Ministry of Health and Public Hygiene (MSHP)

As delineated in PharmLaw-GIN, the Ministry of Health and Public Hygiene (Ministère de la Santé et de l'Hygiène Publique (MSHP)) is the regulatory authority responsible for national drug marketing authorization. Per DecreeNoD218, the MSHP is responsible for the regulation of clinical trials in the Republic of Guinea. Per GIN-1, the two (2) branches within the MSHP directly involved with the clinical trial approval process are the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) and the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)). Per DecreeNoD218, CNERS is in charge of the clinical trial application review and approval process for studies conducted in humans, and per GIN-1, the DNPM is responsible for drug product registration, authorization, and importation.

National Directorate of Pharmacy and Medicine (DNPM)

Per GIN-20, the DNPM’s mission is to develop and monitor the implementation of government policy in the area of pharmacy and medicine. The DNPM’s responsibilities associated with this mission are as follows:

• Developing the elements of the drug and pharmacy policy
• Monitoring the implementation of the policy at all levels of the country's health system
• Developing regulatory texts relating to pharmacy and medicine
• Organizing a rational and sustainable supply system for the supply of essential medicines for all health structures in the country
• Organizing the quality control of drugs and biological products
• Organizing and supervising pharmacovigilance to safeguard public health
• Monitoring the application of international conventions on narcotic drugs and psychotropic substances
• Developing information and continuing education documents for health professionals
• Promoting essential research in the field of pharmacy and medicine

Per GIN-20 and GIN-9, to carry out its mission, the DNPM is comprised of two (2) divisions: the Medicines Division and the Division of Pharmaceutical Establishments & Laboratories.

As indicated in GIN-9, the Medicines Division’s responsibilities include managing the approval and import of drug products; overseeing drug economics including the supply and production of drug products; addressing pharmacovigilance and other vigilance activities; and monitoring narcotics and psychotropics on the national level. The Pharmaceutical Establishments and Laboratories Division’s responsibilities include overseeing regulations, standards, and approvals relating to pharmaceutical establishments and laboratories; managing the promotion and development of the pharmaceutical industry; addressing quality assurance and the fight against falsified medicines and illicit marketing; and implementing programs to address pharmaceutical logistics in Guinea. See GIN-9 for detailed division information.

National Ethics Committee for Health Research (CNERS)

For detailed information on CNERS’ responsibilities, composition, procedures, and fees, please refer to the Ethics Committee topic.

Other Considerations

According to GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7).

Please note: Guinea is party to the Nagoya Protocol on Access and Benefit-sharing (GIN-3), which may have implications for studies of investigational products developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see GIN-10.

Contact Information

Overview

According to DecreeNoD218, Guinea-PHC, and GIN-5, the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) must approve the health research protocol involving human participants before a clinical trial can commence. Furthermore, according to GIN-1, the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)) must issue a drug import license prior to the sponsor or the representative (typically the principal investigator (PI)) initiating the clinical trial.

According to GIN-1, CNERS must approve the clinical trial protocol before the drug import license application is submitted to the DNPM. Therefore, the CNERS and DNPM reviews may not be conducted in parallel.

Clinical Trial Review Process

According to GIN-1, the sponsor or the designated representative (typically the PI) is responsible for hand delivering the drug import license application to the DNPM’s Pharmacovigilance, Drugs and Quality Control section for review and approval. The DNPM may request drug samples for testing and evaluation even if the PI or the sponsor provides detailed proof of testing and licensing from regulatory authorities based abroad. (See the Submission Process and Submission Content sections for submission requirements, and the Timeline of Review section for review timelines.)

National Directorate of Pharmacy and Medicine (DNPM)

Per GIN-1, the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)) does not charge a fee to review the drug import license application. However, at times there may be related processes that the applicant must follow, which may include fees. Contact the DNPM for more information.

Overview

According to DecreeNoD218, Guinea-PHC, and GIN-5, the principal investigator (PI) must obtain ethics committee (EC) approval to conduct health research involving human participants from the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) before a clinical trial can commence. As per DecreeNoD218, CNERS operates under the Ministry of Health and Public Hygiene (Ministère de la Santé et de l'Hygiène Publique (MSHP)). According to the Guinea-PHC and GIN-5, CNERS is responsible for reviewing and approving clinical research protocols for studies conducted in humans. Per GIN-13, CNERS is also responsible for ensuring research is conducted in accordance with the provisions of the Code of Ethics for Health Research which have been incorporated into Guinea-PHC, for proposing amendments, and for examining ethical issues related to health research submitted by institutions or individuals. In addition to conducting research in compliance with the Guinea-PHC, per GIN-5, CNERS must also comply with the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (GIN-7), the Declaration of Helsinki (GIN-23), the Council for International Organizations of Medical Science (CIOMS)’ International Ethical Guidelines for Biomedical Research Involving Human Subjects (GIN-24), and the World Health Organization (WHO)’s Operational Guidelines for Ethics Committees that Review Biomedical Research (GIN-25).

Ethics Committee Composition

As specified in DecreeNoD218, CNERS consists of 17 members appointed by the MSHP Minister, including an executive office responsible for coordinating committee activities, ensuring its proper functioning, and holding regular meetings. The executive office is comprised of a president, a vice president, and two (2) secretaries. However, GIN-13 states that the executive office is comprised of five (5) members elected within CNERS: a president, a vice-president, a secretary general (held by the Section Head in charge of Research at the MSHP), a secretary in charge of following up on protocol implementation, and a treasurer. Committee members are selected for their interest in research ethics, and for their qualifications and experience in reviewing and evaluating the scientific, medical, and ethical aspects of proposed clinical trials. CNERS strives to bring together health professionals, as well as non-specialists, to represent the social strata and moral values of the national community, and may include doctors, epidemiologists, pharmacists, statisticians, public health specialists, representatives of ministries of health and justice, training and research institutions, religious denominations, non-governmental organizations (NGOs), and patient associations.

As delineated in DecreeNoD218, CNERS composition specifically includes:

• Two (2) members representing Guinea’s main religions (Islam and Christianity)
• Eight (8) members with professional health research qualifications including doctors, clinicians, epidemiologists, biologists, chemists, statisticians, and methodology and research ethics experts
• Seven (7) members representing organizations including health professional associations, relevant ministerial departments, research institutions, non-governmental organizations, and human rights organizations

Per GIN-13, the committee’s activities include the following:

• Receive research protocols and correspondence for CNERS’s review
• Manage the documentation and archives of CNERS
• Help the committee prepare for its sessions
• Write committee meeting minutes
• Disseminate CNERS recommendations and decisions

CNERS has three (3) technical working committees: one (1) committee deals with advocacy, communication, and awareness actions; one (1) committee is responsible for training activities; and one (1) committee is responsible for monitoring and evaluating CNERS’s achievements.

Terms of Reference, Review Procedures, and Meeting Schedule

According to DecreeNoD218, the CNERS committee is required to follow standard operating procedures (SOPs) specifying the conditions for organizing and convening committee meetings and delineating member rights and responsibilities. See GIN-5 for the SOPs.

As specified in DecreeNoD218, the president (also known as the chairman) shall convene CNERS committee sessions, appoint rapporteurs to present the files/protocols submitted to the committee, and determine the matters to be discussed in the session. While DecreeNoD218 specifies that the CNERS committee meets in regular sessions two (2) times a year, the more current GIN-6 indicates that the committee meets in regular sessions on the last Thursday of each month. Per DecreeNoD218 and GIN-12, additional sessions are convened by the president as necessary.

GIN-6 indicates that applications submitted during the first week of each month will be discussed at the regular monthly meeting. It also explains that a minimum of three (3) weeks is required between the submission and its review by CNERS. The CNERS Administrative Assistant will provide the applicant an acknowledgement of receipt and keep all files in the CNERS archives. GIN-12 states that committee members should have a copy of the protocol for review at least six (6) working days before the committee session.

DecreeNoD218 states that the appointment of CNERS committee members is valid for three (3) years and is renewable. Members must have no conflict of interest with the protocols under review. GIN-5 indicates that the quorum required for voting is nine (9) members. Per GIN-5, if necessary, CNERS may use independent consultants to provide specific expertise in reviewing the proposed research protocols. These consultants may be specialists in ethics, law, in a particular disease or methodology, or be representatives of specific communities, patients, or special interest groups. If necessary, CNERS can also invite the PI. Further, GIN-13 recommends changing one-third of the membership at a time, which helps to train new members and remain efficient during the transition.

For detailed CNERS procedures and information on other administrative processes, see DecreeNoD218 and GIN-5.

Overview

According to DecreeNoD218, the Guinea-PHC, and GIN-5, the mission of the National Ethics Committee for Health Research (Comité National d’Ethique pour la Recherche en Santé (CNERS)) is to ensure the scientific quality and ethical conduct of health research in the Republic of Guinea. As per the Guinea-PHC and GIN-5, the primary scope of information assessed by CNERS relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial. GIN-6 requires the principal investigator (PI) to respect the fundamental ethical principles of research involving human beings.

As per the Guinea-PHC and GIN-5, CNERS must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable. DecreeNoD218, the Guinea-PHC, and GIN-5 also state that CNERS is responsible for ensuring an independent, timely, and competent review of all ethical aspects of the clinical trial protocol. They must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants, and they must verify the adequacy of confidentiality and privacy safeguards. See the Guinea-PHC and GIN-5 for detailed ethical review guidelines.

Role in Clinical Trial Approval Process

As per the Guinea-PHC, GIN-6, and GIN-5, the PI or the representative is responsible for submitting a research application to CNERS for review and approval. According to GIN-1, CNERS must approve the clinical trial protocol before the sponsor or the representative (typically the PI) submits the drug import license application to the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)). Therefore, the CNERS and DNPM reviews may not be conducted in parallel.

GIN-6 and GIN-5 provide specific requirements for the submission of research by the PI, as well as the details pertaining to the CNERS review and decision-making process. Please refer to the Timeline of Review section for additional ethics committee (EC) timeline information.

Per GIN-5 and GIN-12, CNERS approval is valid for one (1) year and is renewable upon request by the PI/sponsor. Additionally, per GIN-12 and GIN-6, any amendments to protocols currently being implemented must also be submitted to CNERS.

Guinea-PHC states that when research is related to an epidemic or calamity, the proposal must be submitted within 30 days from the project’s filing date. GIN-5 further states that in emergencies (e.g., epidemics or disasters), an accelerated procedure is adopted without prejudice to the requirements of submitting the protocol and including the following:

• Reduction of the minimum and maximum periods of review and decision to 48 hours and one (1) week respectively
• Reduction of the required quorum of the members of CNERS to five (5)
• Possibility of calling on other national and international experts
• Acceptances of online submission and evaluation
• Sending the response letter within 48 hours after evaluation

Per GIN-5, the EC should conduct a monitoring and evaluation visit for all approved research projects. Urgent follow-up visits may also be prompted by the following:

• Any protocol amendment likely to affect the rights, safety, and/or well-being of the participants or the conduct of the research
• Serious or unexpected adverse events related to the conduct of the research or the product tested
• Actions taken by investigators, sponsors, and regulatory bodies
• Any event or new information likely to modify the benefit/risk ratio of the research
• A decision of an independent safety committee

Furthermore, in the event of serious shortcomings observed in the field (non-compliance with the protocol or modification of the latter), CNERS may suspend the implementation of the project. In this case, a new protocol will be submitted to CNERS for review.

National Ethics Committee for Health Research (CNERS)

As per GIN-6, the principal investigator is responsible for paying a fee of 5,000,000 Guinean Francs to the National Ethics Committee for Health Research (Comité National d’Ethique pour la Recherche en Santé (CNERS)) to review and approve the clinical trial protocol and related documents. For protocol amendments or extension of approval validation, the fee is 3,000,000 Guinean Francs. For doctoral students, the fee for amending a protocol or extending the validation of approval is 1,500,000 Guinean Francs.

Payment Instructions

Per GIN-17, payment to CNERS can be made by bank transfer, check, or cash depending on the options available to the applicant. GIN-5 further notes that when the investigator submits the documents to be examined to the CNERS secretariat, an acknowledgement of receipt and a payment receipt will be sent to the investigator.

Overview

Per DecreeNoD218, the Ministry of Health and Public Hygiene (Ministère de la Santé et de l’Hygiène Publique (MSHP)) is the authorizing body of the National Ethics Committee for Health Research (Comité National d’Ethique pour la Recherche en Santé (CNERS)). CNERS is responsible for reviewing and approving clinical research protocols for studies conducted in humans at the national level.

Registration, Auditing, and Accreditation

According to GIN-1, CNERS is accredited by the MSHP.

Overview

In accordance with DecreeNoD218, Guinea-PHC, and GIN-5, the principal investigator (PI) must obtain approval to conduct health research involving human participants from the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) before a clinical trial can commence. In addition, per GIN-1, the sponsor or the representative (typically the PI) is responsible for obtaining a drug import license from the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)) prior to initiating a study.

According to GIN-1, CNERS must approve the clinical trial protocol before the drug import license application is submitted to the DNPM. Therefore, the CNERS and DNPM reviews may not be conducted in parallel. Additionally, according to GIN-12 and GIN-6, any amendments to protocols currently being implemented must also be submitted to CNERS.

Regulatory Submission

According to GIN-1, the sponsor or the representative (typically the PI) should hand deliver one (1) hard copy of the drug import license application along with other required documentation to the DNPM’s Division of Pharmaceutical Products. (Refer to the Submission Content section for submission documentation information.)

Ethics Review Submission

As per GIN-6, eight (8) hard copies and an electronic copy of the clinical trial application and accompanying materials should be submitted to CNERS. The application and supporting materials text must be in Arial 12 font. Each hard copy must have all the materials bound together, and the electronic copy must be transmitted in a single file. See GIN-6 for the application form and the Submission Content section for detailed documentation requirements.

According to GIN-6, the clinical trial application and accompanying materials, must be provided in French.

Per GIN-6 and GIN-21, the CNERS application and all related documents must be submitted to the CNERS headquarters located within the Dixinn BlueZone, next to the Kenien bridge on the highway. Contact Ms. Diallo Aissatou BAH, by phone at +224 622 25 31 27 or +224 628 77 72 23, email: aissatou_dalaba07@yahoo.fr.

Please refer to the Ethics Committee section for more information regarding CNERS requirements.

Regulatory Authority Requirements

Per GIN-1, the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)) does not have a drug import license application form. Rather, the application is comprised of the materials submitted by the sponsor or the representative (typically the principal investigator (PI)) along with a request to obtain a drug import license.

Per GIN-1, along with the application, the sponsor or the representative must submit the following:

• One (1) copy of the protocol
• Ethical approval
• Informed consent form (ICF)
• Investigator(s) curriculum vitaes (CVs)
• Investigator’s Brochure (IB)
• All investigational product (IP) documentation
• Product license request

Ethics Committee Requirements

According to GIN-6, the National Ethics Committee for Health Research (Comité National d’Ethique pour la Recherche en Santé (CNERS)) requires eight (8) hard copies and an electronic copy of each of the documents listed below:

• Research protocol submission letter, dated and signed by the PI
• Completed ethics review application form, dated and signed by the PI (see GIN-6)
• Protocol
• ICF and/or assent form
• Data collection instruments
• IB
• Detailed project budget in Guinean francs
• Profile of investigators in five (5) lines
• CVs for all investigators (four (4) pages maximum per CV)
• Previous related decisions from CNERS and/or other countries
• Letters from associated partners
• Other documents

In addition to the documents indicated by GIN-6, GIN-5 also states that CNERS requires the following documents:

• Table of contents
• Acronyms and abbreviations
• Project summary in a maximum of 10 lines
• Research problem, objectives, and hypotheses
• Research sponsor(s) profile(s) and CV(s)
• Methodology including sampling
• Ethical considerations
• Data collection tools (including material(s) used to inform and recruit participants (e.g., posters, messages, image boxes, etc.) dated and with a version number, and translated into the relevant languages according to the target population of the study)
• Participant compensation mechanism as well as the benefits related to the research
• Measures taken to mitigate research-related risks
• Measures taken to ensure participant(s) compensation in the event of injury
• Data analysis techniques and tools
• Documents relating to free and informed consent including: description of the strategies for recruiting participants and obtaining consent; participant protection and data privacy measures; presentation of risks faced by individuals and communities
• Methods for sharing results (including publications), data, and biological materials collected in Guinea and transferred outside
• Involvement of health authorities and communities
• Methods for sharing research benefits with research populations
• Activities schedule
• Bibliographic references
• IB, if applicable, together with published data and a summary of product characteristics
• Details of changes made to the protocol since the last notice was issued
• Sponsor and PI declaration to respect ethical principles and standards

See GIN-6 for detailed requirements related to corrections, amendments, and renewal of approvals.

Clinical Protocol

As indicated in the Guinea-PHC, any clinical research protocol must contain the following elements:

• Identity of the sponsor and investigator
• Research objectives and hypotheses
• Methodology
• Calculation of the number of participants necessary, and inclusion/exclusion criteria
• Method of data analysis
• Criteria to decide end of study
• Potential risks to participants
• Ethical aspects
• Informed consent procedures

See the Guinea-PHC for additional details regarding protocol elements.

In addition, per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7). Accordingly, GIN-7 requires the following protocol contents:

• General information (protocol title, identifying number, and date; contact information for the sponsor, medical expert, investigator(s), trial site(s), qualified physician(s), and laboratory and/or institutions involved in the study)
• Background information
• Objectives and purpose
• Trial design
• Selection, withdrawal, and treatment of participants
• Assessment of efficacy
• Assessment of safety
• A description of the statistical methods to be used in the trial
• Direct access to source data and documents
• Quality control and quality assurance
• Ethical considerations
• Data handling and recordkeeping
• Publication policy

Overview

According to GIN-1, the National Ethics Committee for Health Research (Comité National d’Ethique pour la Recherche en Santé (CNERS)) must approve the clinical trial protocol before the drug import license application is submitted to the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)). Therefore, the CNERS and DNPM reviews may not be conducted in parallel.

Regulatory Authority Approval

According to GIN-1, the DNPM’s approval of a drug import license application typically takes two (2) weeks.

Ethics Committee Approval

Per the Guinea-PHC, CNERS must give its opinion on any research protocol submitted within a period not exceeding 60 days from the project’s filing date. GIN-5 and GIN-12 indicate that the sponsor or principal investigator (PI) who submitted the protocol will be notified of the opinion of CNERS within 10 days of the committee meeting via email.

GIN-5 specifies that the PI is required to submit a research protocol to CNERS at least 15 days prior to the committee meeting for the application to be reviewed during the current month. However, this period may be expedited for health emergency reasons. GIN-6 similarly indicates that a minimum of three (3) weeks is required between the submission and its review by CNERS. GIN-6 further states that applications submitted during the first week of each month will be discussed at the regular monthly meeting which occurs on the last Thursday of each month. GIN-5 explains that the file must include all required documents for it to be admissible and evaluated by the committee (See the Submission Content section for the list of required documents.)

Per GIN-6, the CNERS Administrative Assistant will provide the applicant an acknowledgement of receipt and keep all files in the CNERS archives. GIN-12 states that committee members should have a copy of the protocol for review at least six (6) working days before the committee session. Per the Guinea-PHC, CNERS must give its opinion on any research protocol submitted within a period not exceeding 60 days from the project’s filing date. GIN-5 and GIN-12 indicate that the sponsor or PI who submitted the protocol will be notified of the opinion of CNERS within 10 days of the committee meeting via email and that CNERS approval is valid for one (1) year and is renewable upon request by the PI/sponsor.

Special Circumstances

Guinea-PHC states that when research is related to an epidemic or calamity, the proposal must be submitted within 30 days from the project’s filing date. GIN-5 further states that in emergencies (e.g., epidemics or disasters), an accelerated procedure is adopted without prejudice for the protocol submission requirements and includes the following:

• Reduction of the minimum and maximum periods of review and decision to 48 hours and one (1) week respectively
• Reduction of the required quorum of CNERS members to five (5)
• Possibility of calling on other national and international experts
• Acceptance of online submissions and evaluations
• Sending the response letter within 48 hours after evaluation

Overview

In accordance with DecreeNoD218, Guinea-PHC, and GIN-5, the principal investigator (PI) must obtain approval to conduct health research involving human participants from the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) before a clinical trial can commence. In addition, per GIN-1, the sponsor or the representative (typically the PI) is responsible for obtaining a license to import study drugs from the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)) prior to initiating a study. No waiting period is required following the sponsor’s receipt of these approvals.

Per GIN-17, the research should comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7).

Clinical Trial Agreement

Furthermore, per GIN-7, the sponsor should obtain the investigator’s/institution’s agreement to:

• Conduct the trial in compliance with Good Clinical Practice (GCP), the applicable regulatory requirement(s), and the approved protocol
• Comply with procedures for data recording/reporting
• Permit monitoring, auditing, and inspection
• Retain the trial-related essential documents until the sponsor informs the investigator/institution these documents are no longer needed

The sponsor and the investigator/institution should sign the protocol, or an alternative document, to confirm this agreement.

Clinical Trial Registration

According to GIN-1, the Ministry of Health and Public Hygiene (Ministère de la Santé et de l'Hygiène Publique (MSHP)) does not currently require the clinical trial to be registered with either a domestic or international clinical trial registry.

Safety Reporting Definitions

Per G-PV-GIN, the following definitions provide a basis for a common understanding of Guinea’s safety reporting requirements:

• Adverse Event (AE) – Any harmful and unintended manifestation occurring in a subject during treatment. The term "adverse event", unlike "adverse effect", does not prejudge a causal link with exposure, particularly to a drug.
• Adverse Reaction (AR) – A harmful and unintended reaction to a drug or other health product, occurring at dosages normally used in humans for the prophylaxis, diagnosis, or treatment of disease or for the recovery, rectification, or modification of a physiological function, or resulting from misuse of the drug or product
• Adverse Drug Effect (ADR) – A harmful and unwanted reaction, occurring at dosages normally used in humans for the prophylaxis, diagnosis, or treatment of a disease or the modification of a physiological function or resulting from a misused drug, constituting a withdrawal syndrome when stopping the product or a dependency syndrome, as well as any reaction resulting from misuse. It also includes any harmful reactions that may arise from poor quality of the drug
• Serious Adverse Event (SAE) – An adverse effect that is lethal, or likely to be life-threatening, resulting in disability or incapacity, or causing or prolonging hospitalization, or resulting in a congenital anomaly
• Unexpected Adverse Drug Reaction – An adverse reaction whose nature, severity, or outcome does not correspond with the known authorized information for this medicinal product

As delineated in G-PV-GIN, Guinea’s pharmacovigilance system is coordinated by the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)) according to the provisions in PharmLaw-GIN. G-PV-GIN is based on the GIN-7 guidelines, and may also contain additional requirements in accordance with the legislation in force. The National Pharmacovigilance System includes the National Pharmacovigilance Commission, the National Pharmacovigilance Technical Committee, the Pharmacovigilance Section of the National Directorate of Pharmacy and Medicine, the pharmacovigilance focal points at each level of the health pyramid, health programs, pharmaceutical companies, and the public. See G-PV-GIN for additional details).

Safety Reporting Requirements

As delineated in G-PV-GIN, pharmaceutical companies are required to notify the DNPM of SAEs/serious adverse drug reactions (SADRs) occurring during a clinical trial within seven (7) days. Additionally, the DNPM should be notified of any new fact likely to harm the safety of the participants participating in the trial 15 days following first knowledge of the sponsor. Non-serious AEs will be transmitted to the DNPM in the clinical study final report.

Per G-PV-GIN, clinical trial applicants are required to notify the DNPM of the following:

• Any AE (including symptoms and clinical signs)
• Changes in biological values (e.g., hypoglycaemia, etc.) or medication errors
• Therapeutic failures
• Drug interactions
• Any observation of overdose, abuse, or misuse
• Any problem related to exposure during pregnancy or breastfeeding
• Any observation of loss of efficacy, in particular with vaccines, contraceptives, or other pharmaceutical products intended for the treatment of diseases involving life-threatening conditions
• Any other effect deemed relevant to declare

G-PV-GIN specifies that all serious and unexpected AEs/ADRs that are fatal or life-threatening, as well as those occurring during a clinical trial, must be notified to the DNPM expeditiously, i.e., as soon as the notifier becomes aware of them or within a period not exceeding 48 hours. Update notes may be provided within an additional period not exceeding 7-15 days. All other serious or unexpected AEs/ADRs must be reported immediately, but within a period not exceeding seven (7) days. The count of days starts from the moment when the notifier becomes aware of the suspected AE/ADR and the minimum conditions for notification are met.

Per G-PV-GIN, the pharmaceutical industry must also report serious or unexpected AEs/ADRs within 24-48 hours, deaths within 24 hours, and non-serious AEs/ADRs monthly. Health professionals are required to report serious or unexpected AEs/ADRs within 24-48 hours, deaths are to be reported immediately, and non-serious AEs/ADRs should be reported as soon as possible, not to exceed seven (7) days.

Investigator Responsibilities

According to GIN-5, the principal investigator (PI) must report serious and unexpected AEs to the National Ethics Committee for Health Research (Comité National d’Ethique pour la Recherche en Santé (CNERS)) for review.

According to GIN-17, CNERS does have an AE/ADR database, however, an electronic link is not available nor is any other information regarding the database at this time.

Ethics Committee Responsibilities

As indicated in GIN-5, the ethics committee should assess the AEs that have occurred, the measures taken for the participant’s safety, and the information from CNERS (pharmacovigilance file).

Form Completion & Delivery Requirements

Per GIN-17, since CNERS has not yet developed a specific AE/ADR form, researchers should complete their own AE/ADR notification form and submit it to CNERS for review. Researchers submit completed AE/ADR notification forms to CNERS for review. No further information is available regarding delivery requirements.

G-PV-GIN notes all AE/ADR notifications are made on the national notification form designed by the DNPM. Refer to G-PV-GIN for form details.

In addition, per G-PV-GIN, Guinea also submits ADR notifications via the VigiFlow database (GIN-16). Per GIN-15, GIN-16 is a web-based platform developed by the World Health Organization (WHO)’s Uppsala Monitoring Centre to help countries manage AEs/ADRs. See GIN-15 for detailed information on VigiFlow, and see GIN-18 for submission instructions.

Interim and Annual Progress Reports

According to GIN-5, the principal investigator (PI) is responsible for submitting a progress report on the status of a clinical trial to be evaluated by the National Ethics Committee for Health Research (Comité National d’Ethique pour la Recherche en Santé (CNERS)). In addition, per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7), which states the investigator should promptly provide written reports to the sponsor and the institutional ethics committee, and where applicable, the institution, on any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants.

Final Report

Per GIN-5, the PI is responsible for submitting a final study report upon the trial’s completion to be evaluated by CNERS.

Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7), which defines a sponsor as an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.

In accordance with GIN-7, Guinea permits a sponsor to transfer any or all of its trial-related duties and functions to a contract research organization (CRO) and/or institutional site(s). However, the ultimate responsibility for the trial data’s quality and integrity always resides with the sponsor. Any trial-related responsibilities transferred to a CRO should be specified in a written agreement. The CRO should implement quality assurance and quality control.

Overview

Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7), which provides guidance to sponsors on investigator and site selection. According to GIN-7:

• The sponsor is responsible for selecting the investigator(s)/institution(s). Each investigator should be qualified by training and experience and should have adequate resources to properly conduct the trial for which the investigator is selected. If the organization of a coordinating committee and/or selection of coordinating investigator(s) are to be utilized in multicenter trials, their organization and/or selection are the sponsor’s responsibility.
• Before entering an agreement with an investigator/institution to conduct a trial, the sponsor should provide the investigator(s)/institution(s) with the protocol and an up-to-date Investigator’s Brochure, and the investigator/institution should be provided with sufficient time to review the materials.

Foreign Sponsor Responsibilities

No information is available regarding foreign sponsor regulatory requirements.

Data and Safety Monitoring Board

Per GIN-7, a Data and Safety Monitoring Board (DSMB) may be established to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial.

Multicenter Studies

As delineated in GIN-7, in the event of a multicenter clinical trial, the sponsor must ensure that:

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

In addition, the sponsor is responsible for the organization of a coordinating committee and/or selection of coordinating investigator(s), if they are to be utilized.

Insurance

According to GIN-17, sponsors must submit proof of insurance as part of the clinical trial application submission to the National Ethics Committee for Health Research (Comité National d’Ethique pour la Recherche en Santé (CNERS)).

Compensation

Injury or Death

According to the Guinea-PHC, in the event of any temporary or permanent trial-related injury or disability, the participant should be compensated. In the case of the participant’s death, the legal heirs are entitled to financial compensation.

In addition, per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7), which provides guidance for sponsors on providing compensation to research participants in the event of trial-related injuries or death. The sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries.

Trial Participation

Per GIN-7, the participant should be provided with information regarding any anticipated prorated payment, if any, for participating in the trial.

Quality Assurance/Quality Control

Per GIN-17, Guinea is required to comply with the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (GIN-7), which provides guidance to sponsors on quality, data, and records management.

GIN-7 indicates that the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results. The quality management system should use a risk-based approach that includes:

• During protocol development, identifying processes and data that are critical to ensure participant protection and the reliability of trial results
• Identifying risks to critical trial processes and data
• Evaluating the identified risks against existing risk controls
• Deciding which risks to reduce and/or which risks to accept
• Documenting quality management activities and communicating to those involved in or affected by these activities
• Periodically reviewing risk control measures to ascertain whether the implemented quality management activities are effective and relevant
• Describing in the clinical study report, the quality management approach implemented in the trial and summarizing important deviations from the predefined quality tolerance limits and remedial actions taken

Monitoring Requirements

Per GIN-7, the sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The extent and nature of monitoring is flexible and permits varied approaches that improve effectiveness and efficiency. The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or where justified, centralized monitoring. The sponsor should document the rationale for the chosen monitoring strategy (e.g., in the monitoring plan).

Premature Study Termination/Suspension

According to GIN-7, if it is discovered that noncompliance significantly affects or has the potential to significantly affect participant protection or reliability of trial results, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions. Further, the ethics committee (EC) should also be informed promptly and provided the reason(s) for the termination or suspension by the sponsor.

Electronic Data Processing System

According to GIN-17, Guinea is required to comply with the International Council for Harmonisation (ICH)’s Guideline for Good Clinical Practice E6(R2) (GIN-7). As per GIN-7, when using electronic trial data processing systems, the sponsor must ensure that the electronic data processing system conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistency of intended performance. The sponsor should base their approach to validate such systems on a risk assessment that takes into consideration the intended use and the potential of the system to affect participant protection and reliability of trial results. In addition, the sponsor should maintain standard operating procedures (SOPs) for the systems that cover system setup, installation, and use. The responsibilities of the sponsor, investigator, and other parties should be clear, and the system users should be provided with training. Refer to GIN-7 for additional information.

Records Management

As set forth in GIN-7, sponsor-specific essential documents should be retained until at least two (2) years after the last approval of a marketing application, until there are no pending or contemplated marketing applications, or at least two (2) years have elapsed since the formal discontinuation of the investigational product’s clinical development. The sponsor should inform the investigator(s) and the institution(s) in writing when trial-related records are no longer needed.

In addition, GIN-7 states that the sponsor and investigator/institution should maintain a record of the location(s) of their respective essential documents including source documents. The storage system used during the trial and for archiving (irrespective of the type of media used) should allow for document identification, version history, search, and retrieval. The sponsor should ensure that the investigator has control of and continuous access to the data reported to the sponsor. The investigator/institution should have control of all essential documents and records generated by the investigator/institution before, during, and after the trial.

Responsible Parties

For the purposes of data protection requirements, the PDPLaw delineates the responsibilities of the “data controller.” The data controller, as defined by the PDPLaw, refers to the natural or legal person, public or private, or any other body or association which, alone or jointly with others, makes the decision to collect and process personal data, and determines the purposes thereof.

Data Protection

Per the PDPLaw, the data controller must be guided by the following principles:

• The collection, recording, processing, storage, transmission, and interconnection of personal data files must be done in a lawful and fair manner
• Personal data must be collected for specified, explicit, and legitimate purposes, and not be further processed in a manner incompatible with these purposes; be adequate, relevant, and not excessive regarding the purposes for which the data are collected and processed; be kept for a period that does not exceed the period necessary for the stated collection or processing purposes; data may only be kept beyond this required period to respond specifically to the process of said data for historical, statistical, or research purposes under the provisions of this law or any other laws or regulations in force regarding personal data protection
• The data collected must be accurate, and if necessary, updated
• The principle of transparency implies mandatory and clear information from the person responsible for processing personal data
• Personal data must be treated confidentially and protected, in particular when the process of this data involves data transmissions in a network
• When personal data processing is implemented on behalf of the data controller, the data controller must choose a subcontractor who is able to provide guarantees for the protection and confidentiality of the data
• The person responsible for processing personal data may only be authorized to transfer said data to a third country if it ensures a higher or equivalent level of protection of the privacy, freedoms, and fundamental rights of persons regarding the processing to which these data are or may be subject; before any actual transfer of personal data to this third country, the data controller must obtain prior authorization from the Personal Data Protection Authority; any transfer of personal data to a third country is subject to strict and regular control by the Personal Data Protection Authority, regarding their purpose

As set forth in PDPLaw, prior authorization from the competent authority (i.e., the Ministry of Health and Public Hygiene (Ministère de la Santé et de l’Hygiène Publique (MSHP)) is required before any implementation of personal data processing relating to:

• Genetic and medical data and scientific research in these fields
• Personal data including biometric data
• Personal data processing for public interest reasons, in particular for historical, statistical, or scientific purposes
• Planned transfer of personal data to a third country

See the PDPLaw for detailed information on data protection requirements in Guinea.

Consent for Processing Personal Data

As set forth in the PDPLaw, personal data processing is considered legitimate if the data subject expressly gives prior consent. However, this prior consent requirement may be waived when the controller is duly authorized and the processing is necessary for: compliance with a legal obligation to which the controller is subject; the performance of a task in the public interest or in the exercise of public authority, vested in the controller or the third party to whom the data is communicated; the execution of a contract to which the data subject is a party or for the execution of pre-contractual measures taken at the subject’s request; or to safeguard the interest or the fundamental rights and freedoms of the data subject.

Per PDPLaw, at the time of the data collection or before, the person responsible for processing personal data is required to provide the data subject the following information:

• The specific purpose(s) of the processing for which the data is intended
• The categories of data concerned
• The recipient(s) to whom the data is likely to be communicated
• The option of refusing to appear on the file in question
• The existence of a right of access to data concerning the person, and a right to rectify this data
• The data retention period
• The possibility of any transfer of data to a third country

In addition, per PDPLaw, the data subject may ask questions and obtain from the data processor the following:

• Information allowing the person to know about and contest the processing
• Confirmation that personal data concerning the data subject is or is not the subject of this processing
• Information relating to the purposes of the processing, the categories of personal data processed and the recipients or categories of recipients to whom the data is communicated

Refer to the PDPLaw for detailed personal data protection consent requirements.

Obtaining Consent

In all Guinean clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in the Guinea-PHC. According to GIN-5 and GIN-6, the informed consent form (ICF) must be reviewed and approved by the National Ethics Committee for Health Research (Comité National d’Ethique pour la Recherche en Santé (CNERS)) with the clinical trial application. Per GIN-5, CNERS should also review modifications/amendments to the ICF and the assent form. (See the Required Elements section for details on what should be included in the form.)

Per the Guinea-PHC, investigator(s) must provide detailed research study information to the participant or legal representative/guardian. The ICF content should be presented in a manner that is easy to understand and without coercion or unduly influencing a potential participant to enroll in the clinical trial.

Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7). As per the Guinea-PHC and GIN-7, a participant should not be coerced or pressured in any way during the consent process. Per GIN-7, none of the oral and written information concerning the trial, including the written ICF, should contain any language that causes the participant or legal representative/guardian to waive or appear to waive any legal rights, or that releases or appears to release the investigator, the institution, the sponsor, or their agents from liability for negligence.

Re-Consent

No information is currently available regarding re-consent requirements.

Language Requirements

According to GIN-6, the clinical trial application and accompanying materials, including the ICF, must be provided in French.

Documenting Consent

As indicated in the Guinea-PHC, the participant or legal representative/guardian must sign and date the ICF before an independent witness.

Per GIN-7, when the participant is illiterate or the legal representative/guardian is illiterate, an impartial witness should be present during the entire informed consent discussion. The witness should sign and date the ICF after the following steps have occurred:

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

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

Waiver of Consent

No information is available on waiver of consent requirements.

Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7), which provides guidance on the elements to include in the informed consent form (ICF). As described in GIN-7, both the informed consent discussion and the written ICF and any other written information to be provided to participants should include explanations of the following:

• The trial involves research
• The purpose of the trial
• The trial treatment(s) and the probability for random assignment to each treatment
• The trial procedures to be followed, including all invasive procedures
• The participant’s responsibilities
• Those aspects of the trial that are experimental
• The reasonably foreseeable risks or inconveniences to the participant and, when applicable, to an embryo, fetus, or nursing infant
• The reasonably expected benefits. When there is no intended clinical benefit to the participant, the participant should be made aware of this.
• The alternative procedure(s) or course(s) of treatment that may be available to the participant, and their important potential benefits and risks
• The compensation and/or treatment available to the participant in the event of a trial-related injury
• The anticipated prorated payment, if any, to the participant for participating in the trial
• The anticipated expenses, if any, to the participant for participating in the trial
• The participant’s participation in the trial is voluntary and the participant may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the participant is otherwise entitled
• The monitor(s), the auditor(s), the ethics committee, and the regulatory authority(ies) will be granted direct access to the participant's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the participant, to the extent permitted by the applicable laws and regulations and that, by signing a written ICF, the participant or legal representative/guardian is authorizing such access
• The records identifying the participant will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, then the participant’s identity will remain confidential
• The participant or legal representative/guardian will be informed in a timely manner if information becomes available that may be relevant to the participant’s willingness to continue participation in the trial
• The person(s) to contact for further information regarding the trial and the rights of trial participants, and whom to contact in the event of trial-related injury
• The foreseeable circumstances and/or reasons under which the participant’s participation in the trial may be terminated
• The expected duration of the participant’s participation in the trial
• The approximate number of participants involved in the trial

Overview

In accordance with the Guinea-PHC, Guinea’s ethical standards promote respect for all human beings and safeguard the rights of research participants. The Guinea-PHC states that a participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. GIN-6 requires the principal investigator to respect the fundamental ethical principles of research involving human beings.

Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7).

The Right to Participate, Abstain, or Withdraw

As set forth in the Guinea-PHC and GIN-7, a potential research participant or legal representative/guardian should be informed that participation is voluntary and that the participant may refuse to participate or withdraw from the research study at any time.

The Right to Information

As delineated in the Guinea-PHC and GIN-7, a potential research participant or legal representative/guardian has the right to be informed about the nature and purpose of the research study, study procedures, obligations associated with the participant’s participation, any potential benefits or risks, and any compensation for participation or injury/treatment.

The Right to Privacy and Confidentiality

As per the Guinea-PHC and GIN-7, all participants must be afforded the right to privacy and confidentiality.

The Right of Inquiry/Appeal

No information is currently available regarding the right of inquiry/appeal.

The Right to Safety and Welfare

The Guinea-PHC and GIN-7 state that a research participant’s right to safety and the protection of the participant’s health and welfare must always take precedence over the interests of science and society.

The Guinea-PHC makes provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by an emergency. As delineated in the Guinea-PHC, in an emergency, when the participant is unable to give informed consent, the consent of a family member should be obtained.

According to GIN-17, Guinea is also required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7). Per GIN-7, in an emergency, if the signed informed consent form (ICF) has not been obtained from the research participant or legal representative/guardian, or if an effective treatment is lacking but the investigational product could address the participant’s emergency needs, the clinical trial may be conducted. However, the method used on the participant must be explained clearly in the trial protocol, and the ethics committee must approve the protocol in advance. The participant or legal representative/guardian should be informed about the trial as soon as possible, and consent to continue and other consent should be requested, as appropriate.

Overview

As per the Guinea-PHC, in all Guinean clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent process. Vulnerable populations include persons who cannot give a fully free and informed consent because of the person’s situation or mental state, and may include, but are not limited to, children/minors, prisoners, physically or mentally handicapped, persons whose condition requires emergency treatment or life support, and pregnant or lactating women.

Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7). GIN-7 includes the following as vulnerable populations: members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable populations include persons in nursing homes, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

Guinea’s definition of a child/minor and the age of consent for children/minors are not specified in the currently available regulatory resources.

In accordance with the Guinea-PHC, when the research participant is a child, the informed consent form (ICF) must be signed by the child’s parent/legal guardian. In the case of disagreement between the wishes of the child and the parent/legal guardian, the child’s wishes should prevail. The child’s personal consent must be requested when the child’s age allows the child to understand the purpose of the research, the risk, and disadvantages of this research, and what is expected of the child’s participation. Research may only be conducted in children if it cannot be conducted in less vulnerable participants, such as for the purpose of researching childhood diseases or pathologies to which children are particularly susceptible.

Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7). GIN-7 states that when a clinical trial includes minors, the minor should be informed about the trial to the extent compatible with their understanding and, if capable, should sign and personally date the written informed consent.

Assent Requirements

No information is currently available regarding assent requirements.

As per the Guinea-PHC, any research studies involving women who are pregnant or nursing require additional safeguards to ensure the research conforms to appropriate ethical standards. The informed consent of the pregnant woman or nursing mother is required for all proposed research studies. Studies to be conducted with this population should meet one (1) or more of the following conditions:

• The research should improve the health of the mother without harming the fetus or infant
• The research should increase the viability of the fetus
• The research should promote the proper development of the infant or the mother’s ability to nurse the infant

The Guinea-PHC further states that any research promoting abortion is prohibited by the Penal Code.

Per GIN-17, Guinea is also required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7). GIN-7 explains that the informed consent form should include a statement on the reasonably foreseeable risks or inconveniences to the participant, and when applicable, to an embryo, fetus, or nursing infant.

According to the Guinea-PHC, prisoners are considered vulnerable because incarceration could affect their ability to make a voluntary decision regarding participation in research. The Guinea-PHC states that prisoners may not participate in any research study while they are detained in prison and deprived of their freedom. Additionally, if an ill person is placed under the responsibility of the judicial authority, the agreement of the latter is required in addition to the informed consent of the participant.

As stated in the Guinea-PHC, participants with a mental impairment are at risk in research studies as they are unable to fully comprehend the nature of the research and the informed consent process. Per the Guinea-PHC, mentally impaired participants should be fully informed about the study in which they have been asked to participate. Informed consent must be obtained from the legal representative/guardian who have been informed about the trial. The refusal of a mentally impaired participant should always be respected. Research may only be conducted in mentally impaired participants if it cannot be conducted in healthy participants.

Per GIN-17, Guinea is also required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7). GIN-7 states that when a clinical trial includes participants with mental impairment (e.g., those with severe dementia), the participant should be informed about the trial to the extent compatible with their understanding and, if capable, should sign and personally date the written informed consent.

Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7). GIN-7 defines an investigational product as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.

Manufacturing

According to GIN-4 and GIN-8, the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)) is responsible for authorizing the manufacture of drug products in Guinea. Specific information concerning the DNPM’s role in reviewing and approving the manufacture of investigational products (IPs) is not currently available.

Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7), which requires IPs to be manufactured, handled, and stored in accordance with applicable Good Manufacturing Practice (GMP) and used in accordance with the approved protocol.

Import

According to GIN-1, once the principal investigator (PI) obtains ethics committee approval from the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)), the sponsor or the representative (typically the PI) must submit a written request along with additional documentation to the DNPM director to obtain approval to import IPs. (See the Submission Content section for detailed documentation requirements.) According to GIN-1, the DNPM’s approval of a drug import license application typically takes two (2) weeks.

Additional information on the DNPM review and approval process is not available at this time.

Please note: Guinea is party to the Nagoya Protocol on Access and Benefit-sharing (GIN-3), which may have implications for studies of IPs developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see GIN-10.

Investigator’s Brochure

Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7).

As specified in GIN-7, the Investigator’s Brochure (IB) must include the following sections:

• Table of Contents
• Summary
• Introduction
• Physical, Chemical, and Pharmaceutical Properties and Formulation
• Nonclinical Studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
• Effects in Humans (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; and regulatory and post-marketing experiences)
• Summary of Data and Guidance for the Investigator(s)

The sponsor should also update the IB as significant new information becomes available. See GIN-7 for detailed content guidelines.

Quality Management

Per GIN-7, the sponsor must maintain a Certificate of Analysis to document the identity, purity, and strength of the IP(s) to be used in the clinical trial.

Per GIN-17, Guinea is required to comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7), which states that the investigational product (IP) must be coded and labeled in a manner that protects the blinding, if applicable. The IPs must also be suitably packaged in a manner that will prevent contamination and unacceptable deterioration during transport and storage.

Supply, Storage, and Handling Requirements

According to GIN-7, the sponsor must supply the investigator(s)/institution(s) with the investigational products (IPs), including the comparator(s) and placebo, if applicable. The sponsor or the representative (typically the principal investigator (PI)) should not supply either party with the IP(s) until regulatory and ethics approval is obtained.

In addition, GIN-7 specifies that the sponsor must ensure the following:

• Timely delivery of the IP(s)
• Records maintained for IP document shipment, receipt, disposition, return, and destruction
• Written procedures including instructions for handling and storage of the IP(s), adequate and safe receipt of the IP(s), dispensing of the IP(s), retrieval of unused IP(s), return of unused IP(s) to the sponsor, and disposal of unused IP(s) by the sponsor
• IP product quality and stability over the period of use
• Maintain sufficient quantities of the IP(s) to reconfirm specifications, should this become necessary
• IP manufactured according to any applicable Good Manufacturing Practice (GMP)
• Proper coding, packaging, and labeling of the IP(s)
• Acceptable IP handling and storage conditions and shelf-life

Record Requirements

As per GIN-7, the sponsor should inform the investigator(s) and institution(s) in writing of the need for record retention and should notify the investigator(s) and institution(s) in writing when the trial related records are no longer needed. Additionally, the sponsor must ensure sufficient quantities of the IP(s) used in the trial to reconfirm specifications, should this become necessary, and should maintain records of batch sample analyses and characteristics.

All sponsor-specific essential documents should be retained for at least two (2) years after formal discontinuation of the trial or in conformance with applicable regulatory requirements.

The Guinea-PHC and GIN-5 refer to specimens as biological materials.

Import

No information is available regarding specimen imports.

Export

GIN-5 states that the applicant must provide the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) with information on the methods used to export biological materials from Guinea. CNERS must evaluate the proposed methods of conservation and transfer to determine whether they are well described and appropriate.

The Guinea-PHC states that the requirement for consent for research done on biological samples may be waived if it is impossible to locate the donor. However, approval must be granted by the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)).