Guinea
Guinea

Quick facts

Clinical trial application language French
Regulatory authority & ethics committee review may be conducted at the same time No
Clinical trial registration required No
In-country sponsor presence/representation required No
Age of minors Unspecified
Specimens export allowed Unspecified

Regulatory Authority > Regulatory Authority

Last content review/update: March 14, 2023

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.

As set forth in PharmLaw-GIN, the Minister of Health is responsible for authorizing the creation, composition, and operating conditions of the drug marketing authorization committee. The committee advises the Minister to accept, reject, or conduct the scientific evaluation of a drug. During a scientific evaluation, per PharmLaw-GIN, the methods of medical or scientific testing or research are established by decree and the principles of the international charter of human rights and the rules of medical, pharmaceutical, and scientific ethics. See also GIN-22 for additional information on PharmLaw-GIN.

National Directorate of Pharmacy and Medicine (DNPM)

Per GIN-20, DNPM’s responsibilities specifically include the following:

  • Drafting legislation and regulations regarding pharmacy and medicines and ensuring their application
  • Organizing a rational and sustainable supply system for essential drugs for all health structures in Guinea
  • Organizing the quality country of drugs and other health products
  • Organizing and supervising pharmacovigilance to safeguard public health
  • Supervising the activities of pharmaceutical establishments and laboratories
  • Ensuring the application of international conventions on narcotics and psychotropic substances
  • Developing information and continuing education documents for the use of health professionals
  • Participating in the continuing education of pharmacy and medicine practitioners
  • Promoting research, mainly in the field of pharmacy and medicine
  • Promoting the development of the pharmaceutical industry
  • Issuing installation authorizations in the context of the private practice of pharmacy
  • Issuing import and export authorizations for medicines and other health products
  • Issuing import authorizations for narcotics and psychotropics
  • Ensuring the development and implementation of a national plan to combat falsified medicines and the illicit market
  • Validating documentation for the acquisition of drugs and other health products
  • Issuing the marketing authorization for the approval of drugs and other health products
  • Participating in national, sub-regional, regional, and international meetings dealing with pharmacy and drug issues

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

National Ethics Committee for Health Research (CNERS)

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

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

Ministry of Health and Public Hygiene (MSHP)

Per GIN-26 and GIN-27, the following is the MSHP’s contact information:

Ministry of Health and Public Hygiene
Almamya Kaloum
BP 385
Conakry
Republic of Guinea
Telephone: +224 622 54 76 66

National Directorate of Pharmacy and Medicine (DNPM)

Per GIN-2, the following is the DNPM’s contact information:

Direction Nationale de la Pharmacie et du Médicament
Kaloun, Conakry
Republic of Guinea
Telephone: +224 627 00 00 00
Email:
info@dnpm-msgn.com or contact@dnpm-msph.com

National Ethics Committee for Health Research (CNERS)

Per GIN-6 and GIN-21, the following is CNERS’s contact information for submitting applications:

National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé (CNERS))
BlueZone de Dixinn (next to the Kenien bridge on the highway)
Ms. Diallo Aissatou BAH, CNERS Secretary

Phone: (+224) 622 25 31 27 or (+224) 664 57 19 33
Email:
aissatou_dalaba07@yahoo.fr

Contact
Title 1 ((Chapter 1, Article 1) and (Chapter 3, Articles 6, 8, and 11)), and Title 4 (Chapter 2, Articles 96-97)
Chapter I

Regulatory Authority > Scope of Assessment

Last content review/update: January 27, 2023

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 subjects 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 his/her 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

National Ethics Committee for Health Research (CNERS)

Please refer to the Scope of Review section for detailed information on the CNERS clinical trial application review and approval process.

National Directorate of Pharmacy and Medicine (DNPM)

According to GIN-1, the sponsor or his/her 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.)

I, III, and VII
Book Three, Chapter IV
Chapters I and II

Regulatory Authority > Regulatory Fees

Last content review/update: January 27, 2023

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, and which may include fees. Contact the DNPM for more information.

Ethics Committee > Ethics Committee

Last content review/update: August 24, 2022

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 subjects 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 was established in 1998 and 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, the 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 and GIN-13, 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 and 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’ 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, the 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, the 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.

I, II, III, V, VI, VII, VIII (8.2), and XI
Book Three, Chapters I, III, and IV
Chapters I and II

Ethics Committee > Scope of Review

Last content review/update: January 27, 2023

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 his/her 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 his/her 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 DNMP reviews may not be conducted in parallel.

National Ethics Committee for Health Research (CNERS)

GIN-6 indicates that the 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-6 also states that a minimum of three (3) weeks is required between the submission and its review by CNERS. GIN-17 and 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. 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. The 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 on 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

Additionally, 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.

I, III, IV, V, VII, VIII (8.1), and IX (9.1)
Book Three, Chapters I, III, and IV
Chapter I

Ethics Committee > Ethics Committee Fees

Last content review/update: August 24, 2022

National Ethics Committee for Health Research (CNERS)

As per GIN-6, the principal investigator (PI) is responsible for paying a fee of 3,000,000 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 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, he/she will be given an acknowledgement of receipt and a payment receipt.

IV

Ethics Committee > Oversight of Ethics Committees

Last content review/update: January 27, 2023

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.

Chapter I

Clinical Trial Lifecycle > Submission Process

Last content review/update: January 27, 2023

Overview

In accordance with DecreeNoD218, Guinea-PHC, and GIN-5, the principal investigator (PI) must obtain approval to conduct health research involving human subjects 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 his/her 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 his/her representative (typically the PI) should hand deliver one (1) hard copy of the drug import license application to the DNPM’s Division of Pharmaceutical Products.

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 the 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 contact information to submit the CNERS application is as follows:

National Ethics Committee for Research in Health (Comité National d’Ethique pour la Recherche en Santé)
BlueZone de Dixinn (next to the Kenien bridge on the highway)
Ms. Diallo Aissatou BAH, CNERS Secretary

Phone: (+224) 622 25 31 27 or (+224) 664 57 19 33
Email:
aissatou_dalaba07@yahoo.fr

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

I, II, III, V, VI, VII, and VIII (8.2)
Book Three, Chapters I, III, and IV
Chapters I and II

Clinical Trial Lifecycle > Submission Content

Last content review/update: January 27, 2023

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 his/her representative (typically the principal investigator (PI)) along with a request to obtain a drug import license. More detailed information on specific materials to be submitted are not available at this time.

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
  • Informed Consent Form (ICF) and/or assent form
  • Data collection instruments
  • Investigator’s Brochure (IB)
  • Detailed project budget in Guinean francs
  • Profile of investigators in five (5) lines
  • Curriculum Vitae (CVs) of all investigators (four (4) pages maximum by 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 (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 implementing 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
V
6
Book Three, Chapter IV

Clinical Trial Lifecycle > Timeline of Review

Last content review/update: January 27, 2023

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.

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

Ethics Committee Approval

GIN-6 indicates that the principal investigator (PI) is required to submit a research protocol to CNERS. 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-6 also states that a minimum of three (3) weeks is required between the submission and its review by CNERS. GIN-5 and GIN-17 specify 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.) In addition, the file must be submitted at least 15 days before the day of the evaluation session. This period may be exceptionally shortened for health emergency reasons.

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 on 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
V, VI, and VIII (8.2)
Book Three, Chapter IV

Clinical Trial Lifecycle > Initiation, Agreements & Registration

Last content review/update: January 27, 2023

Overview

In accordance with DecreeNoD218, Guinea-PHC, and GIN-5, the principal investigator (PI) must obtain approval to conduct health research involving human subjects 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 his/her 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.

The research should comply with the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7), which Guinea is implementing, per GIN-17.

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 Practices (GCPs), with the applicable regulatory requirement(s), and with 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.

1.25, 4, 5.5, and 5.6
Book Three, Chapter IV
Chapters I and II

Clinical Trial Lifecycle > Safety Reporting

Last content review/update: August 24, 2022

Safety Reporting Definitions

Per the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7), which GIN-17 indicates that Guinea is implementing, the following definitions provide a basis for a common understanding of Guinea’s safety reporting requirements:

  • Adverse Event (AE) – Any untoward medical occurrence in a patient or clinical investigation participant who was administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment
  • Adverse Drug Reaction (ADR) – All noxious and unintended responses to a medicinal product related to any dose
  • Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR) – Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
  • Unexpected Adverse Drug Reaction – An adverse reaction where the nature or severity is inconsistent with the applicable product information

Safety Reporting Requirements

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.

Per GIN-17, each researcher notifies CNERS of AEs/ADRs using his/her own notification form because the CNERS has not yet developed a specific AE/ADR form. No information is currently available regarding a CNERS AE/ADR database.

Ethics Committee Responsibilities

As indicated in GIN-5, the ethics committee (EC) 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, researchers submit completed AE/ADR notification forms to CNERS for review. No further information is available regarding delivery requirements.

VIII (8.2), IX, and XI
1.2, 1.25, 1.50, 1.60, 5.5, and 5.16

Clinical Trial Lifecycle > Progress Reporting

Last content review/update: August 24, 2022

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, as per the International Council for Harmonisation’s Guideline for Good Clinical Practice E6(R2) (GIN-7), which GIN-17 indicates that Guinea is implementing, the investigator should promptly provide written reports to the sponsor and the institutional ethics committee (EC), 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.

VIII (8.2) and IX
4.10 and 4.13

Sponsorship > Definition of Sponsor

Last content review/update: August 24, 2022

Per GIN-17, Guinea is implementing 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.

1.53, 5.1, and 5.2

Sponsorship > Site/Investigator Selection

Last content review/update: August 24, 2022

Overview

Per GIN-17, Guinea is implementing 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 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 currently 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 EC approval
  • The case report forms (CRFs) are designed to capture the required data at all multicenter trial sites
  • Investigator responsibilities are documented prior to the start of the trial
  • All investigators are given instructions on following the protocol, complying with a uniform set of standards to assess clinical and laboratory findings, and completing the CRFs
  • Communication among investigators is facilitated

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.

1.25, 5.2, 5.5, and 5.6

Sponsorship > Insurance & Compensation

Last content review/update: August 24, 2022

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, his/her legal heirs are entitled to financial compensation.

In addition, per GIN-17, Guinea is implementing 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.

4.8 and 5.8
Book Three, Chapters I and III

Sponsorship > Risk & Quality Management

Last content review/update: August 24, 2022

Quality Assurance/Quality Control

Per GIN-17, Guinea is implementing 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.

5.0, 5.1, 5.6, 5.18, 5.19, 5.21, and 6.10

Sponsorship > Data & Records Management

Last content review/update: August 24, 2022

Electronic Data Processing System

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

According to GIN-17, recordkeeping should be conducted in compliance with ICH guidelines. 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.

1.65, 5.5, and 8

Sponsorship > Personal Data Protection

Last content review/update: August 24, 2022

Responsible Parties

For the purposes of data protection requirements, the PDPLaw delineates 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 sponsor (known as the “data controller” in data protection legislation) 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, he/she 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 (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, in the context of complying with data protection requirements, personal data processing is considered legitimate if the data subject expressly gives his/her 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 his/her 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 him/her 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.

Title I (Chapter I) and Title II (Chapters V, VIII, IX, and X)

Informed Consent > Documentation Requirements

Last content review/update: August 24, 2022

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 and/or his/her legal representative(s) or guardian(s). 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 implementing 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 the participant’s legally acceptable representative 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 on 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 and/or the participant’s legal representative(s) or guardian(s) must sign and date the ICF before an independent witness. The Guinea-PHC does not indicate whether the investigator must also sign the ICF.

Per GIN-7, when the participant is illiterate and/or his/her legal representative(s) and/or guardian(s) 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 and his/her legal representative(s) and/or guardian(s)
  • The participant and his/her legal representative(s) and/or guardian(s) 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 his/her legal representative(s) and/or guardian(s) should receive a copy of the signed and dated ICF.

Waiver of Consent

No information is currently available on waiver of consent requirements.

I, IV, V, VII, and IX (9.1)
2, 4.4, 4.8, 8.2, and 8.3
Book Three, Chapters I and IV

Informed Consent > Required Elements

Last content review/update: August 24, 2022

Per GIN-17, Guinea is implementing 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 ICF. As described in GIN-7, both the informed consent discussion and the written informed consent form (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 EC, 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 the participant’s legally acceptable representative 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 the participant’s legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the participant’s willingness to continue participation in the trial
  • 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
4.4 and 4.8

Informed Consent > Participant Rights

Last content review/update: August 24, 2022

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 implementing 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 his/her legal representative(s) or guardian(s) should be informed that participation is voluntary and that he/she 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 and/or his/her legal representative(s) or guardian(s) has/have the right to be informed about the nature and purpose of the research study, study procedures, obligations associated with his/her 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

Information is currently unavailable on this topic.

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 his/her health and welfare must always take precedence over the interests of science and society.

2, 3.1, and 4.8
Book Three, Chapters I, III, and IV

Informed Consent > Emergencies

Last content review/update: August 24, 2022

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 implementing 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 and/or his/her legal representative(s) or guardian(s), 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 and/or his/her legal representative(s) or guardian(s) should be informed about the trial as soon as possible, and consent to continue and other consent should be requested, as appropriate.

Book Three, Chapter I
3.1 and 4.8

Informed Consent > Vulnerable Populations

Last content review/update: August 24, 2022

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 his/her 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 implementing 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.

1.61 and 4.8
Book Three, Chapter I

Informed Consent > Children/Minors

Last content review/update: August 24, 2022

Guinea’s definition of a child/minor is not currently available.

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 legal representative(s) or guardian(s). In the case of disagreement between the wishes of the child and his/her legal representative(s) or guardian(s), the child’s wishes should prevail. The child’s personal consent must be requested when his age allows him to understand the purpose of the research, the risk and disadvantages of this research, and what is expected of his/her 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. The age of consent for children and minors is not defined in the currently available regulatory resources.

Per GIN-17, Guinea is implementing 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 his or her understanding and, if capable, he or she should sign and personally date the written informed consent.

Assent Requirements

No information is currently available on assent requirements.

4.8
Book Three, Chapter I

Informed Consent > Pregnant Women, Fetuses & Neonates

Last content review/update: August 24, 2022

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 implementing 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.

4.8
Book Three, Chapter I

Informed Consent > Prisoners

Last content review/update: August 24, 2022

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.

Book Three, Chapter I

Informed Consent > Mentally Impaired

Last content review/update: August 24, 2022

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, the mentally impaired participant should be fully informed about the study in which he/she has been asked to participate. Informed consent must be obtained from the legal representative(s) or guardian(s) 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 implementing 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 his or her understanding and, if capable, he or she should sign and personally date the written informed consent.

1.61, 3.1, and 4.8
Book Three, Chapter I

Investigational Products > Definition of Investigational Product

Last content review/update: August 24, 2022

Per GIN-17, Guinea is implementing 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.

1.33

Investigational Products > Manufacturing & Import

Last content review/update: January 27, 2023

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 implementing 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 Practices (GMPs) 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 his/her representative (typically the PI) must submit a written request to the DNPM director to obtain approval to import IPs. 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.

Appendix 2
5.0 - Pharmaceutical Regulation
2.12 and 5.13

Investigational Products > Quality Requirements

Last content review/update: August 24, 2022

Investigator’s Brochure

Per GIN-17, Guinea is implementing 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 Documentation

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.

5.13, 5.14, 7, and 8.2

Investigational Products > Labeling

Last content review/update: August 24, 2022

Per GIN-17, Guinea is implementing 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.

5.13

Investigational Products > Product Management

Last content review/update: January 27, 2023

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 his/her representative (typically the principal investigator (PI)) should not supply either party with the IP(s) until he/she obtains regulatory and ethics approval.

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 application of Good Manufacturing Practices (GMPs)
  • 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.

2.12, 4.9, 5.5, 5.12, 5.13, 5.14, and 7

Specimens > Definition of Specimen

Last content review/update: August 24, 2022

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

Book Three, Chapter I
V, VII, and IX

Specimens > Specimen Import & Export

Last content review/update: August 24, 2022

Import

No information is currently 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 and determine whether they are well described and appropriate.

V, VII, and IX

Sources > Requirements

(Legislation) Code of Public Health (Guinea-PHC - French) (GoogleTranslate-Guinea-PHC) (June 19, 1997)
The National Assembly
(Legislation) Law L/2016/037/AN Relating to Cybersecurity and the Protection of Personal Data in the Republic of Guinea (PDPLaw - French) (July 28, 2016)
The National Assembly
(Legislation) Ordinary Law No. L/2018/024/AN Relating to Medicines, Health Products and the Practice of the Pharmacist Profession (PharmLaw-GIN - French) (June 20, 2018)
The National Assembly
(Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNoD218 - French) (October 29, 1998)
National Assembly

Sources > Additional Resources

(Article) Guinea Updates Its Pharmaceutical Regulatory Law (GIN-22) (French) (Date Unavailable)
Promoting the Quality of Medicines (PQM), United States Agency for International Development (USAID)
(DNPM) National Directorate of Pharmacy and Medicine (GIN-2 - French) (Current as of March 14, 2023)
National Directorate of Pharmacy and Medicine
(Document) Evaluation of the Regulation of the Pharmaceutical Sector in Guinea (GIN-8 - French) (2013)
Systems for Improved Access to Pharmaceuticals and Services (SIAPS)
(Document) Nagoya Protocol on Access and Benefit-sharing (GIN-3) (2011)
Convention on Biological Diversity, United Nations
(Document) Republic of Guinea - Pharmaceutical Sector Country Profile Questionnaire (GIN-4 - French) (2011)
Ministry of Health and the World Health Organization
(Document) Standardized Operating Procedure (SOP) for Reviewing a Health Research Protocol (GIN-5 - French) (GoogleTranslate-GIN-5) (Version 6.0) (February 2021)
National Ethics Committee for Research in Health (CNERS)
(International Guidance) Declaration of Helsinki (GIN-23) (October 19, 2013)
World Medical Association
(International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (GIN-7) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(International Guidance) International Ethical Guidelines for Health-Related Research Involving Humans (GIN-24) (2016)
Council for International Organizations of Medical Sciences (CIOMS)
(International Guidance) Operational Guidelines for Ethics Committees that Review Biomedical Research (GIN-25) (2000)
World Health Organization
(Not Available Online) NIAID Communication with Centre National de Formation et de Recherche en Santé Rurale de Maferinyah (December 2022) (GIN-1)
(Not Available Online) NIAID Communication with National Ethics Committee for Research in Health (CNERS) (July 2022) (GIN-17)
(Webpage) About the DNPM (GIN-20) (Current as of March 14, 2023)
National Directorate of Pharmacy and Medicine
(Webpage) Country Profile: Guinea (GIN-10) (Current as of August 24, 2022)
Access and Benefit-sharing Clearing-house, Convention on Biological Diversity, United Nations
(Webpage) Guinea - Contact Information (GIN-27 - French) (Current as of August 24, 2022)
Health Research Web
(Webpage) Ministry of Health and Public Hygiene - Contact Information (GIN-26 - French) (Current as of August 24, 2022)
Go Africa Online
(Webpage) National Ethics Committee for Research in Health (CNERS) - FAQ (GIN-12 - French) (Current as of August 24, 2022)
National Ethics Committee for Research in Health
(Webpage) National Ethics Committee for Research in Health (CNERS) - Submission (GIN-21 - French) (Current as of August 24, 2022)
National Ethics Committee for Research in Health
(Webpage) National Ethics Committee for Research in Health (CNERS) - Who We Are (GIN-13 - French) (Current as of August 24, 2022)
National Ethics Committee for Research in Health

Sources > Forms

(Form) Application Form for the Ethical Evaluation of a Research Project (GIN-6 - French) (GoogleTranslate-GIN-6) (Version 7) (July 2021)
National Ethics Committee for Research in Health (CNERS)
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Announcement

Country Announcement

See the Guinea updates page for details on recent revisions to the profile.

COVID-19 Guidance

  • On March 26, 2020, CNERS issued a communique indicating that CNERS will be utilizing an accelerated review procedure of submitted protocols, including electronic review, in order to facilitate the implementation of research initiatives in Guinea. The accelerated review procedure does not exclude the rigorous application of the fundamental ethical principals intended to protect participants.
  • African regulatory agencies, ethics committees to expedite COVID-19 clinical trial reviews (April 20, 2020)
This message was reviewed on May 5, 2023