Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
Submission Content
Timeline of Review
Trial Initiation
Safety Reporting
Progress Reporting
Sponsorship
Definition of Sponsor
Trial Authorization
Insurance
Compensation
Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
Documentation Requirements
Required Elements
Compensation Disclosure
Participant Rights
Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
Prisoners
Mentally Impaired
Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
Labeling & Packaging
Product Management
Specimens
Definition of Specimen
Import & Export
Consent for Specimens
China
QUICK FACTS
Clinical trial application languageStandard Chinese
Parallel regulatory and ethical review permittedUnspecified
Clinical trial registration requiredYes
In-country sponsor presence/representation requiredNo
Age of minorsUnspecified
Specimens export allowedYes
Regulatory Authority > Regulatory Authority
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
Clinical trials must be conducted for any drug to be registered in China. Drug registration is divided into three categories: (1) domestic new drugs, (2) domestic generic drugs, and (3) imported drugs. The clinical trial application review and approval process is determined by the drug category in which an applicant chooses to register. As per the PDR and the SCNotice-CFDA (also see Additional Resource (A)), the China Food and Drug Administration (CFDA) (formerly the State Food and Drug Administration (SFDA)) is the regulatory authority responsible for clinical trial oversight, approval, and inspections in China. The CFDA grants permission for clinical trials to be conducted in China in accordance with the provisions of the DAL and the RegImplemDAL.

As delineated in the SCNotice-CFDA (also see Additional Resource (A)), effective March 2013, the State Council of the People's Republic of China received approval from the National People’s Congress to restructure the SFDA and create the CFDA. The CFDA is a full ministry agency reporting directly to the State Council. All of the SFDA’s previous regulatory functions relating to drugs, medical devices, health food, cosmetics, and food safety have been merged into the new CFDA. According to the CFDA (see Additional Resource (D)), the primary centers involved in the clinical trial application and drug registration approval process include:

  1. National Institutes for Food and Drug Control (NIFDC)
  2. Chinese Pharmacopoeia Commission (CPC)
  3. Center for Drug Evaluation (CDE)
  4. Center for Drug Certification (CDC)
  5. National Committee on the Assessment of the Protected Traditional Chinese Medicinal Products (NCAPTCMP)/Center for Health Food Evaluation (CHFE)
  6. Center for Drug Reevaluation (CDR)/National Center for ADR Monitoring
  7. Center for Medical Device Evaluation (CMDE)


Additional affiliated centers are discussed in Additional Resource (I). However, the CDE and the NIFDC are the centers that play a pivotal role in the clinical trial application review and approval process, as discussed in the Regulatory Authority topic, Scope of Review subtopic.

Contact Information
China Food and Drug Administration
26 Xuanwumen Xidajie
Xicheng District
Beijing 100053
P.R. China

Phone:+86-10-68313344
Website: http://www.sfda.gov.cn
Fax: +86-010-68310909
Email: inquires@sda.gov.cn

The CFDA website does not provide application submission address information on its website. However, the G-CTImprtChem and Additional Resource (J) state that clinical trial applications and correspondence should be mailed to:

Application Submissions Contact Information
CFDA Administrative Acceptance Service Center
A38, Beilishi Road
Xicheng District
Beijing 100810
P.R. China
Phone: +86-010-68315572
Fax: +86-010-88330265
Email: slzx@sfda.gov.cn

ADDITIONAL RESOURCES

(A) (Report) Provisions of CFDA Responsibilities and Departments (June 14, 2013)
Global Agricultural Information Network, USDA Foreign Agricultural Service

(B) (Website) China Food and Drug Administration – About CFDA (Current as of April 30, 2015)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

(C) (Website) China Food and Drug Administration – Contact CFDA (Standard Chinese/Zhōngwén) (Current as of April 30, 2015)
China Food and Drug Administration, State Council of the People’s Republic of China

(D) (Website)  China Food and Drug Administration – Affiliated Organizations (Current as of April 30, 2015)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

(E) (Website) China Food and Drug Administration – Department of Drug and Cosmetics Registration (Department of TCMs & Ethno-Medicines Supervision) (Department of TCMs & Ethno-Medicines Supervision) (Current as of April 30, 2015)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

(F) (Website) Application and Approval Procedure for Clinical Trials (May 24, 2004)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

(G) (Website) Application and Approval Procedure for Imported Drugs (1) ( June 11, 2004)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

(H) (Article) China Reorganizes and Appoints a New Commissioner (March 25, 2013)
E-Alert Food & Drug, Covington and Burling

(I) (Article) Drug Regulatory Bodies: Key Role Players in Different Regions (2012)
Singh, Kamaljit S., Bhambhu, Vikas K., Arora, Saahil, and Murthy, RSR
American Journal of PharmTech Research

Relevant Section: Vol. 2(3), Pages 194-195

(J) (Article) China’s State Food and Drug Administration Discusses Drug Applications: A Q &A with Officers of the Departments of State Food and Drug Administration, China, moderated by Ji Xie (November 2, 2010)
Pharmaceutical Technology

Relevant Section: Pages 66-70

REQUIREMENTS

(1) (Legislation) Provisions for Drug Registration (Order No. 28) (PDR) (Standard Chinese/Zhōngwén) (Effective Date: October 1, 2007)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter I (Articles 5 and 8), Chapter II (Articles 11 and 12), Chapter III (Articles 30, 31, 36, and 37), Chapter IV (Section 1), Chapter V, Chapter VI (Section 1), and Chapter X

(2) (Regulation) Notice of the State Council Concerning Printing and Circulation of the Provisions of CFDA Responsibilities, Departments and Staffing (SCNotice-CFDA – English, unofficial translation) (Standard Chinese/Zhōngwén)
State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: II and III

(3) (Legislation) Drug Administration Law of the People’s Republic of China (Order No. 45) (DAL) (Effective Date: December 1, 2001)
National People’s Congress, People’s Republic of China

Relevant Sections: Chapter I (Articles 5 and 6) and Chapter V (Article 29)

(4) (Regulation) Regulations for Implementation of the Drug Administration Law of the People’s Republic of China (Decree No. 360) (RegImplemDAL) (Effective Date: September 15, 2002)
State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter V (Articles 29 and 30)

(5) (Guidance) Principles and Procedures for Drug Evaluation and Review (CDEProcs) (April 13, 2011)
Center for Drug Evaluation, China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter I (Article 3) and Chapter II (Sections 1 and 2)

(6) (Guidance) Approval for Clinical Trials of Imported (incl. from Hong Kong, Macao and Taiwan) Chemicals (G-CTImprtChem) (December 6, 2013)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: VII, VIII, and IX

Regulatory Authority > Scope of Assessment
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
In accordance with the PDR, the DAL, the RegImplemDAL, and the SCNotice-CFDA (also see Additional Resource (A)), the China Food and Drug Administration (CFDA) (formerly the State Food and Drug Administration (SFDA)) is responsible for reviewing and approving clinical trial applications for all new drugs, generic drugs, and imported drugs to be registered in China. The clinical trial application review and approval process is determined by the drug category in which an applicant chooses to register. The scope of the CFDA’s assessment includes Phase I through Phase IV clinical trials and bioequivalence studies. As stated in the PDR, the CFDA’s approval of a clinical trial application is dependent upon obtaining proof of the ethics committee’s (EC) approval. The PDR and Additional Resource (H) state that a Chinese legal entity must submit the drug registration application. Clinical trial applications are also considered to be drug registration applications. Overseas drug manufacturers without legal representation in China must apply for product registration through an agent with professional knowledge and familiarity with Chinese laws and regulations.

Clinical Trial Review Process
As delineated in the PDR, the CDEProcs, and the G-CTImprtChem, the CFDA’s Department of Drug Registration is responsible for conducting an administrative review of a clinical trial application, and then forwarding the submission to the Center for Drug Evaluation (CDE) for technical review. The CDE is responsible for evaluating chemistry drugs, traditional Chinese medicines, and biologic products to assess whether the safety and effectiveness data provided in the clinical trial application justifies CFDA approval. The CDE’s recommendations are reviewed by the CFDA, which is authorized to approve the application. Additional Resources (D), (E), (F) and (G) also provide useful information on the CFDA’s clinical trial application review and approval process.

As per the PDR and the G-CTImprtChem, while the CDE conducts its technical review, the National Institutes for Food and Drug Control (NIFDC) will conduct sample testing, or arrange for one of the drug testing institutes in the provinces, autonomous regions, and municipalities directly under the Central Government, to conduct sample testing concurrently to verify the quality of the drug products to be used in the study. (See the Clinical Trial Lifecycle topic, Submission Process subtopic for detailed submission requirements.)

ADDITIONAL RESOURCES

(A) (Report) Provisions of CFDA Responsibilities and Departments (June 14, 2013)
Global Agricultural Information Network, USDA Foreign Agricultural Service

(B) (Website) Application and Approval Procedure for Clinical Trials (May 24, 2004)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

(C) (Website) Application and Approval Procedure for Imported Drugs (1) (June 11, 2004)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

(D) (Article)  China’s State Food and Drug Administration Discusses Drug Applications: A Q &A with Officers of the Departments of State Food and Drug Administration, China, moderated by Ji Xie (November 2, 2010)
Pharmaceutical Technology

Relevant Section: Pages 66-70

(E) (Article) Drug Regulatory Bodies: Key Role Players in Different Regions (2012)
Singh, Kamaljit S., Bhambhu, Vikas K., Arora, Saahil, and Murthy, RSR
American Journal of PharmTech Research

Relevant Section: Vol. 2(3), Pages 194-195

(F) (Article) Overview of Drug Evaluation System in China (March 18, 2010)
Lu, Dong and Huang, Wenlong
Scientific Research and Essays

Relevant Section: Vol. 5(6), Pages 514-518

(G) (Website) Overview of Chinese Regulatory Framework (Current as of April 30, 2015)
Hangzhou Tigermed Consulting, People’s Republic of China

(H) (Guideline) Importing Pharmaceutical Products to China (July 2014)
EU SME Centre, Beijing, China

Relevant Sections: Imported Drugs Need Pre-market Approval Before Entering the Chinese Market; Biological Products Registration; Annexes 2 and 3; and Links to the Chinese Administration Webpages

REQUIREMENTS

(1) (Legislation) Provisions for Drug Registration (Order No. 28) (PDR) (Standard Chinese/Zhōngwén) (Effective Date: October 1, 2007)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter I (Articles 5 and 8), Chapter II (Articles 11 and 12), Chapter III (Articles 30, 31, 36, and 37), Chapter IV (Section 1), Chapter V, Chapter VI (Section 1), and Chapter X

(2) (Legislation) Drug Administration Law of the People’s Republic of China (Order No. 45) (DAL) (Effective Date: December 1, 2001)
National People’s Congress, People’s Republic of China

Relevant Sections: Chapter I (Articles 5 and 6) and Chapter V (Article 29)

(3) (Regulation) Regulations for Implementation of the Drug Administration Law of the People’s Republic of China (Decree No. 360) (RegImplemDAL) (Effective Date: September 15, 2002)
State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter V (Articles 29, 30, and 36)

(4) (Regulation) Notice of the State Council Concerning Printing and Circulation of the Provisions of CFDA Responsibilities, Departments and Staffing (SCNotice-CFDA – English, unofficial translation) (Standard Chinese/Zhōngwén)
State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: II and III

(5) (Guidance) Principles and Procedures for Drug Evaluation and Review (CDEProcs) (April 13, 2011)
Center for Drug Evaluation, China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter I (Article 3) and Chapter II (Sections 1 and 2)

(6) (Guidance) Approval for Clinical Trials of Imported (incl. from Hong Kong, Macao and Taiwan) Chemicals (G-CTImprtChem) (December 6, 2013)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: VIII, IX and XIII

Regulatory Authority > Regulatory Fees
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
As per the G-CTImprtChem, the China Food and Drug Administration (CFDA) charges an application fee of 45,300 RMB or $7,258 USD to review and approve imported drug applications.

No information is currently available regarding taxes and fees associated with submitting a clinical trial application for new drugs or generic drugs to the CFDA.

For further guidance on fees associated with submitting supplementary applications and registering renewals for imported drugs and more, please refer to Additional Resource (A).

EC Fees
No relevant provisions.

ADDITIONAL RESOURCES

(A) (Website) China Food and Drug Administration – Regulatory Guide - Drugs (Current as of April 30, 2015)
China Food and Drug Administration, State Council of the People's Republic of China, People’s Republic of China

REQUIREMENTS

(1) (Guidance) Approval for Clinical Trials of Imported (incl. from Hong Kong, Macao and Taiwan) Chemicals (G-CTImprtChem) (December 6, 2013)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Section: IV

Ethics Committee > Ethics Committee
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
China has a decentralized process for the ethical review of clinical trial applications, and requires institutional level ethics committee (EC) approval for each trial site. China’s ethical review process is implemented through a three-tiered framework consisting of a national EC, provincial ECs, and institutional level ECs. As delineated in the RegEthics, the National Health and Family Planning Commission (NHFPC) of the People’s Republic of China's EC, established in 1998, is responsible for managing ECs nationwide, for drafting regulations, and for developing policies relating to ethical review. The provincial, autonomous regional, and municipal health authorities also have ECs set up under their own administration. The provincial, autonomous regional, and municipal level ECs directly supervise and manage institutional ECs. They also provide policy-making advice, organize ethical reviews for research projects upon request, and guide and monitor ethical reviews conducted by institutional ECs.

Each institution that conducts biomedical research is required to have an EC that is responsible for reviewing clinical trial applications. In addition, with the October 2014 passage of the NHFPC-ClinProjMgmt (website in Chinese), medical institutions must now 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, a Clinical Study Administration Division, to handle daily project administration. For detailed requirements, see the NHFPC-ClinProjMgmt (website in Chinese), and Additional Resources (A) and (B).

EC Composition
The RegEthics, the EthicsGuide, and the PRC-GCPs, state institutional ECs must have at least five (5) members representing a balanced gender composition. 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 ethical review. However, no strict parameters are required to be followed. In areas where minority ethnic groups reside, the institution should consider including members of those groups on the EC.

The EC composition should include a chairperson and several vice chairpersons, all of whom are elected by committee members. The number of vice chairpersons is not specified in the guidelines. The EC may also appoint or invite an independent consultant on an as needed basis for research projects.

ECs should not accept any research project applications that are against national laws and regulations. In addition, the EC should refuse to review any projects in which they have a conflict of interest.

Terms of Reference, Review Procedures, and Meeting Schedule
As per the RegEthics, the EthicsGuide, and the PRC-GCPs, each institution must have written SOPs, including a process to be followed for conducting reviews. EC members should agree to disclose their names, occupations, and affiliations, and to sign the reviews, confidentiality agreements, and a conflict of interest declaration. The term of each EC member 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. Written records of all meetings and resolutions should be preserved for five (5) years following the completion of a clinical trial.

ADDITIONAL RESOURCES

(A) (Article) China Aims to Tighten Supervision Over Clinical Studies (October 31, 2014)
Wang, Katherine
Ropes & Gray Alert

(B) (Article) China Sets New Requirements for Hospitals Running Clinical Trials (November 10, 2014)
Brennan, Zachary
Outsourcing-Pharma.com

(C) (Presentation) Challenges Regarding the Research Ethics in China (January 27, 2012)
Hu, Qingli
World Health Organization – Western Pacific Region

(D) (Article) Bioethics in China: Although National Guidelines are in Place, their Implementation Remains Difficult (2006)
Hennig, Wolfgang
EMBO Reports

Relevant Sections: Vol 7(9), Pages 850-854

(E) (Article) China Taking the Right Steps in Bioethics (May 18, 2007)
Renzong, Qiu
SciDev.Net

REQUIREMENTS

(1) (Guidance) Ethical Review of Biomedical Research Involving Human Subjects (Trial Implementation) (RegEthics – English, unofficial version) (Standard Chinese/Zhōngwén) (January 11, 2007)
Ministry of Health of the People’s Republic of China, People’s Republic of China

Relevant Sections: Introduction, Chapter 2 (Articles 5, 6, 7, and 8), and Chapter 3 (Articles 19 and 21)

(2) (Guidance) Guiding Principles for the Ethical Review of Clinical Trials of Drugs (EthicsGuide – English, unofficial translation) (Standard Chinese/Zhōngwén) (November 2, 2010)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 2 (Articles 5, 6, 8, 9, 10, and 12) and Chapter V (Article 22)

(3) (Guidance) China Good Clinical Practice (PRC-GCPs, English – unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 3 (Articles 9 and 11)

(4) (Regulation) Administrative Measures for the Clinical Study Projects of Medical Institutions (NHFPC-ClinProjMgmt - Standard Chinese/Zhōngwén) (Effective October 16, 2014) National Health and Family Planning Commission, China Food and Drug Administration, Administration of Traditional Chinese Medicine

Relevant Sections: Chapters I, II, III, IV, V, and VI

Ethics Committee > Scope of Review
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
According to the RegEthics, the EthicsGuide, and the PRC-GCPs, 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.

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 Informed Consent topic, and the subtopics of Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired for additional information about these populations). The EC is also 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.

Role in Clinical Trial Approval Process
As per the RegEthics, the EthicsGuide, the PRC-GCPs, the PDR, the DAL, and the RegImplemDAL, the China Food and Drug Administration (CFDA) and the EC must approve a clinical trial application prior to a sponsor initiating a clinical trial. The PRC-GCPs also states that the EC must review and approve any protocol amendments prior to those changes being implemented.

As delineated in the EthicsGuide, if a multicenter clinical trial is being conducted, the first institutional EC to review the protocol may collaborate with the subsequent participating ECs during the protocol review process. However, the participating ECs have the power to approve or disapprove the research conducted in their own institutions.

There is no stated expiration date for an EC approval in the RegEthics, the EthicsGuide, the PRC-GCPs, the PDR, the DAL, or the RegImplemDAL.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) Ethical Review of Biomedical Research Involving Human Subjects (Trial Implementation) (RegEthics – English, unofficial version) (Standard Chinese/Zhōngwén) (January 11, 2007)
Ministry of Health of the People’s Republic of China, People’s Republic of China

Relevant Sections: Introduction, Chapter 1, Chapter 2 (Article 9), Chapter 3 (Articles 14, 19, and 20), and Chapter V (Article 31)

(2) (Guidance) Guiding Principles for the Ethical Review of Clinical Trials of Drugs (EthicsGuide – English, unofficial translation) (Standard Chinese/Zhōngwén) (November 2, 2010)
China Food and Drug Administration, People’s Republic of China

Relevant Sections:
Chapter I (Articles 1 and 2), Chapter III (Articles 10 and 13), Chapter IV (Article 18), Chapter V (Articles 28 and 30), Chapter VI (Article 34), and Appendix 1

(3) (Guidance) China Good Clinical Practice (PRC-GCPs, English – unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Sections:
Chapter 1 (Articles 1 and 4), Chapter 3 (Articles 8, 9, 12, and 14), Chapter 6 (Articles 32, 35, and 43), and Appendix 1

(4) (Legislation) Provisions for Drug Registration (Order No. 28) (PDR) (Standard Chinese/Zhōngwén) (Effective Date: October 1, 2007)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter I (Article 5), Chapter III (Article 30 and 37), Chapter IV (Article 55), Chapter V (Articles 81 and 82), and Chapter VI (Articles 92, 93, and 94)

(5) (Legislation) Drug Administration Law of the People’s Republic of China (Order No. 45) (DAL) (Effective Date: December 1, 2001)
National People’s Congress, People’s Republic of China

Relevant Section: Chapter V (Article 29)

(6) (Regulation) Regulations for Implementation of the Drug Administration Law of the People’s Republic of China (Decree No. 360) (RegImplemDAL) (Effective Date: September 15, 2002)
State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter V (Articles 29 and 30)

Ethics Committee > Ethics Committee Fees
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Ethics Committee > Authorizing Body
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
The RegEthics states that all biomedical research institutions in China should establish their own ethics committee(s) (ECs). While there are currently no regulations formally requiring ECs to obtain accreditation, effective 2005, the China Food and Drug Administration (CFDA) provides a list of qualified drug clinical trial institutions accredited by the CFDA (see Additional Resource (A)).

As delineated in the RegEthics, while there is no regulatory requirement for ECs to obtain accreditation from the National Health and Family Planning Commission of the People’s Republic of China's (website in English and Chinese) EC, this committee provides policy and guidance that must be followed by ECs nationwide.

ADDITIONAL RESOURCES

(A) (Website) SFDA Issues the No.1 Announcement of Drug Clinical Trial Institution Qualification (February 7, 2005)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

(B) (ebook) Global Clinical Trials: Effective Implementation and Management (June 6, 2011)
Chin, Richard and Bairu, Menghis, eds., Academic Press

Relevant Section: Chapter 9, (Section 9.4.2.)

(C) (Presentation) Challenges Regarding the Research Ethics in China (January 27, 2012)
Hu, Qingli
World Health Organization – Western Pacific Region

(D) (Article) China’s State Food and Drug Administration Discusses Drug Applications: A Q &A with Officers of the Departments of State Food and Drug Administration, China, moderated by Ji Xie (November 2, 2010)
Pharmaceutical Technology

Relevant Section: Pages 66-70

REQUIREMENTS

(1) (Guidance) Ethical Review of Biomedical Research Involving Human Subjects (Trial Implementation) (RegEthics – English, unofficial version) (Standard Chinese/Zhōngwén) (January 11, 2007)
Ministry of Health of the People’s Republic of China, People’s Republic of China

Relevant Section: Chapter 1 (Article 6)

Clinical Trial Lifecycle > Submission Process
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
According to the PRC-GCPs, the PDR, the DAL, the RegImplemDAL, and the G-CTImprtChem, the China Food and Drug Administration (CFDA) requires the sponsor to obtain CFDA approval and ethics committee (EC) approval of a clinical trial application. As stated in the PDR the CFDA’s approval of a clinical trial application is dependent upon obtaining proof of the EC’s approval.

Each EC has its own required submission procedures, which can differ significantly regarding the application format and number of copies.

Delivery Address for Clinical Trial Application
The CFDA website does not provide application submission address information on its website. However, the G-CTImprtChem and Additional Resource (C) state that clinical trial applications and correspondence should be mailed to:

CFDA Administrative Acceptance Service Center
A38, Beilishi Road
Beijing 100810
People’s Republic of China
Email: slzx@sfda.gov.cn

Assembly and Number of Copies
According to Additional Resource (C), applicants submitting an application for approval of a new, generic, or imported drug must submit an electronic file using software provided by CFDA (email: slzx@sfda.gov.cn). Both the electronic files and a hard copy of the application must be submitted to the CFDA Administrative Acceptance Service Center (website Chinese). The CFDA Administrative Acceptance Service Center provides links to download and submit applications, and to check the status of an application.

As per the G-CTImprtChem, applicants must submit two (2) complete sets of dossiers to apply for approval of an imported drug (at least one (1) set is in the original and one (1) set of review documents in hard copy shall be submitted for the registration application). In addition, four (4) application forms (one (1) in the original and three (3) in hard copy) must be separately put into each dossier set (the original application form and a hard copy shall be put in the original dossier set). All of the dossier documents must be printed or copied on A4 size paper. For detailed dossier requirements for imported drug applications, see the G-CTImprtChem.

Clinical Trial Application Language Requirements
The G-CTImprtChem and Additional Resources (C) and (D) state that all applications and supporting data submitted to the CFDA are required to be in Chinese.

ADDITIONAL RESOURCES

(A) (Website) Application and Approval Procedure for Clinical Trials (May 24, 2004)
China Food and Drug Administration, State Council of the People's Republic of China, People’s Republic of China

(B) (Website) Application and Approval Procedure for Imported Drugs (1) (June 11, 2004)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

(C) (Article) China’s State Food and Drug Administration Discusses Drug Applications: A Q &A with Officers of the Departments of State Food and Drug Administration, China, moderated by Ji Xie (November 2, 2010)
Pharmaceutical Technology

Relevant Section: Pages 66-70

(D) (Presentation) Overview of Good Clinical Trial Regulations in India, China, and Russia (June 21, 2009)
Mehra, Munish and Vakharia, Shehnaz K.
Drug Information Association 45th Annual Meeting

Relevant Section: Pages 30-46

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 3 (Articles 10 and 11), Chapter 6 (Article 36), and Appendix 2 (1)

(2) (Legislation) Provisions for Drug Registration (Order No. 28) (PDR) (Standard Chinese/Zhōngwén) (Effective Date: October 1, 2007)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter I (Article 5), Chapter III (Article 30 and 37), Chapter IV (Article 55), Chapter V (Articles 81 and 82), and Chapter VI (Articles 92, 93, and 94)

(3) (Legislation) Drug Administration Law of the People’s Republic of China (Order No. 45) (DAL) (Effective Date: December 1, 2001)
National People’s Congress, People’s Republic of China

Relevant Section: Chapter V (Article 29)

(4) (Regulation) Regulations for Implementation of the Drug Administration Law of the People’s Republic of China (Decree No. 360) (RegImplemDAL) (Effective Date: September 15, 2002)
State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter V (Articles 29 and 30)

(5) (Guidance) Approval for Clinical Trials of Imported (incl. from Hong Kong, Macao and Taiwan) Chemicals (G-CTImprtChem) (December 6, 2013)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: VI, VII, VIII, IX, X, and XIII

Clinical Trial Lifecycle > Submission Content
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
In accordance with the PRC-GCPs, the PDR, the DAL, the RegImplemDAL, and the G-CTImprtChem, the sponsor must apply to the China Food and Drug Administration (CFDA) and an ethics committee (EC) to conduct a clinical trial for all drugs that will be registered in China. The CFDA’s approval of a clinical trial application is dependent upon obtaining proof of the EC’s approval. The PDR and Additional Resource (A) also state that a Chinese legal entity must submit the drug registration application. Clinical trial applications are also considered to be drug registration applications. Overseas drug manufacturers without legal representation in China must apply for product registration through an agent with professional knowledge and familiarity with Chinese laws and regulations.

CFDA Requirements
As per the PDR and the G-CTImprtChem, the following documentation must be submitted to the CFDA as part of the approval process:

  • Application Form for Drug Registration (new drug, generic drug, or imported drug)
  • Classification of registration (Chinese medicine, chemical drug, therapeutic biological product, or preventive biological product)
  • Drug information (drug name, chemical name, raw materials, dosage type, package specifications, shelf life, active ingredients, excipients)
  • Other information (patent, drug protection, approval of drug in foreign countries)
  • Applicant information (sponsor, manufacturer, packaging factory, drug registration agent)
  • Signed contract by the applicant and the institution(s)
  • Signed declaration by the applicant and the drug registration agent
  • Protocol
  • Principal investigator and investigator(s) names
  • List of participating institutions
  • Proposed Investigator Brochure (IB)
  • Informed consent form(s) (ICFs) (See Informed Consent topic, Requirements/Elements subtopic for additional information)

For further guidance on requirements for supplementary application submissions and registration renewals for imported drugs and more, please refer to Additional Resource (C).

EC Requirements
Each EC has its own application form and clearance requirements which can differ significantly regarding the number of copies to be supplied and application format requirements. However, the requirements list provided below is basically consistent across all Chinese ECs.

The following list was compiled from the RegEthics and the EthicsGuide to exemplify the common elements shared by the various application forms:

  • Application for Human Research Ethics Review (See Additional Resource (D))
  • Application Protocol for Results of Research or Related Technologies
  • Protocol
  • Sample ICF (See Informed Consent topic, Children/Minors subtopic for additional information)
  • Case Report Form
  • Principal investigator(s) CV(s)
  • CFDA 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
  • Site list
  • Site profile(s)
  • Product literature
  • Insurance policy (if any)
  • Materials provided to participants

Clinical Protocol
As delineated in the PRC-GCPs, the clinical protocol should include the following elements:

  • 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 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
  • IP registration, usage record, delivery, handling and storage conditions (See Investigational Products topic for detailed coverage of this subject)
  • 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 Clinical Trial Lifecycle topic, Safety Reporting subtopic for additional information)
  • Proposed trial schedule and completion date

For complete protocol requirements, please refer to Article 17 of the PRC-GCPs.

ADDITIONAL RESOURCES

(A) (Guideline) Importing Pharmaceutical Products to China (July 2014)
EU SME Centre, Beijing, China

Relevant Sections: Imported Drugs Need Pre-market Approval Before Entering the Chinese Market; Biological Products Registration; Annexes 2 and 3; and Links to the Chinese Administration Webpages

(B) (Website) Application and Approval Procedure for Clinical Trials (May 24, 2004)
China Food and Drug Administration, State Council of the People's Republic of China, People’s Republic of China

(C) (Website) China Food and Drug Administration – Regulatory Guide - Drugs (Current as of April 30, 2015)
China Food and Drug Administration, State Council of the People's Republic of China, People’s Republic of China

(D) (Form) Application for Human Research Ethics Review (Current as of April 30, 2015)
Independent Ethics Committee, Shanghai Clinical Research Center, Shanghai, People’s Republic of China

(E) (Website) Application and Approval Procedure for Imported Drugs (1) (June 11, 2004)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

(F) (Form) Human Research Ethics Review Application Documents (Current as of April 30, 2015)
Independent Ethics Committee, Shanghai Clinical Research Center, Shanghai, People’s Republic of China

(G) (Website) Shanghai Clinical Research Center – Independent Ethics Committee (Current as of April 30, 2015)
Independent Ethics Committee, Shanghai Clinical Research Center, Shanghai, People’s Republic of China

(H) (Article) China’s State Food and Drug Administration Discusses Drug Applications: A Q &A with Officers of the Departments of State Food and Drug Administration, China, moderated by Ji Xie (November 2, 2010)
Pharmaceutical Technology

Relevant Section: Pages 66-70

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 3 (Article 10), Chapter 4 (Article 17), and Chapter 6 (Article 35)

(2) (Legislation) Provisions for Drug Registration (Order No. 28) (PDR) (Standard Chinese/Zhōngwén) (Effective Date: October 1, 2007)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter II (Articles 11, 12, 18, 19, 24, 25, 26, and 27), Chapter III (Articles 31 and 37), Chapter IV (Section 1), Chapter V (Articles 81 and 82), and Chapter VI (Articles 92, 93, and 94)

(3) (Legislation) Drug Administration Law of the People’s Republic of China (Order No. 45) (DAL) (Effective Date: December 1, 2001)
National People’s Congress, People’s Republic of China

Relevant Section: Chapter V (Article 29)

(4) (Regulation) Regulations for Implementation of the Drug Administration Law of the People’s Republic of China (Decree No. 360) (RegImplemDAL) (Effective Date: September 15, 2002)
State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter V (Articles 29 and 30)

(5) (Guidance) Ethical Review of Biomedical Research Involving Human Subjects (Trial Implementation) (RegEthics – English, unofficial translation) (Standard Chinese/Zhōngwén) (January 11, 2007)
Ministry of Health of the People’s Republic of China, People’s Republic of China

Relevant Section: Chapter 3 (Article 15)

(6) (Guidance) Guiding Principles for the Ethical Review of Clinical Trials of Drugs (EthicsGuide – English, unofficial translation) (Standard Chinese/Zhōngwén) (November 2, 2010)
China Food and Drug Administration, People’s Republic of China

Relevant Sections:
Chapter 2 (Articles 5, 6, 8, 9, 10, and 12), Chapter IV (Articles 18-21), and Chapter V (Article 22)

(7) (Guidance) Approval for Clinical Trials of Imported (incl. from Hong Kong, Macao and Taiwan) Chemicals (G-CTImprtChem) (December 6, 2013)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: VI, VII, VIII, IX, X, and XIII

Clinical Trial Lifecycle > Timeline of Review
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
Based on the PDR and the G-CTImprtChem, the China Food and Drug Administration’s (CFDA) approval of a clinical trial application is dependent upon obtaining proof of the ethics committee’s (EC) approval. Information available on the CFDA and the National Health and Family Planning Commission (NHFPC) of the People’s Republic of China websites do not specify whether the application may be submitted in parallel to the CFDA and the EC for review.

CFDA Approval
According to the PDR, the CFDA’s review and approval process typically takes an average of 145 working days upon receipt of the application. By comparison, the CFDA clinical trial application flowchart in Additional Resource (A) states that the approximate timeframe required for CFDA review and approval is 155 to 195 days.

As indicated by the G-CTImprtChem and Additional Resources (B) and (C), the CFDA review and approval process is usually longer for imported drugs, and typically requires an additional two (2) months due to the additional time required by the Center for Drug Evaluation (CDE) (website in Chinese and English) to conduct its technical review and the National Institutes for Food and Drug Control (NIFDC) to test drug samples and review standards.

As per the PDR, the G-CTImprtChem and Additional Resources (A) and (B), the CFDA timeframe is based on a two-tiered review process. When an applicant submits a clinical trial application to the CFDA’s Administrative Acceptance Service Center, the first review tier is essentially administrative. Within five (5) days of the application’s submission, the CFDA’s Department of Drug Registration (DDR) conducts a preliminary review of the application to confirm the content is properly formatted. Both the PDR and the G-CTImprtChem state that if the CFDA fails to notifiy the applicant of its decision within five (5) days, the application should be deemed as accepted from the date of receipt of this dossier.

As per the PDR and Additional Resources (A) and (B), if the application is accepted, within the next 30 days, the DDR reviews the application for completeness, examines the drug development conditions and raw data, conducts site inspection and sample testing, and sends a notice to the NIFDC or a corresponding drug testing institute based in a province, autonomous region, or municipality) to conduct testing and specifications verification.

By comparison, the G-CTImprtChem states that, following the CFDA Administrative Center’s acceptance of an imported drug application dossier, the Center is required to notify the NIFDC that it must conduct a registration inspection within 30 days from the acceptance date. The NIFDC has 85 days to test samples and review standards. After receiving the dossier information and samples, the NIFDC must arrange with various drug control institutions to conduct registration testing within five (5) days. The drug control institutions must then complete their registration inspections within 60 days from receipt of the dossiers and samples, and submit their reports to the NIFDC. After the NIFDC reviews the registration test reports and imported drug registration standards, a technical review must be carried out by NIFDC experts within 20 days.

The second review tier is a technical evaluation and is conducted by the CFDA’s Center for Drug Evaluation (CDE). For detailed information on the technical evaluation process, refer to the CDEProcs. According to the PDR and the G-CTImprtChem, this review takes 90 days; however, the CFDA flowchart in Additional Resource (A) states that this review generally takes 100-120 days. The NIFDC or corresponding drug testing institute simultaneously conducts sample testing and specifications verification while the CDE is reviewing the application. According to Additional Resources (A) and (B), this process typically takes 60 days for new drugs or generic drugs, and 85 days for imported drugs. Once the institute has verified the drug specification, it submits a Certificate of Analysis to the CDE. As per the PDR, when the CDE evaluation is complete, the CFDA reviews the CDE’s recommendations and makes the final decision to issue the drug license within 20 days for new or generic drugs, and 20-40 days for imported drugs. By comparison, the G-CTImprtChem states that the CFDA’s Administrative Center is responsible for making a licensing decision for the imported drug dossier within 20 days of receiving the CDE’s completed technical review; an extension of 10 days may be issued upon request. The CFDA Administrative Center will deliver its decision to the applicants within 10 days from the date of making its decision.

For further guidance on CFDA timelines for supplementary application submissions and registration renewals for imported drugs and more, please refer to Additional Resource (E).

EC Approval
An applicant must also submit the clinical trial application for review and approval by an institutional EC. In addition, the PRC-GCPs states that the EC should hold a meeting as soon as possible after receiving the application to review and discuss it. 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.

ADDITIONAL RESOURCES

(A) (Website) Application and Approval Procedure for Clinical Trials (May 24, 2004)
China Food and Drug Administration, State Council of the People's Republic of China, People’s Republic of China

(B) (Website) Application and Approval Procedure for Imported Drugs (1) (June 11, 2004)
China Food and Drug Administration,State Council of the People’s Republic of China, People’s Republic of China

(C) (Article) China’s State Food and Drug Administration Discusses Drug Applications: A Q&A with Officers of the Departments of State Food and Drug Administration, China, moderated by Ji Xie (November 2, 2010)
Pharmaceutical Technology

Relevant Section: Pages 66-70

(D) (Article) Overview of Drug Evaluation System in China (March 18, 2010)
Lu, Dong and Huang, Wenlong
Scientific Research and Essays

Relevant Section: Vol. 5(6), Pages 514-518

(E) (Website) China Food and Drug Administration – Regulatory Guide - Drugs (Current as of April 30, 2015)
China Food and Drug Administration, State Council of the People's Republic of China, People’s Republic of China

REQUIREMENTS

(1) (Legislation) Provisions for Drug Registration (Order No. 28) (PDR) (Standard Chinese/Zhōngwén) (Effective Date: October 1, 2007)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter III (Article 37), Chapter IV (Section 1), Chapter V, Chapter VI (Section 1), Chapter XII, Chapter XIII, and Chapter X

(2) (Guidance) Principles and Procedures for Drug Evaluation and Review (CDEProcs) (April 13, 2011)
Center for Drug Evaluation, China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapters I and II

(3) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Section: Chapter 3 (Article 13)

(4) (Guidance) Approval for Clinical Trials of Imported (incl. from Hong Kong, Macao and Taiwan) Chemicals (G-CTImprtChem) (December 6, 2013)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: VI, VIII, IX, X, XI, and XIII

Clinical Trial Lifecycle > Trial Initiation
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
In accordance with the PRC-GCPs, the PDR, the DAL, the RegImplemDAL, the RegEthics, the EthicsGuide, and the G-CTImprtChem, the sponsor must apply to the China Food and Drug Administration (CFDA) and an ethics committee (EC) to conduct a clinical trial for all drugs to be registered in China. As stated in the PDR, the CFDA’s approval of a clinical trial application is dependent upon obtaining proof of the EC’s approval. The PDR and Additional Resource (A) also state that a Chinese legal entity must submit the drug registration application. Clinical trial applications are also considered to be drug registration applications. Overseas drug manufacturers without legal representation in China must apply for product registration through an agent with professional knowledge and familiarity with Chinese laws and regulations.

The investigators must possess the appropriate qualifications, training, and experience to assume responsibility for the trial which must be conducted in compliance with the PRC-GCPs and the PDR.

The PRC-GCPs 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.

Clinical Trial Agreement
As delineated in the PDR, the sponsor must sign an agreement or contract with the participating institution(s). The PRC-GCPs 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.

EC Confirmation of Review and Approval
The PRC-GCPs mandate that the sponsor receive written confirmation of EC review and approval of the protocol prior to the trial’s commencement.
(See Ethics Committee topic, Scope of Review subtopic and Clinical Trial Lifecycle topic, Submission Content subtopic for additional details on the EC review process).

Chinese Clinical Trial Registry (ChiCTR) Recording Requirements
Once the trial has obtained approval from the China Food and Drug Administration (CFDA) and from the EC, the sponsor is responsible for registering the trial with the Chinese Clinical Trial Registry (ChiCTR) before commencing the trial. The ChiCTR website provides complete details on registration procedures.

Data and Safety Monitoring Board
The sponsor is also required to establish a Data Safety Monitoring Board (DSMB) and submit its composition to the EC prior to the trial’s commencement. The DSMB’s duty is to regularly assess the progress of the trial, analyze safety data, and monitor the trial. For additional details on DSMB requirements, see the EthicsGuide.

ADDITIONAL RESOURCES

(A) (Guideline) Importing Pharmaceutical Products to China (July 2014)
EU SME Centre, Beijing, China

Relevant Sections: Imported Drugs Need Pre-market Approval Before Entering the Chinese Market; Biological Products Registration; Annexes 2 and 3; and Links to the Chinese Administration Webpages

(B) (Article) China and India Join WHO’s Trial Registry Platform (July 25, 2007)
Mansell, Peter
PharmaTimes Online

(C) (Website) Chinese Clinical Trial Registry (ChiCTR)Registration (Standard Chinese/Zhōngwén) (Current as of April 30, 2015)
Chinese Clinical Trial Register, Sichuan, China

(D) (Website) Chinese Clinical Trial Registry (ChiCTR)Frequently Asked Questions (Current as of April 30, 2015)
Chinese Clinical Trial Register, Sichuan, China

REQUIREMENTS

(1) (Legislation) Provisions for Drug Registration (Order No. 28) (PDR) (Standard Chinese/Zhōngwén) (Effective Date: October 1, 2007)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter I (Article 5), Chapter II (Article 24), and Chapter III (Articles 30, 34, 35, 36, and 37)

(2) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 2 (Articles 6 and 7), Chapter 3 (Article 10), Chapter 4 (Article 17), and Chapter 6 (Articles 35 and 43)

(3) (Guidance) Good Manufacturing Practice for Drugs (2010 Revision) – (MOH Decree No. 79) (PRC-GMPs) (Effective as of March 1, 2011)
Ministry of Health of the People’s Republic of China, People’s Republic of China

(4) (Guidance) Guiding Principles for the Ethical Review of Clinical Trials of Drugs (EthicsGuide – English, unofficial translation) (Standard Chinese/Zhōngwén) (November 2, 2010)
China Food and Drug Administration, People’s Republic of China

Relevant Section: Glossary of Terms, Chapter 3 (Article 15) and Chapter 4

(5) (Guidance) Approval for Clinical Trials of Imported (incl. from Hong Kong, Macao and Taiwan) Chemicals (G-CTImprtChem) (December 6, 2013)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: VI, VII, VIII, IX, X, and XIII

(6) (Legislation) Drug Administration Law of the People’s Republic of China (Order No. 45) (DAL) (Effective Date: December 1, 2001)
National People’s Congress, People’s Republic of China

Relevant Section: Chapter V (Article 29)

(7) (Regulation) Regulations for Implementation of the Drug Administration Law of the People’s Republic of China (Decree No. 360) (RegImplemDAL) (Effective Date: September 15, 2002)
State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter V (Articles 29 and 30)

Clinical Trial Lifecycle > Safety Reporting
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
In accordance with the PRC-GCPs and the ADRGuide, the following definitions provide a basis for a common understanding of China’s safety reporting requirements:

  • Adverse Event (AE) – An untoward medical event in a patient or clinical investigation participant who is administered a drug, and which does not necessarily have a causal relationship with the treatment
  • Serious Adverse Event (SAE) – Any untoward medical occurrence resulting in death, disability/incapacity, effect on work capability, congenital anomaly , is life threatening, requires in-patient hospitalization, or prolongation of hospitalization that occurs during a clinical trial
  • Adverse Drug Reaction (ADR) – A harmful reaction that occurs irrespective of the intended use or unexpectedly when a qualified drug is used in its normal dose and administration method
  • Serious Adverse Drug Reaction (SADR) –  A drug reaction that results in death; cancer, deformity or birth defect; permanent or distinctive impairment and physical disabilities; permanent organ damage, hospitalization or prolonged hospitalization; or is life-threatening

Reporting Requirements for AE/ADRs
As delineated in the PRC-GCPs and the PDR, the investigator is responsible for reporting all AEs/ADRs and SAEs/SADRs to the sponsor. The investigator and his/her institution must immediately report all expected and unexpected SAEs to the sponsor, the provincial, autonomous regional, or municipal drug authority and to the China Food and Drug Administration (CFDA), and the ethics committee (EC) within 24 hours of occurrence. The sponsor and the investigator are also required to study the SAEs immediately after the occurrence and take necessary measure to ensure participant safety and welfare. Other investigators conducting clinical trials on the same drug must also be contacted.

Data and Safety Monitoring Board
The sponsor is also required to establish a Data Safety Monitoring Board (DSMB) to regularly assess the progress of the trial, analyze safety data, and monitor the pilot program. For additional details on DSMB requirements, see the EthicsGuide.

ADDITIONAL RESOURCES

(A) (Website) Center for Drug Reevaluation, SFDA – National Center for ADR Monitoring, China (Current as of October 17, 2016)
China Food and Drug Administration, People’s Republic of China

(B) (Article) Drug Safety Surveillance in China and Other Countries: A Review and Comparison (2008)
Du, Wenmin; Guo, Jeff; Jing, Yonghua; Li, Xing; Kelton, Christina M.L.
Value in Health

Relevant Section: Volume 11, Supplement 1, pages S130-S136

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 1 (Articles 6 and 10), Chapter 3 (Article 10), Chapter 4 (Article 7), Chapter 5 (Articles 25 and 26), and Chapter 6 (Articles 36, 39, and 40)

(2) (Guidance) Provisions for Reporting and Monitoring of Adverse Drug Reactions (ADRGuide – English, unofficial translation) (Current as June 21, 2013)
China Food and Drug Administration, People’s Republic of China

Relevant Section: Chapter 6 (Article 29)

(3) (Legislation) Provisions for Drug Registration (Order No. 28) (PDR) (Standard Chinese/Zhōngwén) (Effective Date: October 1, 2007)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Section: Chapter III (Article 41)

(4) (Guidance) Guiding Principles for the Ethical Review of Clinical Trials of Drugs (EthicsGuide – English, unofficial translation) (Standard Chinese/Zhōngwén) (November 2, 2010)
China Food and Drug Administration, People’s Republic of China

Relevant Section: Glossary of Terms

Clinical Trial Lifecycle > Progress Reporting
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
Relevant provisions are only available regarding the final report.

In accordance with the PRC-GCPs and the PDR, the investigator is responsible for preparing the final report following the conclusion of a clinical trial and then forwarding the report to the sponsor. The sponsor, in turn, must submit the report to the China Food and Drug Administration (CFDA).

As per the PRC-GCPs, the final report must conform to the protocol and contain the following elements:

  • Actual number of participants/cases that randomly participated in each treatment group; participant dropouts, and those released from the trial accompanied by the reason for each
  • Comparison of baseline characteristics among different treatment groups
  • Statistical and clinical analysis for all of the indexes of the therapeutic effects evaluation
  • Safety evaluation containing a statistical analysis of adverse events with a detailed description of each, and laboratory indexes included
  • Assessment of the therapeutic effects in a multicenter trial, and the effects among each center
  • Summary of the relationship between the therapeutic effects and safety as well as risks and benefits associated with the investigational products
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 5 (Article 30), Chapter 6 (Article 42), and Chapter 8 (Article 51)

(2) (Legislation) Provisions for Drug Registration (Order No. 28) (PDR) (Standard Chinese/Zhōngwén) (Effective Date: October 1, 2007)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Section: Chapter III (Article 39)

Sponsorship > Definition of Sponsor
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
As per the Definitions section of the PRC-GCPs, a sponsor is defined as a company, institution, or organization who initiates a clinical trial and is responsible for managing, financing, and monitoring the trial.

A sponsor can authorize his/her designated contract research organization (CRO) to carry out certain work and obligations regarding the clinical trial. A sponsor may also be domestic or foreign.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 6 (Article 32) and Chapter 10 (Article 38)

Sponsorship > Trial Authorization
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
In accordance with the PRC-GCPs and the G-CTImprtChem, the sponsor or his/her designated contract research organization (CRO) is responsible for submitting a clinical trial application to the China Food and Drug Administration (CFDA) to obtain approval to conduct a study.

To complete the clinical trial application package, the sponsor or the CRO must use the CFDA’s clinical trial application form as discussed in the PDR, the G-CTImprtChem, and Additional Resource (A). In addition to the completed application, the sponsor or the CRO must also provide the following:

  • Clinical protocol
  • Ethics committee approval letter
  • Informed consent form template
  • Signed agreement/contract between the sponsor and the institution(s)
  • Signed declaration by the applicant and the drug registration agent
  • List of participating institutions
  • Principal investigator and investigator(s) names

The PDR and Additional Resource (B) also state that a Chinese legal entity must submit the drug registration application. Clinical trial applications are also considered to be drug registration applications. Overseas drug manufacturers without legal representation in China must apply for product registration through an agent with professional knowledge and familiarity with Chinese laws and regulations.

Additional documentation that must be submitted is covered in the Clinical Trial Lifecycle topic, Submission Content subtopic.

ADDITIONAL RESOURCES

(A) (Article) China’s State Food and Drug Administration Discusses Drug Applications: A Q &A with Officers of the Departments of State Food and Drug Administration, China, moderated by Ji Xie (November 2, 2010)
Pharmaceutical Technology

Relevant Section: Pages 66-70

(B) (Guideline) Importing Pharmaceutical Products to China (July 2014)
EU SME Centre, Beijing, China

Relevant Sections: Imported Drugs Need Pre-market Approval Before Entering the Chinese Market; Biological Products Registration; Annexes 2 and 3; and Links to the Chinese Administration Webpages

(C) (Article) China and India Join WHO’s Trial Registry Platform (July 25, 2007)
Mansell, Peter
PharmaTimes Online

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Section: Chapter 6 (Article 32)

(2) (Legislation) Provisions for Drug Registration (Order No. 28) (PDR) (Standard Chinese/Zhōngwén) (Effective Date: October 1, 2007)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter II (Articles 11, 12, 18, 19, and 24) and Chapter III (Article 37)

(3) (Guidance) Approval for Clinical Trials of Imported (incl. from Hong Kong, Macao and Taiwan) Chemicals (G-CTImprtChem) (December 6, 2013)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: VI, VII, VIII, IX, X and XIII

Sponsorship > Insurance
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
As set forth in the PRC-GCPs, the sponsor is responsible for providing insurance coverage for any unforeseen injury to research participants.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Section: Chapter 6 (Article 43)

Sponsorship > Compensation
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
In accordance with the PRC-GCPs, the sponsor is responsible for providing compensation to research participants and/or their legal heirs in the event of trial-related injuries or death. The sponsor must also ensure that participants who suffer any trial-related injuries are provided with free medical treatment for such injuries. (See Informed Consent topic, Compensation Disclosure subtopic for more information on participant compensation rights).

ADDITIONAL RESOURCES

(A) (Article) China – Compensation for Drug and Device-Related Injuries (December 2008)
Gourley, Sara; Chen, Yang; and Bass, Scott
PLC Cross-Border Life Sciences Handbook 2008/09

Relevant Section: Pages 1-4

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 6 (Article 43) and Appendix 2

(2) (Guidance) Provisions for Reporting and Monitoring of Adverse Drug Reactions (ADRGuide – English, unofficial translation) (Current as of June 21, 2013)
China Food and Drug Administration, People’s Republic of China

Relevant Section: Article 29

Sponsorship > Quality, Data & Records Management
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
As stated in the PRC-GCPs, the sponsor must establish quality control (QC) and quality assurance (QA) systems for the clinical trial. He/she may also choose to organize an audit group to provide additional QA/QC oversight. In addition, the sponsor and the investigator are required to prepare standard operating procedures (SOPs) outlining their respective responsibilities to ensure that the trial is conducted in compliance with the protocol and the PRC-GCPs. A written agreement must be signed by both the sponsor and the investigator verifying that both parties agree to the trial protocol, the monitoring and auditing practices, the SOPs, and their respective duties.

The sponsor must also submit the protocol to the ethics committee (EC) for approval prior to implementation.

Record Management
As set forth in the PRC-GCPs, all clinical trial data must be stored and managed in accordance with Appendix 2. The sponsor should inform the investigator(s) that trial documentation must be retained for five years following the trial’s completion. In addition, the sponsor must appoint a qualified monitor, who must also be approved by the investigator. The sponsor should also retain all trial-related documents and materials for five years after the investigational product has been approved for marketing.

Audit Requirements
As per the PRC-GCPs, the sponsor; the China Food and Drug Administration (CFDA); and provincial, autonomous region, or municipal drug authorities should authorize an auditor to carry out systematic checks on clinical trial operations and the document filing system to ensure the trial is being conducted in compliance with the protocol, the SOPs, and relevant regulations. The auditor must also verify that the data record system is accurate, timely, and complete. The audit must be conducted by personnel not directly involved in the clinical trial.

Premature Study Termination/Suspension
The PRC-GCPs state that if the sponsor chooses, or is required to terminate a study, he/she must immediately inform the investigator(s), institution(s), the EC, and the CFDA, and explain the reason.

Multicenter Studies
In the event of a multicenter clinical trial, the sponsor and the principal investigators of each center must jointly discuss the protocol, and obtain EC approval prior to implementation. According to the G-CTImprtChem, for multicenter trials, documentation demonstrating that the clinical trial imported drugs have been prepared according to good manufacturing practices (GMPs) should be included in the application dossier.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 2 (Article 7), Chapter 4 (Article 16), Chapter 6 (Articles 32, 33, 38, 39, and 41), Chapter 11 (Articles 52, 53, 61, and 63), Chapter 12 (Article 66), and Appendix 2

(2) (Guidance) Good Manufacturing Practice for Drugs (2010 Revision) – (MOH Decree No. 79) (PRC-GMPs) (Effective as of March 1, 2011)
Ministry of Health of the People’s Republic of China, People’s Republic of China

(3) (Guidance) Approval for Clinical Trials of Imported (incl. from Hong Kong, Macao and Taiwan) Chemicals (G-CTImprtChem) (December 6, 2013)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Section: VII

Sponsorship > Site/Investigator Selection
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
As set forth in the PRC-GCPs, 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. 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). (See the Clinical Trial Lifecycle topic, Submission Content subtopic for additional information on clinical trial application requirements).

As per the EthicsGuide, the sponsor is also required to establish a Data Safety Monitoring Board (DSMB) prior to a trial’s commencement, and submit its composition to the EC. The DSMB’s duty is to regularly assess the progress of the trials, analyze safety data, and monitor the trial.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 2 (Article 6) and Chapter 6 (Articles 33 and 34)

(2) (Guidance) Guiding Principles for the Ethical Review of Clinical Trials of Drugs (EthicsGuide – English, unofficial translation) (Standard Chinese/Zhōngwén) (November 2, 2010)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 3 (Article 15) and Chapter 4

Informed Consent > Documentation Requirements
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
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 PRC-GCPs, the RegEthics, and the EthicsGuide.

As per the PRC-GCPs, the PDR, and the EthicsGuide, 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 China Food and Drug Administration (CFDA) with the clinical trial application. (See the Informed Consent topic, Required Elements subtopic for details on what should be included in the form.)

The PRC-GCPs states that the investigator, or a person designated by the investigator, must provide detailed research study information to the participant and/or his/her legal representative(s) or guardian(s). As delineated in the PRC-GCPs, the RegEthics, and the EthicsGuide, 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 his/her legal representative(s) or guardian(s) should also be given adequate time to consider whether to participate.

Language Requirements
Additional Resources (A) and (B) state that all clinical trial applications and supporting materials, including the ICF, must be in Chinese. The PRC-GCPs, the RegEthics, and the EthicsGuide require the ICF to be presented in oral or written form in a simple language that the participant is able to understand.

Documentation Copies
As per the PRC-GCPs, the participant and/or his/her legal representative(s) or guardian(s) as well as the investigator must sign and date the ICF. A copy of the signed ICF should be retained by the investigator, and one copy should be sent to the sponsor.

ADDITIONAL RESOURCES

(A) (Article) China’s State Food and Drug Administration Discusses Drug Applications: A Q &A with Officers of the Departments of State Food and Drug Administration, China, moderated by Ji Xie (November 2, 2010)
Pharmaceutical Technology

Relevant Section: Pages 66-70

(B) (Presentation) Overview of Clinical Trial Regulations in India, China, and Russia (June 21, 2009)
Mehra, Munish and Vakharia, Shehnaz K.
Drug Information Association 45th Annual Meeting

Relevant Section: Pages 30-46

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 3 (Articles 8, 12, 14, and 15), Chapter 4 (Article 15), Chapter 5 (Article 24), and Chapter 13 (Article 68)

(2) (Guidance) Ethical Review of Biomedical Research Involving Human Subjects (Trial Implementation) (RegEthics – English, unofficial version) (Standard Chinese/Zhōngwén) (January 11, 2007)
Ministry of Health of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter 3 (Articles 16 and 17)

(3) (Guidance) Guiding Principles for the Ethical Review of Clinical Trials of Drugs (EthicsGuide – English, unofficial translation) (Standard Chinese/Zhōngwén) (November 2, 2010)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter V (Articles 28 and 30) and Appendix 1 (Section 5)

(4) (Legislation) Provisions for Drug Registration (Order No. 28) (PDR) (Standard Chinese/Zhōngwén) (Effective Date: October 1, 2007)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Section: Chapter III (Article 37)

Informed Consent > Required Elements
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
As delineated in the PRC-GCPs and the EthicsGuide, prior to beginning a clinical trial, the investigator is required to obtain ethics committee (EC) approval for the written informed consent form (ICF), and any other information being provided to the research participant and/or his/her legal representative(s) or guardian(s).

The PRC-GCPs, the EthicsGuide, and the RegEthics state that information should be presented in easily understandable language, and may be presented in written and/or oral form. Adequate time should be given to the participant and/or his/her legal representative(s) or guardian(s) to inquire about the details of the study and have all questions answered to his/her satisfaction.

ICF Required Elements
Based on the PRC-GCPs and the EthicsGuide, the ICF should include the following statements or descriptions, as applicable:

  • The study purpose, the 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
  • Treatment available to participants as well as important potential risks and benefits associated with this treatment
  • 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 EC, the China Food and Drug Administration (CFDA), and drug authorities in the provinces, autonomous regions, and municipalities may be required to review participant data
  • Any treatment and corresponding compensation participants can expect to receive in the event of a trial-related injury
  • 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
  • Contact information for the sponsor and investigator in the event of participant problems or injuries related to the trial

See the Informed Consent topic, Compensation Disclosure subtopic and Vulnerable Populations subtopic for additional information.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 3 (Article 12), Chapter 4 (Article 15), and Chapter 5 (Article 24)

(2) (Guidance) Guiding Principles for the Ethical Review of Clinical Trials of Drugs (EthicsGuide – English, unofficial translation) (Standard Chinese/Zhōngwén) (November 2, 2010)
China Food and Drug Administration, People’s Republic of China

Relevant Sections:
Chapter 5 (Articles 28 and 30) and Appendix 1 (Sections 4 and 5)

(3) (Guidance) Ethical Review of Biomedical Research Involving Human Subjects (Trial Implementation) (RegEthics – English, unofficial version) (Standard Chinese/Zhōngwén) (January 11, 2007)
Ministry of Health of the People’s Republic of China, People’s Republic of China

Relevant Section: Chapter 3 (Article 17)

Informed Consent > Compensation Disclosure
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
In accordance with the PRC-GCPs and the EthicsGuide, the informed consent form (ICF) should contain a statement describing the compensation or medical treatment a participant can receive for participating in a clinical trial.

Compensation for Participation in Research
As stated in the EthicsGuide, the ICF should contain a statement with a description of the nature, form, and extent of compensation for study participation. The ICF should also inform the participants if they will need to pay for any expenses in order to participate in the trial.

Compensation for Injury
As per the PRC-GCPs and the EthicsGuide, the ICF should include a statement advising the participant that compensation and medical treatment is available in the event of any trial-related injury. (See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF.)

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Section: Chapter 3 (Article 14)

(2) (Guidance) Guiding Principles for the Ethical Review of Clinical Trials of Drugs (EthicsGuide – English, unofficial translation) (Standard Chinese/Zhōngwén) (November 2, 2010)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter V (Articles 28 and 30) and Appendix 1 (Section 5)

Informed Consent > Participant Rights
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
In accordance with the Declaration of Helsinki principles set forth in the PRC-GCPs and the RegEthics, China’s ethical 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). As indicated in the PRC-GCPs and the EthicsGuide, a participant’s rights must be clearly addressed in the informed consent form (ICF) and during the informed consent process. (See the Informed Consent topic, and the subtopics of Required Elements; Vulnerable Populations; Children/Minors; Pregnant Women, Fetuses & Neonates; Prisoners; and Mentally Impaired for additional information regarding requirements for participant rights.)

The Right to Participate, Abstain, or Withdraw
As set forth in the PRC-GCPs and the EthicsGuide, the participant or his/her legal representative(s) or guardian(s) should be informed that participation is voluntary, that he/she 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 EthicsGuide and the PRC-GCPs, a potential research participant and/or his/her legal representative(s) or guardian(s) 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 Informed Consent topic, Required Elements subtopic for more detailed information regarding participant rights.)

The Right to Privacy and Confidentiality
As per the EthicsGuide, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right. The PRC-GCPs also state 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 EthicsGuide states that the research participant and/or his/her legal representative(s) or guardian(s) 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 his/her rights. (See the Informed Consent topic, Required Elements subtopic for more detailed information regarding participant rights.)

The Right to Safety and Welfare
The PRC-GCPs clearly states that a research participant’s right to safety and the protection of his/her health and welfare must take precedence over the interests of science and society.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Section: Chapter 1 (Article 4), Chapter 3 (Articles 8 and 14), Appendix 1 (Sections B and C)

(2) (Guidance) Ethical Review of Biomedical Research Involving Human Subjects (Trial Implementation) (RegEthics – English, unofficial version) (Standard Chinese/Zhōngwén) (January 11, 2007)
Ministry of Health of the People’s Republic of China, People’s Republic of China

Relevant Section: Chapter 1 (Article 1)

(3) (Guidance) Guiding Principles for the Ethical Review of Clinical Trials of Drugs (EthicsGuide – English, unofficial translation) (Standard Chinese/Zhōngwén) (November 2, 2010)
China Food and Drug Administration, People’s Republic of China

Relevant Section: Appendix 1 (Section 4)

Informed Consent > Special Circumstances/Emergencies
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
The PRC-GCPs make provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by special circumstances. Special circumstances can be medical emergencies, or when a participant is mentally incapacitated.

Medical Emergencies
As per the PRC-GCPs, in an emergency, if the signed informed consent form (ICF) has not been obtained from the research participant or his/her legal representative(s) or guardian(s), 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 file, and the ethics committee (EC) must approve the protocol in advance. Moreover, the PRC-GCPs states that the investigator is required to conduct the trial in a medical institution with good medical treatment facilities, laboratory equipment, and personnel. The institution must have all the necessary resources to handle emergency situations to ensure participant safety.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 3 (Articles 12, 14, and 15) and Chapter 5 (Article 22)

Informed Consent > Vulnerable Populations
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
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 EthicsGuide defines 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.

The PRC-GCPs, which upholds the principles of the Declaration of Helsinki 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. This population is characterized by those who are economically and medically disadvantaged, and those who have lost or lack the capability to protect their own rights including children, pregnant women, mentally impaired persons, and prisoners.

As per the EthicsGuide, trials involving vulnerable persons must meet the following requirements:

  • The trial can only be performed well if the vulnerable persons act as research participants
  • The trial targets specific diseases or health problems of the vulnerable population
  • When the trial cannot directly provide the possibility of benefiting vulnerable persons, the risk of the trial should not exceed a minimal risk, unless the ethics committee (EC) agrees to slightly increase the extent of the risk
  • When a participant cannot provide complete informed consent, his/her legal representative(s) or guardian(s) must provide consent

For additional information, see the Informed Consent topic and the subtopics of Children/Minors and Mentally Impaired.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Section: Appendix 1 (Section A)

(2) (Guidance) Guiding Principles for the Ethical Review of Clinical Trials of Drugs (EthicsGuide – English, unofficial translation) (Standard Chinese/Zhōngwén) (November 2, 2010)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Appendix 1 (Section 8) and Glossary

(3) (Guidance) Ethical Review of Biomedical Research Involving Human Subjects (Trial Implementation) (RegEthics – English, unofficial version) (Standard Chinese/Zhōngwén) (January 11, 2007)
Ministry of Health of the People’s Republic of China, People’s Republic of China

Relevant Section: Chapter 3 (Article 14)

Informed Consent > Children/Minors
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
The applicable regulatory requirements do not specify the age of minors.

In accordance with the PRC-GCPs, when the research participant is a child, the informed consent form (ICF) must be signed by the child’s legal representative(s) or guardian(s). If the child can decide whether he/she is willing 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.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Section: Chapter 3 (Article 15) and Appendix 1 (Section B)

Informed Consent > Pregnant Women, Fetuses & Neonates
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Informed Consent > Prisoners
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Informed Consent > Mentally Impaired
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
The PRC-GCPs allow the ethics committee (EC) to approve the participation of research participants who are incompetent, or mentally or physically incapable of giving consent, if the investigator believes the trial will be beneficial for the participant. The informed consent form (ICF) must be signed and dated by the participant’s legal representative(s) or guardian(s).

Furthermore, in accordance with the Declaration of Helsinki, the PRC-GCPs state that this vulnerable population should not be included in research studies unless the research is necessary to promote the health of the population represented, and the research cannot instead be performed on legally competent participants.

Research to be conducted on participants from whom it is not possible to obtain consent, including proxy or advance consent, should be done only if the physical or mental condition that prevents obtaining informed consent is a necessary characteristic of the research population. The reasons for involving these participants should be delineated in the protocol for the EC’s consideration and approval. The protocol should also state that consent to remain in the research must be obtained as soon as possible from the legal representative(s) or guardian(s).

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Section: Chapter 3 (Article 15) and Appendix 1 (Section B)

Investigational Products > Definition of Investigational Product
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
As delineated in the PRC-GCPs, an investigational product is defined as a study drug, comparator, or placebo used in a clinical trial.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Section: Chapter 13 (Article 68)

Investigational Products > Manufacturing & Import
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
According to the PRC-GCPs, the PDR, the DAL, the RegImplemDAL, and the G-CTImprtChem, the China Food and Drug Administration (CFDA) is responsible for authorizing the manufacture of investigational products (IPs) in China. The CFDA will only approve the manufacture of an IP after the clinical trial application has been approved.

The CFDA is also responsible for authorizing the import of IPs. The PDR, the DAL, and the RegImplemDAL, state that prior to IP import or manufacture, a CFDA import drug license must be obtained for each IP. The G-CTImprtChem also provides detailed CFDA application dossier requirements and instructions to register an imported drug.

In addition, the drug testing institute (the National Institutes for Food and Drug Control (NIFDC) or a corresponding institute on the provincial, autonomous regional, or municipal level) must conduct sample testing and specifications verification of the IP in order to issue a Certificate of Analysis as part of the CFDA’s approval requirements for all registered drugs. (See Clinical Trial Lifecycle topic, Submission Process and Submission Content subtopics for detailed application requirements).

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 1 (Article 1), Chapter 2 (Article 6) and Chapter 6 (Article 35)

(2) (Legislation) Provisions for Drug Registration (Order No. 28) (PDR) (Standard Chinese/Zhōngwén) (Effective Date: October 1, 2007)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter I (Articles 1, 2, 3 and 5), Chapter II (Articles 16, 17, 19, 25 and 29), Chapter IV (Section 2, (Articles 62, 63 and 65)), and (Section 3, (Articles 66, 70 and 72)) and Chapter VI (Section I)

(3) (Legislation) Drug Administration Law of the People’s Republic of China (Order No. 45) (DAL) (Effective Date: December 1, 2001)
National People’s Congress, People’s Republic of China

Relevant Sections: Chapter I (Articles 5 and 6), Chapter II (7, 9, 10 and 13) and Chapter V (Articles 73, 75, 77, 78 and 81), and Chapter VI (Section 1 (Articles 84 and 86)

(4) (Regulation) Regulations for Implementation of the Drug Administration Law of the People’s Republic of China (Decree No. 360) (RegImplemDAL) (Effective Date: September 15, 2002)
State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter II and Chapter V (Articles 29, 30, 36, 38 and 42)

(5) (Guidance) Approval for Clinical Trials of Imported (incl. from Hong Kong, Macao and Taiwan) Chemicals (G-CTImprtChem) (December 6, 2013)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: II, III, VI, VII, VIII, IX, X, XI, and XIII

Investigational Products > IMP/IND Quality Requirements
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
In accordance with the PRC-GCPs and the G-CTImprtChem, the sponsor is responsible for providing the investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) including chemical, pharmaceutical, toxicological, pharmacological, and clinical information and data on the IP, including trials already completed or being conducted in other places.

IB Content Requirements
As per the PRC-GCPs and the G-CTImprtChem, the IP pre-clinical study documents to be supplied by the sponsor must include formulation, manufacturing process, and quality inspection results of the IP. The information should conform to the requirements of the respective corresponding phases of the clinical trial.

In addition, the PRC-GCPs states that the sponsor must also supply the investigator(s) with the IP, reference product, comparator, or placebo. As per  the PRC-GCPs and the G-CTImprtChem, the sponsor should also ensure that the products are manufactured in accordance with Good Manufacturing Practices (GMP) as laid down in the PRC-GMPs. (See Investigational Products topic, Product Management subtopic for additional information on IP supply, storage and handling requirements).

Certificate of Analysis and Drug Manufacturing Certificate Requirements
In accordance with the PDR, the DAL, and the RegImplemDAL, the China Food and Drug Administration (CFDA) requires a Certificate of Analysis (CoA) to be issued by the drug testing institute (the National Institutes for Food and Drug Control (NIFDC) or a corresponding institute on the provincial, autonomous region, or municipal level) once sample testing and specifications verification have been completed for the IP. The CoA must be submitted to the Center for Drug Evaluation (CDE) as part of the CFDA review and approval process. (See Clinical Trial Lifecycle topic, Submission Process and Submission Content subtopics for detailed application requirements).

In addition, as per the PDR, the DAL, the RegImplemDAL, and the G-CTImprtChem, drug manufacturers are required to obtain a Drug Manufacturing Certificate from the CFDA and comply with applicable GMP requirements as laid down in the PRC-GMPs in order to manufacture all IPs.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 2 (Article 6) and Chapter 6 (Articles 34 and 37)

(2) (Guidance) Approval for Clinical Trials of Imported (incl. from Hong Kong, Macao and Taiwan) Chemicals (G-CTImprtChem) (December 6, 2013)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: VI and VII

(3) (Guidance) Good Manufacturing Practice for Drugs (2010 Revision) – (MOH Decree No. 79) (PRC-GMPs) Effective as of March 1, 2011)
Ministry of Health of the People’s Republic of China, People’s Republic of China

(4) (Legislation) Provisions for Drug Registration (Order No. 28) (PDR) (Standard Chinese/Zhōngwén) (Effective Date: October 1, 2007)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter II (Article 19), Chapter IV (Section 2 (Article 65)), and Chapter VI (Section I)

(5) (Legislation) Drug Administration Law of the People’s Republic of China (Order No. 45) (DAL) (Effective Date: December 1, 2001)
National People’s Congress, People’s Republic of China

Relevant Sections: Chapter II (Articles 7, 8, and 9) and Chapter V (Article 39)

(6) (Regulation) Regulations for Implementation of the Drug Administration Law of the People’s Republic of China (Decree No. 360) (RegImplemDAL) (Effective Date: September 15, 2002)
State Council of the People’s Republic of China, People’s Republic of China

Relevant Section: Chapter II ( Articles 3, 4, and 8) and Chapter V (Article 36)

Investigational Products > Labeling & Packaging
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
Investigational product (IP) labeling in China must comply with the requirements set forth in the PRC-GCPs, the ProvLabel, the PDR, the DAL, and the RegImplemDAL. The name, insert sheet, and label of any drug for which registration is applied must comply with the China Food and Drug Administration (CFDA)’s requirements as mandated in the preceding regulations.

As per the PRC-GCPs, the sponsor is responsible for ensuring the proper packaging and labeling of the IPs. The IPs, comparator, and placebo products must be labeled in conformity with the clinical protocol, and be easily recognizable, correctly coded, and marked with special labels indicating that the product is to be used for clinical trial purposes.

The ProvLabel and the DAL state that the following labeling information should be included on the outer packaging and immediate container of all drugs to be registered in China:

  • Adopted name in China
  • Indications or functions
  • Strength, dosage, and usage
  • Production date and batch number
  • Expiration (Should be marked as one day or one month earlier than the actual expiration date, depending on whether the date is labeled to a specific day or month)
  • Manufacturer
  • Ingredients
  • Adverse reactions
  • Contraindications and precautions
  • Storage information
  • Approval number

The label language must also be scientific, standardized, and accurate, and written in standardized Chinese characters published by the National Language Commission.

See ProvLabel and the DAL for detailed labeling instructions.

(See Investigational Product topic, Product Management subtopic for additional information on IP labeling requirements).

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 6 (Article 37) and Chapter 10 (Article 57)

(2) (Guidance) Provisions for Drug Insert Sheets and Labels (SFDA Decree No.24) (ProvLabel) (Effective June 1, 2006)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapters I and III

(3) (Legislation) Provisions for Drug Registration (Order No. 28) (PDR) (Standard Chinese/Zhōngwén) (Effective Date: October 1, 2007)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter XI (Section 3)

(4) (Legislation) Drug Administration Law of the People’s Republic of China (Order No. 45) (DAL) (Effective Date: December 1, 2001)
National People’s Congress, People’s Republic of China

Relevant Section: Chapter VI

(5) (Regulation) Regulations for Implementation of the Drug Administration Law of the People’s Republic of China (Decree No. 360) (RegImplemDAL) (Effective Date: September 15, 2002)
State Council of the People’s Republic of China, People’s Republic of China

Relevant Section: Chapter VI

Investigational Products > Product Management
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
In accordance with the PRC-GCPs and the G-CTImprtChem, the sponsor is responsible for providing the investigators with an Investigator’s Brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs) including chemical, pharmaceutical, toxicological, pharmacological, and clinical information and data on the IP, including trials already completed or being conducted in other places. The IP pre-clinical study documents to be supplied by the investigator must also include formulation, manufacturing process, and quality inspection results of the IP. The information should conform to the requirements of the respective corresponding phases of the clinical trial.

Investigational Product Supply, Storage, and Handling Requirements
As defined in the PRC-GCPs, the sponsor must also supply the investigator(s) with the IP, reference product, and the comparator or placebo.

The sponsor must ensure the following:

  • IP product quality
  • IP manufactured according to good manufacturing practices (GMPs) as per the PRC-GMPs
  • Proper packaging and labeling of the IP in accordance with the protocol, and special marking to indicate that the drug is specifically to be used in a clinical trial
  • IP use record which includes information on the quantity, loading, shipment, receipt, dispensing and handling, and the reclamation and destruction of the unused drug
  • Establishment of management and filing systems for the IPs

Refer to the PRC-GCPs for detailed sponsor-related IP requirements.

Record Requirements
The sponsor is required to keep the clinical trial data for five years after the IP has been approved for marketing. In addition, all of the trial data must be stored and managed as delineated in Appendix 2 of the PRC-GCPs.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Guidance) China Good Clinical Practice (PRC-GCPs – English, unofficial translation) (Standard Chinese/Zhōngwén) (Effective date: September 1, 2003)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter 2 (Article 7), Chapter 3 (Article 10), Chapter 4 (Article 17), Chapter 6 (Articles 35 and 43), Chapter 8 (Article 52), and Appendix 2

(2) (Guidance) Good Manufacturing Practice for Drugs (2010 Revision) – (MOH Decree No. 79) (PRC-GMPs) (Effective as of March 1, 2011)
Ministry of Health of the People’s Republic of China, People’s Republic of China

(3) (Guidance) Approval for Clinical Trials of Imported (incl. from Hong Kong, Macao and Taiwan) Chemicals (G-CTImprtChem) (December 6, 2013)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Section: VI

Specimens > Definition of Specimen
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
The term “specimen” is not referenced within China. As per the DAL, biological products are included in China’s definition of drug products. The DAL specifically states that drug products include Chinese crude drugs, prepared slices of Chinese crude drugs, traditional Chinese medicine preparations, chemical drug substances and their preparations, antibiotics, biochemical drugs, radioactive pharmaceuticals, serums, vaccines, blood products, and diagnostic agents. These products are defined as articles used to prevent, treat, and diagnose human diseases and are intended to regulate physiological functions of human beings, for which indications, usage and dosage are established.

The BiolProdRegs also states that “biological products” refer to vaccine products, blood products, in vitro diagnostic reagents for blood donor screening, and other biological products.

Additional Resource (A) further explains that biological products include both therapeutic and preventive biological products. Therapeutic biological products include monoclonal antibodies; gene therapy, and somatic cell therapy as well as the preparations; allergen products; recombinant DNA technology products; blood products; in vitro diagnostic testing products; and preventive biological products including vaccines.

In addition, the AdminHumanGen defines human genetic resources as genetic materials such as human organs; tissues; cells; blood specimens; or preparations of any type of recombinant DNA constructs, which contain human genome, genes, or gene products. This term also refers to any information related to the previously listed genetic materials.

ADDITIONAL RESOURCES

(A) (Guideline) Importing Pharmaceutical Products to China (July 2014)
EU SME Centre, Beijing, China

Relevant Section: Biological Products Registration

REQUIREMENTS

(1) (Legislation) Drug Administration Law of the People’s Republic of China (Order No. 45) (DAL) (Effective Date: December 1, 2001)
National People’s Congress, People’s Republic of China

Relevant Section: Chapter X (Article 102)

(2) (Regulation) Provisions for Lot Release of Biological Products (Board Order No. 11) (BiolProdRegs – English, unofficial translation) (July 13, 2004)
China Food and Drug Administration, People’s Republic of China

Relevant Section: Chapter I (Article 2)

(3) (Regulation) Interim Measures for the Administration of Human Genetic Resources (AdminHumanGen – Standard Chinese/Zhōngwén) (June 10, 1998) Ministry of Science and Technology and Ministry of Health, People’s Republic of China

Relevant Sections: Chapter One (Article 2)

Specimens > Import & Export
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

Overview
As set forth in the DAL, the RegImplemDAL, the PDR, the PDI, the G-ImprtTherBiolReg, and the G-ImprtPrevBiolReg, all drugs imported for human use are required to be registered with the China Food and Drug Administration (CFDA) prior to being imported. As earlier stated in the Definition of Specimen subtopic, the DAL includes biological products in China’s definition of drug products. The PDR and Additional Resource (A) also state that a Chinese legal entity must submit the drug registration application. Overseas drug manufacturers without legal representation in China must apply for product registration through an agent with professional knowledge and familiarity with Chinese laws and regulations.

According to the G-ImprtTherBiolReg, and the G-ImprtPrevBiolReg, and Additional Resource (A), biological products are classified as either therapeutic or preventive biological products. Each category has a unique classification system and registration requirements. Applicants must complete an Imported Drug Registration Application Form.  For detailed therapeutic and preventive biological product documentation requirements, see the G-ImprtTherBiolReg, the G-ImprtPrevBiolReg, and Additional Resource (A).

The imported drug application submission process follows the same procedures discussed in detail in the Clinical Trial Lifecycle topic, Timeline of Review subtopic. Please refer to this topic for an in-depth discussion of this process. One difference does exist in how much time the National Institutes for Food and Drug Control (NIFDC)  requires to review special drugs and vaccine products. As per the G-ImprtTherBiolReg and the G-ImprtPrevBiolReg, the NIFDC requires 115 days to review these products as compared to the 85 days normally required to review other drug samples.

CFDA Biological Product Lot Release Requirements
As delineated in the BiolProdRegs, a drug manufacturer must also obtain a Certificate of Lot Release of Biological Products from the CFDA to import biological products into China. The BiolProdRegs states that the lot release of biological products is a system by which the CFDA implements mandatory testing and examination for each lot of vaccine products, blood products, in vitro diagnostic reagents for blood donor screening, and other biological products prior to approving the products for marketing or importation. Any product that fails to pass the lot release testing or the examination process will not be permitted to be imported.

According to the BiolProdRegs, a drug manufacturer must submit the following documents and samples to the CFDA at the time of applying for lot release:

  • Application form for lot release of biological products
  • Summary protocol for lot production, and testing signed by the head of the quality assurance department of the drug manufacturer and affixed with the department seal
  • Samples of same lot required for testing
  • Other documents relating to product quality
  • Proof documents for lot release issued by the drug regulatory authority of the country of production along with the corresponding Chinese translation for imported vaccine products

After the CFDA receives the application for lot release, the drug testing institute (the NIFDC or a corresponding drug testing institute based in a province, autonomous region, or municipality), commences preliminary review of the application to determine within five (5) days whether the application should be accepted.

Once the application is accepted, the drug testing institute is required to complete the lot release testing or examination within 55 days for vaccines, 30 days for blood products, and 15 days for reagents for blood donor screening. The CFDA then makes a final decision based upon the institute’s findings. If all the requirements have been met, the CDFA will issue a certification document for lot release to the drug manufacturer.

See the BiolProdRegs for additional information on application requirements and the review process.

In addition to the BiolProdRegs requirements, the PDR also states that any vaccines, blood products, and other biological products to be used in a clinical trial must be tested and found to be qualified by a CFDA-approved drug testing institute, and samples from three (3) production batches must be collected for the testing of biological products.

Human Genetic Resources Export Requirements
As per the AdminHumanGen, the Human Genetic Resources Administration of China (HGRAC) is responsible for reviewing and approving applications to export human genetic materials. According to the AdminHumanGen and Additional Resource (B), the HGRAC was jointly established by the Ministry of Science and Technology (MOST) and the Ministry of Health (renamed the National Health and Family Planning Commission (NHFPC) of the People’s Republic of China in 2013) within the State Council of the People's Republic of China. In addition, the HGRAC is tasked with reviewing and approving applications submitted by any Chinese collaborating party interested in conducting international collaborative projects involving human genetic resources in China. The HGRAC reviews these applications to engage in international collaborative projects and the applications to export human genetic materials on a quarterly basis.

See the AdminHumanGen for HGRAC responsibilities and detailed application document submission requirements.

ADDITIONAL RESOURCES

(A) (Guideline) Importing Pharmaceutical Products to China (July 2014)
EU SME Centre, Beijing, China

Relevant Sections: Imported Drugs Need Pre-market Approval Before Entering the Chinese Market; Biological Products Registration; Annexes 2 and 3; and Links to the Chinese Administration Webpages

(B) (Presentation) Bayer’s Experience in Sample Exportation from China (September 2014)
Beekman, Johanna and Wang, Cheng (Andy), Bayer Pharmaceuticals

Relevant Sections: Definitions, Sample Exportation in China, HGRAC Export Application Process, and Master Application Document Request List

REQUIREMENTS

(1) (Legislation) Drug Administration Law of the People’s Republic of China (Order No. 45) (DAL) (Effective Date: December 1, 2001)
National People’s Congress, People’s Republic of China

Relevant Sections: Chapter V (Articles 29, 39, 40, and 41)

(2) (Regulation) Regulations for Implementation of the Drug Administration Law of the People’s Republic of China (Decree No. 360) (RegImplemDAL) (Effective Date: September 15, 2002)
State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter V (Article 29, 36, 38, 39, and 42)

(3) (Legislation) Provisions for Drug Registration (Order No. 28) (PDR) (Standard Chinese/Zhōngwén) (Effective Date: October 1, 2007)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapter I (Article 5), Chapter II (Articles 10 ,11, and 12), and Chapter VI (Section 1)

(4) (Legislation) Provisions for Drug Importation (PDI – English, unofficial translation) (March 20, 2012)
China Food and Drug Administration, State Council of the People’s Republic of China, People’s Republic of China

Relevant Sections: Chapters 1-5

(5) (Guidance) Verification and Issuance of Registration Certificates for Imported Therapeutic Biological Products (Incl. from Hong Kong, Macao, and Taiwan) (G-ImprtTherBiolReg) (Standard Chinese/Zhōngwén) (December 6, 2013)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: II, VI, VII, VIII, IX, X, and XI

(6) (Guidance) Examination & Approval for Clinical Trials of Imported (incl. from Hong Kong, Macao, and Taiwan) Preventive Biological Products (G-ImprtPrevBiolReg) (Standard Chinese/Zhōngwén) (December 6, 2013)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: II, VI, VII, VIII, IX, X, and XI

(7) (Regulation) Provisions for Lot Release of Biological Products (Board Order No. 11) (BiolProdRegs – English, unofficial translation) (July 13, 2004)
China Food and Drug Administration, People’s Republic of China

Relevant Sections: Chapter I (Articles 2, 8, 11, 16, and 17) and Chapter 3 (Article 21)

(8) (Regulation) Interim Measures for the Administration of Human Genetic Resources (AdminHumanGen – English, unofficial translation) (June 10, 1998)
Ministry of Science and Technology and Ministry of Health, People’s Republic of China

Relevant Sections: Chapters Two and Three

Specimens > Consent for Specimens
Back to Top
Email section Share    Print section Print
Last content review/update: April 30, 2015. Submit updates or comments.
SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Please help us understand our users better by providing your organizational affiliation.
Thank you for providing your affiliation information.
OMB #: 0925-0668
Expiration Date: 2/28/2019