may be used with children. Since rare diseases often occur in childhood, the use of multimedia interactive modes, such as video, audio, and charts, in the informed consent process will be more conducive to the understanding of child participants and help them to be fully informed.

Assent Requirements

No information is currently available regarding assent requirements for children or minors.

According to the G-KenyaCT, a minor is someone under 18 years of age. As set forth in the G-KenyaCT, the G-ECBiomedRes, and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14), when the research participant is a minor, informed consent should be obtained from the parent/guardian. Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in KEN-14. The informed consent forms, assent forms, and the patient information sheets should be in a language that the parent/guardian clearly understand. All pediatric participants should be fully informed about the trial and its risks and benefits in a language and terms that they are easily able to understand.

Per the G-KenyaCT, a minor should take part in the informed consent procedure in a way tailored to their age and mental maturity. If capable, the participant should sign and personally date the written informed consent. In addition, consent given by pediatric participants should not be considered valid without prior approval by the ethics committee (EC).

The CTRules, the G-ECBiomedRes, and the G-KenyaCT state that a study may only be conducted on minors if several conditions are fulfilled including (Note: Each of the items listed below will not necessarily be found in all sources, which provide overlapping and unique elements):

• Pediatric participants will not be involved in research that might be equally carried out in adults
• The purpose of the research is to generate knowledge relevant to the health needs of children
• The parent/guardian must provide proxy consent and ensure assent has been obtained to the extent of the child’s capabilities. However, if the minor refuses to participate after proxy consent is given, the minor’s refusal must be respected unless there is no other medical alternative from which the minor could benefit
• The risk presented by interventions not intended to benefit the minor is low and commensurate with the importance of the knowledge to be gained
• Interventions that are intended to provide therapeutic benefit are likely to be at least as advantageous to the individual child as any available alternative
• No incentives or financial inducements are given to the participant or parent/guardian except to provide compensation for expenses and loss of earnings directly related to the participation in the trial

Additionally, per the G-KenyaCT, the trial should also address the following considerations:

• Provide useful answers to the study population
• The medicine satisfies a need for the population being studied
• Children are adequately monitored and protected
• If there is no direct benefit to the child, or there is no more than minimal risk to the participant(s)
• Trial results will be published
• End-of-trial treatment provisions will be made

Assent Requirements

As delineated in the G-KenyaCT, before undertaking research involving children, the investigator must ensure that the agreement (assent) of each child has been obtained to the extent of the child’s capabilities, and a child’s refusal to participate or continue in the research must be respected. Assent is defined as a child’s affirmative agreement to participate in research, where the child is below the age of the majority but old enough to understand the proposed research in general, its expected risks and possible benefits, and the activities expected of them as participants. The G-ECBiomedRes provides that in children above seven (7) years and below 18 years where the parent(s)/guardian(s) gives proxy consent, assent must be obtained from the child.

For an example of an accredited EC’s assent requirements, see the Kenyatta National Hospital-University of Nairobi (KNH-UoN) Ethics and Research Committee’s sample minor assent form (KEN-17).

While RegEthics lists pregnant women as a vulnerable population, there are no relevant provisions regarding any special consent procedures for pregnant women, fetuses, or neonates.

Per NMPA-No11-2017, any research studies of pregnant women should include a follow-up evaluation of these participants during pregnancy, as well as the fetuses and the children from that pregnancy. If a research study is intended for lactating women, the researchers should test the secretion of the drug or its metabolites in human milk, if feasible. If lactating women are recruited into a clinical trial, the effects of the drug on their infants should be monitored and, if necessary, followed. Pregnant women should be excluded from any research study if the investigational product is not intended for use during pregnancy. In this case, if a pregnancy occurs during the clinical trial, the study should be terminated and reported to the ethics committee for follow-up and evaluation of the pregnancy, fetus, and child.

In accordance with the NMPA-GCP-No57-2020 and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (CHN-37), informed consent requirements for conducting clinical trials with pregnant or nursing women or fetuses follow the general requirements listed in the Required Elements section. Specifically, the informed consent form should include a statement on the reasonably foreseeable risks or inconveniences to the participant, and when applicable, to an embryo, fetus, or nursing infant.

Per the G-KenyaCT, research must be conducted in accordance with the requirements set forth in the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14). In accordance with KEN-14, informed consent requirements for conducting clinical trials with pregnant or nursing women or fetuses follow the general requirements listed in the Required Elements section. Specifically, the informed consent form should include a statement on the reasonably foreseeable risks or inconveniences to the participant, and when applicable, to an embryo, fetus, or nursing infant.

As per the G-ECBiomedRes, research involving pregnant, lactating, and breastfeeding women may pose compromised long-term outcomes for the child. In addition, potential parent(s) can make decisions on behalf of the fetus(es), embryo(s), and zygote(s).

For fetal, embryo, and zygote(s) cases, research should be limited as follows:

• Cases that present no harm or offer assistance to the life system of the participants
• No procedures should be permitted that are likely to harm them
• A fetus ex-utero and alive, embryo, and zygote must not be involved in research unless it is intended to enhance the life of that fetus, embryo, and zygote or unless the research involves no risk to them

Additionally, the following guidelines must be followed for research involving pregnant, lactating, and breastfeeding women:

• The research carries no more than minimal risk to the fetuses or nursing infants
• Pregnant or nursing women should generally not be clinical trial participants except where such trials are designed to protect or advance the health of the pregnant/nursing women or fetuses/nursing infants, and for which women who are not pregnant or nursing would not be suitable participants
• The justification for such research should be that participants must not be arbitrarily deprived of the opportunity to benefit from investigational drugs, vaccines, or other agents that promise therapeutic or preventive benefits

The NMPA-GCP-No57-2020 and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (CHN-37) list prisoners as a vulnerable population. Per CHN-37, because incarceration could affect their ability to make a voluntary decision regarding participation in research. A research study involving prisoners should ensure that these prospective participants are informed and are given the opportunity to make their own decisions without any interference from a higher authority. The ethics committee must also ensure that the study will be independently monitored to assure the dignity and rights of the prisoners involved in the research. In accordance with the NMPA-GCP-No57-2020 and CHN-37, informed consent requirements for conducting clinical trials with prisoners should follow the general requirements listed in the Required Elements section.

Per the G-ECBiomedRes and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14), prisoners are considered vulnerable because incarceration could affect their ability to make a voluntary decision regarding participation in research. Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in KEN-14. A research study involving prisoners should ensure that these prospective participants are informed and given the opportunity to make their own decisions without any interference or reprisals from a higher authority. The ethics committee must also ensure that the study will be independently monitored to assure the dignity and rights of the prisoners involved in the research.

While the RegEthics lists mentally impaired people as a vulnerable population, there are no relevant provisions regarding any special consent procedures for them. The NMPA-GCP-No57-2020 and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (CHN-37) allow the ethics committee to approve the participation of research participants who are incompetent, or mentally or physically incapable of giving consent under certain conditions. The informed consent form must be signed and dated by the participant’s legal representative/guardian.

Per DctrlzCTs-Rare, for decentralized clinical trials of rare diseases, electronic informed consent may be used with mentally impaired people. For some rare disease patients with cognitive impairment (such as neurodevelopmental dyslexia) or writing disorders (such as primary hereditary dystonia), the legal representative/guardian can help introduce the material to better protect the rights and interests of participants.

As per the G-ECBiomedRes and the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14), an ethics committee (EC) within the relevant institution must approve the participation of adult research participants who are incapable by reason of physical and mental capacity to give consent. Per the G-KenyaCT, research must be conducted in accordance with requirements set forth in KEN-14.

In addition, as delineated in the G-ECBiomedRes, a research study may involve participants with mental incapacities or behavioral disorders under the following conditions:

• Such research could not be carried out equally well with individuals who are in possession of their full mental faculties
• The knowledge gained would be relevant to the health needs of persons with mental or behavioral disorders
• The participant’s consent has been obtained to the extent of the participant’s capabilities, and a prospective participant’s refusal to participate is always respected
• In the case of incompetent individuals, informed consent shall be obtained from a legal guardian or other duly authorized person
• The degree of risk attached to the intervention not intended to benefit the individual participant is low and commensurate with the importance of knowledge to be gained
• Interventions that are intended to provide therapeutic benefit are likely to be at least as advantageous to the individual participant as any alternative

As delineated in the NMPA-GCP-No57-2020, investigational products (IPs) are defined as experimental and reference drugs used in a clinical trial.

The International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (CHN-37) define an IP as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial. This includes a product with a marketing authorization when it is used or assembled (formulated or packaged) in a different way from the approved form, when used for an unapproved indication, or when used to gain further information about an approved use.

The G-KenyaCT defines an investigational product (IP) as any pharmaceutical product, including a new product or existing product for a new indication, in the form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.

Manufacturing

According to the DAL and the NMPA-No28-2020, the National Medical Products Administration (NMPA) is responsible for authorizing the manufacture of investigational products (IPs) in China. See CHN-11 for an analysis of the authorization procedure for manufacturing drugs in China.

Per the DAL and the NMPA-No28-2020, the holder of the drug registration certificate must obtain a drug production license (found at NMPA-No72-2019) to produce a drug or entrust a pharmaceutical production enterprise to produce it. If an entrusted production enterprise is used, the drug registration certificate holder and the entrusted production enterprise must sign an entrustment agreement and a quality agreement. Blood products, narcotic drugs, psychotropic drugs, medical toxic drugs, and pharmaceutical precursor chemicals cannot be entrusted to a pharmaceutical production enterprise for production, unless otherwise stipulated by the NMPA. The DAL states that the drug production license must indicate the validity period and production scope, and must be reviewed and reissued upon expiration. Per the NMPA-No28-2020, a drug production license is valid for five (5) years; an application for a new drug production license must be submitted to the original issuing authority six (6) months before the expiration.

As delineated in the DAL and the NMPA-No28-2020, the following conditions must be met for drug manufacturing:

• Pharmacy technicians, engineering, technical personnel, and skilled workers have been qualified according to law
• Sanitary plants and facilities are compatible with the production of pharmaceuticals
• Institutions, personnel, and equipment are capable of quality management and inspection of the produced drugs
• Rules and regulations are in place to ensure the quality of pharmaceuticals and compliance with quality management requirements

Specific guidance on drugs manufactured for clinical trials is provided in NMPA-No43-2022 (an annex to the NMPA-GMP), which states that the preparation and quality control of drugs for clinical trials must follow the requirements in the NMPA-GMP; minimize the risks of contamination, cross-contamination, confusion, and errors in the manufacturing process; and ensure the quality of clinical trial IPs to protect the safety of clinical trial participants. See NMPA-No43-2022 for detailed manufacturing requirements, including the quality management system, personnel, facilities and equipment, material management, file management, and management of the control drug.

The NMPA-GCP-No57-2020 specifies that the manufacture of clinical trial drugs must meet the relevant requirements for quality management. See NMPA-GMP, NMPA-No43-2022, NMPA-No28-2020, NMPA-No13-2015, and NMPA-No28-2016 for guidance on the quality management system during manufacturing. Per the DRR and the NMPA-No28-2020, the Center for Drug Evaluation (CDE) makes a risk-based decision on whether to initiate an on-site inspection of drug production based on the registered varieties, processes, facilities, and previous acceptance verification. However, on-site inspections must be conducted for innovative drugs, improved new drugs, and biological products.

The International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (CHN-37) also requires IPs to be manufactured, handled, and stored in accordance with applicable good manufacturing practices and used in accordance with the approved protocol.

Import

The DAL provides that prior to IP import, an NMPA import drug license must be obtained for each IP. Per CHN-18, before each import, the import agent must file for a record with the local agency at the port of entry, which issues a customs clearance notice of imported drugs and port inspection notice of imported drugs. According to CHN-28, importers must apply for the drug import license via the China International Trade Single Window online platform (CHN-2). For IP shipments, only a party authorized under the corresponding clinical trial approval can register and apply for the drug import license.

Per NMPA-No75-2020, there is a one-time fee of 2,000 Yuan for the import of drugs.

Pursuant to the NMPA-No35-2017, researchers can conduct Phase I of multi-regional clinical trials (MRCT) of imported IPs and therapeutic biological products (excluding vaccines) simultaneously in China.

As per NMPA-No52-2018, clinical trial and drug registration applications for imported new drugs or therapeutic biological products using trial data generated entirely overseas do not need to be registered first in their own country in order to enter China. This removes the need to conduct local clinical trials in addition to existing overseas research. Overseas clinical trial data may be acceptable for direct China registration provided that:

• The data is reliable, authenticated, and complies with CHN-37
• The data can assess the efficacy and safety for the target indication
• There are no ethnic sensitivities to Chinese local populations influencing efficacy and safety
• The data meets China drug registration requirements

See the NMPA-No52-2018 for additional details on the review and approval of overseas clinical trial data. For more information on application requirements, see the Submission Process and Submission Content sections.

Per NMPA-No230-2015 and CHN-18, the NMPA will prioritize the review and approval of foreign innovative drugs manufactured in China and drugs manufactured at a United States (U.S.) or European Union facility, and are simultaneously under review for marketing authorization by the U.S. Food and Drug Administration or the European Medicines Agency.

Please note: China is party to the Nagoya Protocol on Access and Benefit-sharing (CHN-30), which may have implications for studies of IPs developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see CHN-55.

Manufacturing

According to the PPA and the G-KenyaCT, the Pharmacy and Poisons Board (PPB) is responsible for authorizing the manufacture of all drug products, including investigational products (IPs) in Kenya. Per the CTRules and the G-KenyaCT, an IP must be manufactured in accordance with the requirements of good manufacturing practice (GMP). The CTRules requires a sponsor to immediately notify the PPB in writing when a pharmaceutical or chemical alteration may affect the quality, safety, or efficacy of the IP product during an ongoing clinical trial. The G-KenyaCT states that the sponsor must submit the IP dossier directly to the PPB or may submit it through the principal investigator. The IP dossier must be prepared as per the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (KEN-14), which is required per G-KenyaCT. The manufacture of IPs may be subject to GMP inspection by the PPB in the same way as in the case of marketed drug products. See the G-KenyaCT for detailed chemistry and manufacturing information to be provided to the PPB if the IP has not been registered with the PPB.

KEN-14 also requires IPs to be manufactured, handled, and stored in accordance with applicable GMPs and used in accordance with the approved protocol.

Per the PPA, the PPB is authorized to regulate the manufacturing of medicine, including:

• Ensure that all medicinal products manufactured in, imported into, or exported from the country conform to prescribed standards of quality, safety, and efficacy
• Ensure that the personnel, premises, and practices employed in the manufacture, storage, marketing, distribution, and sale of medicinal substances comply with the defined codes of practice and other prescribed requirements
• Grant or revoke licenses for the manufacture, importation, exportation, distribution, and sale of medicinal substances
• Inspect and license all manufacturing premises, importing and exporting agents, wholesalers, distributors, pharmacies (including those in hospitals and clinics), and other retail outlets

See the KenyaGMP, for PPB’s compilation of recommended World Health Organization GMP guidelines to help comply with GMP requirements and prepare for an inspection, including for manufacture of IPs.

Import

Per the PPA and the ImpExp, the PPB is authorized to regulate the import and export of health products and technologies, including IPs. As per the ImpExp and the G-KenyaCT, to obtain an import permit for a clinical trial, the sponsor or investigator must submit an application online to the Kenya Trade Network Agency’s Kenya TradeNet Single Window System (KEN-28). The following documents must be submitted (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

• The proforma invoice or invoice
• The ethics committee favorable opinion letter
• The Expert Committee on Clinical Trials approval letter from the PPB
• Registration of the institution where the research is being undertaken

The G-KenyaCT states that the sponsor must submit to the PPB a copy of the endorsed clinical trial import permit and/or evidence of delivery to the approved investigator(s)/trial center(s) on importation and supply of each consignment of the product. The product must only be supplied to the investigator(s) at the trial site(s) named in the clinical trial import license application for the purpose and use as stated in the said application. Prior PPB notification and approval is required for changes in the investigator, trial site, or protocol. The sponsor must inform PPB of any change in information, or any information received that casts doubt on the continued validity of the data, which was submitted with, or in connection with the application for the import permit. The sponsor must also inform the PPB of any decision to discontinue the trial to which the permit relates and state the reason for the decision. See KEN-8 for additional details on the procedures for obtaining an import license.

Per the CTRules, the import of an IP must comply with the applicable regulatory requirements to ensure integrity and accountability of the products. The PPB may revoke or suspend an import permit if the IP was manufactured in conditions not consistent with GMP; if the clinical trial was discontinued; or if the sponsor provided false information.

Please note: Kenya is party to the Nagoya Protocol on Access and Benefit-sharing (KEN-3), which may have implications for studies of IPs developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see KEN-15.