Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
Submission Content
Timeline of Review
Trial Initiation
Safety Reporting
Progress Reporting
Sponsorship
Definition of Sponsor
Trial Authorization
Insurance
Compensation
Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
Documentation Requirements
Required Elements
Compensation Disclosure
Participant Rights
Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
Prisoners
Mentally Impaired
Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
Labeling & Packaging
Product Management
Specimens
Definition of Specimen
Import & Export
Consent for Specimens
Guinea
QUICK FACTS
Clinical trial application languageFrench
Parallel regulatory and ethical review permittedYes
Clinical trial registration requiredNo
In-country sponsor presence/representation requiredNo
Age of minorsUnspecified
Specimens export allowedUnspecified
Regulatory Authority > Regulatory Authority
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SUMMARY

Overview
According to DecreeNo D/218 and Additional Resources (A), (B), (C), (D), (E), and (F), the Ministry of Health and Public Hygiene (MOHPH) is the regulatory authority responsible for clinical trial approvals and drug import licensing in the Republic of Guinea. The two branches within the MOHPH directly involved with the clinical trial approval process are as follows:

In addition, according to Additional Resource (G), for all Ebola-related research, the principal investigator (PI) or his/her representative must first obtain protocol approval on the sponsor's behalf from the Ebola Research Commission in Guinea (ERCG) prior to obtaining CNERS’ approval. For detailed information on CNERS’ responsibilities, composition, and procedures, please refer to the Ethics Committee topic.

As per Additional Resource (E), the DNPL is composed of a Drug Division and a Division of Biopharmaceutical Establishments and Laboratories. The Pharmacovigilance, Drugs and Quality Control section within the Drug Division is responsible for issuing import licenses for drug products.

Contact Information
Dr. Kabiné Souare
Ministry of Health and Public Hygiene (Ministère de la Santé Publique) (DNPL)
BP 1490,
Conakry, Guinea

Phone: 224-628-73-38-04
Email: drsouare_kabine@yahoo.fr

ADDITIONAL RESOURCES

(A) (Website) National Ethics Committee for Research in Health – FAQ (French/Français) (Current as of October 29, 2015)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(B) (Document) Standardized Operating Procedure (SOP) for Review of Biomedical Research (French/Français) (Version 2.0) (September 26, 2013)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

Relevant Sections: II and VIII (8.2)

(C) (Form) Ethical Application for Assessment of a Research Project by the CNERS (French/Français) (Date Unavailable)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(D) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(E) (Report) Evaluation of the Regulation of the Pharmaceutical Sector in Guinea (French/Français) (2013)
Systems for Improved Access to Pharmaceuticals and Services (SIAPS), Guinea

Relevant Section: Appendix 2

(F) (Document) Republic of Guinea - Pharmaceutical Sector Country Profile Questionnaire (French/Français) (2011)
Ministry of Health and Public Hygiene and the World Health Organization, Geneva, Switzerland

Relevant Section: 5.0 – Pharmaceutical Regulation

(G) (Document) Procedures for the Submission and Evaluation of Research Projects and Protocols on Ebola Virus Disease (November 12, 2014)
Ebola Research Commission in Guinea, National Coordination for the Fight Against Ebola, Ministry of Health and Public Hygiene, Republic of Guinea

(H) (Website) Directory of Pharmacy and Medicines Directors in Africa (French/Français) (Current as of November 12, 2016)
Network for Medicine and Development (ReMeD), Paris, France

REQUIREMENTS

(1) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French/Français) (October 29, 1998)
Government of the Republic of Guinea

Relevant Sections: Chapters I and II

Regulatory Authority > Scope of Assessment
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SUMMARY

Overview
In accordance with DecreeNo D/218 and Additional Resources (A), (B), (C), (D), (E), and (F), the Ministry of Health and Public Hygiene (MOHPH) is responsible for reviewing, evaluating, and approving clinical trial applications and drug import licenses in the Republic of Guinea. The MOHPH’s two branches include the National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé) (CNERS), which is in charge of the clinical trial application review and approval process for studies conducted in humans, and the National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire) (DNPL), which handles the licensing of drug products for import. According to Additional Resource (D), the CNERS and DNPL reviews may be conducted in parallel.

Clinical Trial Review Process
The MOHPH’s CNERS and DNPL application dossiers each have different requirements.

CNERS
Please refer to the Ethics Committee topic, Scope of Review subtopic for detailed information on the CNERS as well as the Ebola Research Commission in Guinea (ERCG) clinical trial application review and approval process.

DNPL
According to an in-country subject matter expert, the sponsor or his/her designated representative (typically the principal investigator (PI)) is responsible for hand delivering the drug import license application to the DNPL's Pharmacovigilance, Drugs and Quality Control section for review and approval. The DNPL may request drug samples for testing and evaluation unless the PI or the sponsor can provide detailed proof of testing and licensing from regulatory authorities based abroad. Once the DNPL has approved the application, the DNPL will provide the authorization for imported drugs on behalf of the MOHPH.
(See the Clinical Trial Lifecycle topic, Submission Process and Submission Content subtopics for detailed submission requirements.)

ADDITIONAL RESOURCES

(A) (Website) National Ethics Committee for Research in Health – FAQ (French/Français) (Current as of October 29, 2015)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(B) (Document) Standardized Operating Procedure (SOP) for Review of Biomedical Research (French/Français) (Version 2.0) (September 26, 2013)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

Relevant Sections: II and VIII (8.2)

(C) (Form) Ethical Application for Assessment of a Research Project by the CNERS (French/Français) (Date Unavailable)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(D) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(E) (Report) Evaluation of the Regulation of the Pharmaceutical Sector in Guinea (French/Français) (2013)
Systems for Improved Access to Pharmaceuticals and Services (SIAPS), Guinea

Relevant Section: Appendix 2

(F) (Document) Republic of Guinea - Pharmaceutical Sector Country Profile Questionnaire (French/Français) (2011)
Ministry of Health and Public Hygiene and the World Health Organization, Geneva, Switzerland

Relevant Section: 5.0 – Pharmaceutical Regulation

REQUIREMENTS

(1) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French/Français) (October 29, 1998)
Government of the Republic of Guinea

Relevant Sections: Chapters I and II

Regulatory Authority > Regulatory Fees
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SUMMARY

National Ethics Committee for Health Research (Comite National d'Ethique pour la Recherche en Santé) (CNERS) Fee
As per Additional Resource (A), the principal investigator (PI) is responsible for paying a fee to the National Ethics Committee for Health Research (Comite National d'Ethique pour la Recherche en Santé) (CNERS) to submit a clinical trial application for authorization. The CNERS currently requires a non-refundable fee of 3,000,000 Guinean Francs (approximately $400 USD) to submit the application including the protocol for ethics committee (EC) review and approval.

National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire) (DNPL) Fee
No information is currently available regarding taxes and fees associated with submitting a drug import license application to the National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire) (DNPL).

ADDITIONAL RESOURCES

(A) (Form) Ethical Application for Assessment of a Research Project by the CNERS (French/Français (Date Unavailable)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

REQUIREMENTS

No applicable regulatory requirements

Ethics Committee > Ethics Committee
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SUMMARY

Overview
According to the Guinea-PHC, and Additional Resources (A), (B), and (C), Guinea requires the principal investigator (PI) or his/her representative to obtain ethics committee (EC) approval on the sponsor's behalf from the National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé) (CNERS) for each clinical trial. As per DecreeNo D/218 and Additional Resources (A) and (E), the CNERS was established in 1998 and operates under the Ministry of Health and Public Hygiene (MOHPH). According to the Guinea-PHC, and Additional Resources (A), (B), and (E), the CNERS is responsible for reviewing and approving clinical research protocols for studies conducted in humans. However, according to Additional Resource (D) and in-country subject matter experts, institutional ethics committee approval is not required prior to obtaining the CNERS approval.

In addition, according to Additional Resource (F), for all Ebola-related research, the PI must first obtain protocol approval from the Ebola Research Commission in Guinea (ERCG) prior to obtaining the CNERS approval.

CNERS Composition
As specified in DecreeNo D/218 and Additional Resources (A) and (E), the CNERS consists of 17 members appointed by the MOHPH Minister, including an elected coordination office. The coordination office is comprised of a president, a vice president and two (2) secretaries. 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.

As delineated in DecreeNo D/218 and Additional Resources (D) and (E), the 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, 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


According to Additional Resource (B), the committee members should represent a balance between medical and non-medical personnel and gender. The CNERS president is responsible for selecting the members depending on the nature of the proposed research and field of expertise.

CNERS Terms of Reference, Review Procedures and Meeting Schedule
According to DecreeNo D/218, 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 Additional Resource (B) for the SOPs.

As specified in DecreeNo D/218, 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. DecreeNo D/218 specifies that the CNERS committee meets in regular sessions two (2) times a year; additional sessions are convened by the president. Additional Resource (A), however, indicates that the committee meets in regular sessions on the first Thursday of each month; additional sessions are convened by the president. Moreover, Additional Resources (B) and (D) state that the minimum and maximum time limits for the review of a research project following its submission are two (2) weeks and one (1) month respectively.

DecreeNo D/218 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. According to Additional Resource (A), members must receive a copy of the protocol at least six (6) working days prior to the next meeting. Additional Resource (B) indicates that the quorum required for voting is nine (9) members. For detailed CNERS procedures and information on other administrative processes, see DecreeNo D/218, and Additional Resources (A) and (B).

Ebola Research Commission in Guinea (ERCG)
According to Additional Resource (F), as part of Guinea’s national coordination to fight the Ebola virus, the MOHPH has formed the Ebola Research Commission in Guinea (ERCG). The ERCG requires the PI or his/her representative to obtain its approval on the sponsor's behalf for all research protocols studying the Ebola Virus Disease in Guinea.

ADDITIONAL RESOURCES

(A) (Website) National Ethics Committee for Research in Health – FAQ (French/Français) (Current as of October 29, 2015)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(B) (Document) Standardized Operating Procedure (SOP) for Review of Biomedical Research (French/Français) (Version 2.0) (September 26, 2013)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

Relevant Sections: II and VIII (8.2)

(C) (Form) Ethical Application for Assessment of a Research Project by the CNERS (French/Français) (Date Unavailable)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(D) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(E) (Brochure) CNERS - National Ethics Committee for Research in Health (Guinea) (French/Français) (Date Unavailable)
National Ethics Committee for Research in Health (CNERS), Conakry, Guinea

Relevant Sections: Creation, Mission/Powers, and Organization/Functions

(F) (Document) Procedures for the Submission and Evaluation of Research Projects and Protocols on Ebola Virus Disease (November, 12 2014)
Ebola Research Commission in Guinea, National Coordination for the Fight Against Ebola, Ministry of Health and Public Hygiene, Republic of Guinea

REQUIREMENTS

(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French/Français) (June 19, 1997)
National Assembly of the Republic of Guinea, Republic of Guinea

Relevant Section: Book Three, Chapter IV

(2) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French/Français) (October 29, 1998)
Government of the Republic of Guinea

Relevant Sections: Chapters I and II

Ethics Committee > Scope of Review
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SUMMARY

Overview
According to DecreeNo D/218, the Guinea-PHC, and Additional Resources (A) and (B), 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 Additional Resource (B), 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.

As per the Guinea-PHC and Additional Resource (B), the CNERS must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable.

DecreeNo D/218, the Guinea-PHC, and Additional Resources (A) and (B) also state that the 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 Additional Resource (B) for detailed ethical review guidelines.

Role in Clinical Trial Approval Process
According to the Guinea-PHC and Additional Resources (A) and (B), the CNERS must approve a clinical trial application and the protocol and the  National Directorate of Pharmacy and Laboratory (Direction National de la Pharmacie et du Laboratoire (DNPL)) must issue a drug import license prior to the sponsor or his/her representative initiating the clinical trial.

As per the Guinea-PHC and Additional Resources (A), (B), (C) and (D), the principal investigator (PI) or his/her representative is responsible for submitting an application on the sponsor's behalf to the CNERS for review and approval.

CNERS
As stated in the Guinea-PHC, the PI is required to submit a research proposal to the CNERS at least 90 days prior to the date set for the study’s commencement. In addition, according to Additional Resource (A), PIs are required to submit protocols to be reviewed at least six (6) working days prior to the CNERS committee meeting. Additional Resource (D) also indicates that protocols should be submitted at least one (1) week before the review session.

Per the Guinea-PHC, the CNERS must give its opinion on any research proposal submitted within a period not exceeding 60 days from the project’s filing date. Moreover, Additional Resource (A) states that the CNERS committee notifies the PI in writing within 10 days of the committee’s session. Additional Resource (D), however, indicates that if the application is complete, an approval letter can be expected in one (1) to two (2) weeks. As per Additional Resource (A), a committee approval is valid for one (1) year, and renewable upon request by the PI.

Ebola Research Commission in Guinea (ERCG)
ERCG approval is required for all Ebola Virus Disease studies before the protocol will be reviewed by the CNERS. As delineated in Additional Resource (E), the following documentation must be submitted to the ERCG:

  • Protocol (in electronic format; hard copies are acceptable)
  • Cover letter (one (1) copy) including contact information for PI(s) or person responsible for the study
  • Protocol synopsis (summary in French)
  • Complete Protocol (in French or English)
  • Investigator’s Brochure
  • Informed Consent Form (in French and to be translated to the local languages for administrative purposes)
  • Investigators list (attached abstracts/summaries of CVs)
  • Data collection tools
  • Study budget

See Additional Resource (E) for detailed format requirements.

The ERCG will give their opinion within a minimum of two (2) weeks, not to exceed one (1) month. In exceptional circumstances, the review period may be reduced to one (1) week. Once the opinion of the ERCG is obtained, the protocol is transferred to CNERS for approval.

ADDITIONAL RESOURCES

(A) (Website) National Ethics Committee for Research in Health – FAQ (French/Français) (Current as of October 29, 2015)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(B) (Document) Standardized Operating Procedure (SOP) for Review of Biomedical Research (French/Français) (September 26, 2013)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

Relevant Sections: II, III, IV, V, VI, VII (7.1), and VIII (8.2)

(C) (Form) Ethical Application for Assessment of a Research Project by the CNERS (French/Français) (Date Unavailable)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(D) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(E) (Document) Procedures for the Submission and Evaluation of Research Projects and Protocols on Ebola Virus Disease (November 12, 2014)
Ebola Research Commission in Guinea, National Coordination for the Fight Against Ebola, Ministry of Health and Public Hygiene, Republic of Guinea

REQUIREMENTS

(1) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French/Français) (October 29, 1998)
Government of the Republic of Guinea

Relevant Section: Chapter I

(2) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French/Français) (June 19, 1997)
National Assembly of the Republic of Guinea, Republic of Guinea

Relevant Sections: Book Three, Chapters I, III, and IV

Ethics Committee > Ethics Committee Fees
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SUMMARY

Overview
According to Additional Resource (A), the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé) (CNERS) requires the principal investigator (PI) to pay a non-refundable fee of 3,000,000 Guinean Francs (approximately $400 USD) to submit a protocol for ethics committee (EC) review and approval.

ADDITIONAL RESOURCES

(A) (Form) Ethical Application for Assessment of a Research Project by the CNERS (French/Français) (Date Unavailable)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

REQUIREMENTS

No applicable regulatory requirements

Ethics Committee > Authorizing Body
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SUMMARY

Overview
As stated in the Ethics Committee subtopic, per DecreeNo D/218 and Additional Resource (A), the Ministry of Health and Public Hygiene (MOHPH) is the authorizing body of the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé) (CNERS). The 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 Additional Resource (B), the CNERS is accredited by the MOHPH.

ADDITIONAL RESOURCES

(A) (Website) National Ethics Committee for Research in Health – FAQ (French/Français) (Current as of October 29, 2015)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(B) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(C) (Form) Ethical Application for Assessment of a Research Project by the CNERS (French/Français) (Date Unavailable)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

REQUIREMENTS

(1) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French/Français) (October 29, 1998)
Government of the Republic of Guinea

Relevant Section: Chapter I

Clinical Trial Lifecycle > Submission Process
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SUMMARY

Overview
According to DecreeNo D/218, Additional Resources (A), (B), (C), (D), (E), (F), and (G), and in-country subject matter experts, Guinea requires the principal investigator (PI) or his/her designated representative to obtain clinical trial authorization on the sponsor’s behalf from the Ministry of Health and Public Hygiene (MOHPH). In addition, the sponsor or his/her designated representative (typically the PI) is responsible for obtaining the MOHPH’s approval to import study drugs. As per Additional Resources (A), (B), (C), (D), (E), and (F), the MOHPH’s two branches include the National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé) (CNERS), which is in charge of the clinical trial application review and approval process for studies conducted in humans, and the National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire) (DNPL), which handles the licensing of drug products for import. According to Additional Resource (D) and an in-country subject matter expert, the CNERS and the DNPL may conduct their reviews in parallel. However, per Additional Resources (A), (D), and (G), and in-country subject matter experts, the clinical trial authorization will only be finalized once both the CNERS approval and the drug import license are obtained. (See Submission Content  subtopic for detailed submission requirements).

In addition, as per Additional Resource (H), for all Ebola-related research, the PI or his/her representative must first obtain protocol approval on the sponsor’s behalf from the Ebola Research Commission in Guinea (ERCG) before obtaining the CNERS approval. Please refer to the Ethics Committee topic for more information regarding the CNERS and the ERCG requirements.

Delivery Address for Clinical Trial Applications
According to Additional Resource (C) and in-country subject matter experts, the contact information for the CNERS and the DNPL is as follows:

CNERS
Miss Aissatou Sanoussy BAH
Comité National d'Ethique pour la Recherche en Santé
BP 634
Conakry, Guinea

Phone: (224) 669 930 951
Fax: Not available
Email: aichabahsanoussy88@yahoo.fr

*ERCG applications are also submitted to the CNERS address.

DNPL
Dr. Kabiné Souare
Ministry of Health and Public Hygiene (Ministère de la Santé Publique) (DNPL)
BP 1490,
Conakry, Guinea

Phone: (224) 45 20 28
Fax: (224) 45 20 50
Email: drsouare_kabine@yahoo.fr

Assembly and Number of Copies
According to Additional Resources (C), and (D), a cover letter and ten (10) copies of the clinical trial application should be submitted to the CNERS. As per Additional Resource (A), the CNERS submission form is available at its headquarters at Ignace Deen Hospital. However, an in-country subject matter expert has also indicated that the CNERS application forms are available electronically and will be sent, upon request, by email. The protocol must be submitted in hard copy only.  

According to Additional Resource (D), one (1) hard copy of the drug import license application should be submitted to the DNPL. The DNPL application forms are only available in paper form from the DNPL's Pharmacovigilance, Drugs and Quality Control section.

Clinical Trial Application Language Requirements
According to Additional Resources (C) and (D), the clinical trial application and accompanying materials including the DNPL drug import license application must be provided in French. Per Additional Resource (H), the clinical protocol portion of the application may be submitted in French or in English.

ADDITIONAL RESOURCES

(A) (Website) National Ethics Committee for Research in Health – FAQ (French/Français) (Current as of October 29, 2015)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(B) (Document) Standardized Operating Procedure (SOP) for Review of Biomedical Research (French/Français) (Version 2.0) (September 26, 2013)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

Relevant Sections: II and VIII (8.2)

(C) (Form) Ethical Application for Assessment of a Research Project by the CNERS (French/Français) (Date Unavailable)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(D) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(E) (Brochure) CNERS - National Ethics Committee for Research in Health (Guinea) (French/Français) (Date Unavailable)
National Ethics Committee for Research in Health (CNERS), Conakry, Guinea

Relevant Sections: Creation, Mission/Powers, and Organization/Functions

(F) (Report) Evaluation of the Regulation of the Pharmaceutical Sector in Guinea (French/Français) (2013)
Systems for Improved Access to Pharmaceuticals and Services (SIAPS), Guinea

Relevant Section: Appendix 2

(G) (Document) Republic of Guinea - Pharmaceutical Sector Country Profile Questionnaire (French/Français) (2011)
Ministry of Health and Public Hygiene and the World Health Organization, Geneva, Switzerland

Relevant Section: 5.0 – Pharmaceutical Regulation

(H) (Document) Procedures for the Submission and Evaluation of Research Projects and Protocols on Ebola Virus Disease (November 12, 2014)
Ebola Research Commission in Guinea, National Coordination for the Fight Against Ebola, Ministry of Health and Public Hygiene, Republic of Guinea

(I) (Website) Directory of Pharmacy and Medicines Directors in Africa (French/Français) (Current as of November 12, 2016)
Network for Medicine and Development (Réseau Médicaments et Développement) (ReMeD), Paris, France

REQUIREMENTS

(1) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French/Français) (October 29, 1998)
Government of the Republic of Guinea

Relevant Sections: Chapters I and II



Clinical Trial Lifecycle > Submission Content
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SUMMARY

Overview
In accordance with DecreeNo D/218, the Guinea-PHC, Additional Resources (A), (B), (C), (D), (E), (F), and (G), and in-country subject matter experts, Guinea requires  the principal investigator (PI) or his/her designated representative to obtain clinical trial authorization on the sponsor’s behalf from the Ministry of Health and Public Hygiene‘s (MOHPH) National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé) (CNERS). In addition, the sponsor or his/her representative (typically the PI) is responsible for obtaining the MOHPH’s approval to import study drugs from the National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire) (DNPL) prior to initiating a study.

CNERS Requirements
According to Additional Resources (B), (C), and (D), the CNERS requires a cover letter and ten (10) copies of each of the documents listed below, unless otherwise indicated:

  • Cover letter (one (1) copy)
  • Project summary
  • Clinical trial application form
  • Protocol
  • Investigator’s Brochure (IB)
  • Informed Consent Form (ICF)
  • Case Report Form and other applicable data collection instruments
  • Investigators’ Curriculum Vitaes (CVs)
  • Project budget
  • Previous related decisions from the CNERS and/or associated partners


DNPL Requirements
As per Additional Resource (D) and an in-country subject matter expert, an electronic copy of application form is available from the DNPL upon request. However, detailed information on accompanying materials to be included with the DNPL application are not available at this time.  

Ebola Research Commission in Guinea (ERCG) Requirements
As per Additional Resource (H), for all Ebola-related research, the Ebola Research Commission in Guinea (ERCG) must review and approve the clinical trial application prior to obtaining the CNERS approval. Below is a list of required ERCG documentation:

  • Cover letter (one (1) copy) including contact information for PI(s) or person responsible for the study
  • Protocol synopsis (summary in French)
  • Complete protocol (in French or English)
  • IB
  • ICF (in French and to be translated to the local languages for administrative purposes)
  • Investigators list (attached abstracts/summaries of CVs)
  • Data collection tools
  • Study budget

See Additional Resource (H) for detailed submission requirements.

CNERS/ERCG Clinical Protocol
As indicated in the Guinea-PHC and Additional Resource (H), the CNERS/ERCG clinical protocol should contain the following elements:

  • Background
  • Identity of the sponsor and investigator
  • Study rationale
  • Objectives
  • Methodology
  • Study duration and progress
  • Data collection
  • Statistical analysis
  • Ethical aspects
  • Expected results
  • Detailed budget
  • References
ADDITIONAL RESOURCES

(A) (Website) National Ethics Committee for Research in Health – FAQ (French/Français) (Current as of October 29, 2015)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(B) (Document) Standardized Operating Procedure (SOP) for Review of Biomedical Research (French/Français) (Version 2.0) (September 26, 2013)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

Relevant Sections: II and VIII (8.2)

(C) (Form) Ethical Application for Assessment of a Research Project by the CNERS (French/Français) (Date Unavailable)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(D) (Document) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(E) (Brochure) CNERS - National Ethics Committee for Research in Health (Guinea) (French/Français) (Date Unavailable)
National Ethics Committee for Research in Health (CNERS), Conakry, Guinea

Relevant Sections: Creation, Mission/Powers, and Organization/Functions

(F) (Report) Evaluation of the Regulation of the Pharmaceutical Sector in Guinea (French/Français) (2013)
Systems for Improved Access to Pharmaceuticals and Services (SIAPS), Guinea

Relevant Section: Appendix 2

(G) (Document) Republic of Guinea - Pharmaceutical Sector Country Profile Questionnaire (French/Français) (2011)
Ministry of Health and Public Hygiene and the World Health Organization, Geneva, Switzerland

Relevant Section: 5.0 – Pharmaceutical Regulation

(H) (Document) Procedures for the Submission and Evaluation of Research Projects and Protocols on Ebola Virus Disease (November 12, 2014)
Ebola Research Commission in Guinea, National Coordination for the Fight Against Ebola, Ministry of Health and Public Hygiene, Republic of Guinea

REQUIREMENTS

(1) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French/Français) (October 29, 1998)
Government of the Republic of Guinea

Relevant Sections: Chapters I and II

 

(2) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French/Français) (June 19, 1997)
National Assembly of the Republic of Guinea, Republic of Guinea

Relevant Section: Book Three, Chapter IV

Clinical Trial Lifecycle > Timeline of Review
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SUMMARY

Overview
According to DecreeNo D/218, the Guinea-PHC, and Additional Resources (A), (B), (C), (D), (E), (F), and (G), the Ministry of Health and Public Hygiene (MOHPH)’s National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé) (CNERS) must approve the clinical trial application and the MOHPH’s National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire) (DNPL) must issue a drug import license prior to the sponsor or his/her representative initiating the clinical trial. According to Additional Resource (D), the CNERS and the DNPL may conduct their reviews in parallel. However, per Additional Resources (A), (D), and (G), and in-country subject matter experts, the clinical trial authorization will only be finalized once both the CNERS approval and the drug import license are obtained. (See Submission Content subtopic for detailed submission requirements).

Ebola Research Commission in Guinea (ERCG)
Approval
No information is currently available on the timeline for approval of the ERCG.

MOHPH Approval
CNERS Clinical Trial Application
Per the Guinea-PHC, the CNERS must give its opinion on any research proposal submitted within a period not exceeding 60 days from the project’s filing date. Moreover, according to Additional Resource (A), the CNERS committee notifies the principal investigator (PI) in writing within ten (10) days of the committee’s session. Additional Resource (D), however, indicates that if the application is complete, an approval letter can be expected in one (1) to two (2) weeks. As indicated in Additional Resource (A), committee approval is valid for one (1) year, and it is renewable upon request by the PI.

As stated in the Guinea-PHC, the PI is required to submit a research proposal to the CNERS at least 90 days prior to the date set for the study’s commencement. In addition, according to Additional Resource (A), the PI or his/her representative is required to submit the application on the sponsor’s behalf to be reviewed at least six (6) working days prior to the CNERS committee meeting. Additional Resource (D) also indicates that the application should be submitted at least one (1) week before the review session.

DNPL Import License Application
According to Additional Resource (D), the DNPL’s approval of a drug import license application typically takes two (2) weeks, or, about one (1) month when the customs processing phase is included.

According to Additional Resource (D) and an in-country subject matter expert, the PI or his/her representative should hand deliver the drug import license application on the sponsor’s behalf to the DNPL’s Division of Pharmaceutical Products.

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

Institutional EC Approval
According to Additional Resource (D) and in-country subject matter experts, institutional ethics committee approval is not required prior to obtaining the CNERS approval.

ADDITIONAL RESOURCES

(A) (Website) National Ethics Committee for Research in Health – FAQ (French/Français) (Current as of October 29, 2015)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(B) (Document) Standardized Operating Procedure (SOP) for Review of Biomedical Research (French/Français) (Version 2.0) (September 26, 2013)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

Relevant Sections: II and VIII (8.2)

(C) (Form) Ethical Application for Assessment of a Research Project by the CNERS (French/Français) (Date Unavailable)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(D) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(E) (Brochure) CNERS - National Ethics Committee for Research in Health (Guinea) (French/Français) (Date Unavailable)
National Ethics Committee for Research in Health (CNERS), Conakry, Guinea

Relevant Sections: Creation, Mission/Powers, and Organization/Functions

(F) (Report) Evaluation of the Regulation of the Pharmaceutical Sector in Guinea (French/Français) (2013)
Systems for Improved Access to Pharmaceuticals and Services (SIAPS), Guinea

Relevant Section: Appendix 2

(G) (Document) Republic of Guinea - Pharmaceutical Sector Country Profile Questionnaire (French/Français) (2011)
Ministry of Health and Public Hygiene and the World Health Organization, Geneva, Switzerland

Relevant Section: 5.0 – Pharmaceutical Regulation

REQUIREMENTS

(1) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French/Français) (October 29, 1998)
Government of the Republic of Guinea

Relevant Sections: Chapters I and II

(2) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French/Français) (June 19, 1997)
National Assembly of the Republic of Guinea, Republic of Guinea

Relevant Section: Book Three, Chapter IV

Clinical Trial Lifecycle > Trial Initiation
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SUMMARY

Overview
In accordance with DecreeNo D/218, the Guinea-PHC, Additional Resources (A), (B), (C), (D), (E), (F), and (G), and in-country subject matter experts, a clinical trial can only commence after the sponsor or his/her representative obtains approval from the Ministry of Health and Public Hygiene (MOHPH)’s National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé) (CNERS) and the National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire) (DNPL) for both the clinical trial and drug import license applications respectively. As per Additional Resources (C) and (D), and an in-country subject matter expert, the principal investigator (PI) or his/her designated representative will submit the CNERS clinical trial application on the sponsor’s behalf, and the sponsor or his/her representative (typically the PI) will submit the DNPL drug import license application. Additional Resource (D) and an in-country subject matter expert also state that the CNERS and the DNPL may conduct their reviews in parallel. However, per Additional Resources (A), (D), and (G), and in-country subject matter experts, the clinical trial authorization will only be finalized once both the CNERS approval and the drug import license are obtained. No waiting period is required following the sponsor’s receipt of these approvals.

Clinical Trial Agreement
No information is available at this time on clinical trial agreement requirements.

Ethics Committee (EC) Confirmation of Review and Approval
In accordance with DecreeNo D/218, the Guinea-PHC, and Additional Resources (A), (B), (C), (D), and (E), a clinical trial can only commence after the sponsor or his/her representative obtains ethical approval from the MOHPH’s CNERS (in addition to drug import approval from MOHPH’s DNPL). In addition, per Additional Resource (H), for all Ebola-related research, the Ebola Research Commission in Guinea (ERCG) must approve these protocols prior to obtaining CNERS approval. (See Ethics Committee topic, Ethics Committee and Scope of Review subtopics, and Clinical Trial Lifecycle topic, Submission Content subtopic for additional details on the EC review process and for more information on ERCG requirements).

Clinical Trial Registry
According to Additional Resource (D), the MOHPH does not currently require the PI or the sponsor or his/her representative to register with either a domestic or international clinical trial registry.

Data and Safety Monitoring Board (DSMB)
As per Additional Resource (D), the MOHPH does not require the sponsor or his/her representative to establish a Data Safety Monitoring Board (DSMB).

ADDITIONAL RESOURCES

(A) (Website) National Ethics Committee for Research in Health – FAQ (French/Français) (Current as of October 29, 2015)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(B) (Document) Standardized Operating Procedure (SOP) for Review of Biomedical Research (French/Français) (Version 2.0) (September 26, 2013)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

Relevant Sections: II and VIII (8.2)

(C) (Form) Ethical Application for Assessment of a Research Project by the CNERS (French/Français) (Date Unavailable)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(D) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(E) (Brochure) CNERS - National Ethics Committee for Research in Health (Guinea) (French/Français) (Date Unavailable)
National Ethics Committee for Research in Health (CNERS), Conakry, Guinea

Relevant Sections: Creation, Mission/Powers, and Organization/Functions

(F) (Report) Evaluation of the Regulation of the Pharmaceutical Sector in Guinea (French/Français) (2013)
Systems for Improved Access to Pharmaceuticals and Services (SIAPS), Guinea

Relevant Section: Appendix 2

(G) (Document) Republic of Guinea - Pharmaceutical Sector Country Profile Questionnaire (French/Français) (2011)
Ministry of Health and Public Hygiene and the World Health Organization, Geneva, Switzerland

Relevant Section: 5.0 – Pharmaceutical Regulation

(H) (Document) Procedures for the Submission and Evaluation of Research Projects and Protocols on Ebola Virus Disease (November 12, 2014)
Ebola Research Commission in Guinea, National Coordination for the Fight Against Ebola, Ministry of Health and Public Hygiene, Republic of Guinea

REQUIREMENTS

(1) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French/Français) (October 29, 1998)
Government of the Republic of Guinea

Relevant Sections: Chapters I and II

(2) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French/Français) (June 19, 1997)
National Assembly of the Republic of Guinea, Republic of Guinea

Relevant Section: Book Three, Chapter IV

Clinical Trial Lifecycle > Safety Reporting
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SUMMARY

Overview
According to Additional Resource (A), all serious and unexpected adverse events (AEs)/adverse drug reactions (ADRs) must be reported to the Ministry of Health and Public Hygiene (MOHPH)’s National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé) (CNERS) for review.

Additional Resource (B) indicates that Guinea has not yet developed any formal pharmacovigilance regulations or guidelines of its own. However, an unspecified official AE/ADR reporting form is being used in Guinea, and this reported information is stored in a national AE/ADR database. No further information is available regarding either the form or the database at this time.

Also, based on Additional Resource (C), and an in-country subject matter expert, Guinea does comply with the World Health Organization's (WHO) pharmacovigilance guidelines. For detailed AE/ADR reporting requirements and form completion, see Additional Resources (D) and (E).

Data and Safety Monitoring Board
As per Additional Resource (C), the MOHPH does not require the sponsor or his/her representative to establish a Data Safety Monitoring Board (DSMB).

ADDITIONAL RESOURCES

(A) (Document) ) Standardized Operating Procedure (SOP) for Review of Biomedical Research (French/Français) (Version 2.0) (September 26, 2013)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

Relevant Sections: VII (7.2) and VIII (8.3)

(B) (Document) Republic of Guinea - Pharmaceutical Sector Country Profile Questionnaire (French/Français) (2011)
Ministry of Health and Public Hygiene and the World Health Organization, Geneva, Switzerland

Relevant Section: 5.0 – Pharmaceutical Regulation

(C) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(D) (WHO Guidance) Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre (English and French/Français) (2000)
World Health Organization, Geneva, Switzerland

(E) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (Annex 3) (WHO Technical Report Series, No. 850) (English) (1995)
World Health Organization, Geneva, Switzerland

Relevant Section: 8

REQUIREMENTS

No applicable regulatory requirements

Clinical Trial Lifecycle > Progress Reporting
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SUMMARY

Overview
According to Additional Resources (A) and (B), and an in-country subject matter expert, the principal investigator (PI) and the sponsor share responsibility for submitting an annual progress report on the status of a clinical trial and for submitting a final study report upon the trial’s completion.

No additional information is available at this time.

ADDITIONAL RESOURCES

(A) (Document) Standardized Operating Procedure (SOP) for Review of Biomedical Research (French/Français) (Version 2.0) (September 26, 2013)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

Relevant Sections: VII (7.3) and VIII (8.3.8)

(B) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

REQUIREMENTS

No applicable regulatory requirements

Sponsorship > Definition of Sponsor
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SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Sponsorship > Trial Authorization
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SUMMARY

Overview
In accordance with DecreeNo D/218, the Guinea-PHC, Additional Resources (A), (B), (C), (D), (E), (F), and (G), and in-country subject matter experts, Guinea requires the principal investigator (PI) or his/her designated representative to submit a clinical trial application on the sponsor’s behalf to the Ministry of Health and Public Hygiene (MOHPH)’s National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé) (CNERS) to obtain approval to conduct a study. In addition, the sponsor or his/her designated representative (typically the PI) is responsible for submitting a drug import application to the MOHPH’s National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire) (DNPL) to obtain approval to import study drugs.

According to Additional Resource (D) and an in-country subject matter expert, the CNERS and the DNPL may conduct their reviews in parallel. However, per Additional Resources (A), (D), (G), and in-country subject matter experts, the clinical trial authorization will only be finalized once both the CNERS and DNPL approvals are obtained.

In addition to the completed application, the sponsor must also provide the clinical protocol, the informed consent form, the Investigator’s Brochure, and other documentation covered in the Clinical Trial Lifecycle topic, Submission Content subtopic.

Ebola Research Commission in Guinea (ERCG)
As per Additional Resource (H), for all Ebola-related research, the PI or his/her designated representative must first obtain protocol approval on the sponsor’s behalf from the Ebola Research Commission in Guinea (ERCG) before obtaining the CNERS approval to conduct a clinical trial. Please refer to the Ethics Committee topic and Clinical Trial Lifecycle topic, Submission Content subtopic, for more information regarding ERCG and additional documentation requirements.

ADDITIONAL RESOURCES

(A) (Website) National Ethics Committee for Research in Health – FAQ (French/Français) (Current as of October 29, 2015)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(B) (Document) Standardized Operating Procedure (SOP) for Review of Biomedical Research (French/Français) (Version 2.0) (September 26, 2013)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

Relevant Sections: II and VIII (8.2)

(C) (Form) Ethical Application for Assessment of a Research Project by the CNERS (French/Français) (Date Unavailable)
National Ethics Committee for Research in Health (CNERS), Conakry, Republic of Guinea

(D) (Document) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(E) (Brochure) CNERS - National Ethics Committee for Research in Health (Guinea) (French/Français) (Date Unavailable)
National Ethics Committee for Research in Health (CNERS), Conakry, Guinea

Relevant Sections: Creation, Mission/Powers, and Organization/Functions

(F) (Report) Evaluation of the Regulation of the Pharmaceutical Sector in Guinea (French/Français) (2013)
Systems for Improved Access to Pharmaceuticals and Services (SIAPS), Guinea

Relevant Section: Appendix 2

(G) (Document) Republic of Guinea - Pharmaceutical Sector Country Profile Questionnaire (French/Français) (2011)
Ministry of Health and Public Hygiene and the World Health Organization, Geneva, Switzerland

Relevant Section: 5.0 – Pharmaceutical Regulation

(H) (Document) Procedures for the Submission and Evaluation of Research Projects and Protocols on Ebola Virus Disease (November 12, 2014)
Ebola Research Commission in Guinea, National Coordination for the Fight Against Ebola, Ministry of Health and Public Hygiene, Republic of Guinea

REQUIREMENTS

(1) (Regulation) Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS) (DecreeNo D/218 - French/Français) (October 29, 1998)
Government of the Republic of Guinea

Relevant Sections: Chapters I and II

(2) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French/Français) (June 19, 1997)
National Assembly of the Republic of Guinea, Republic of Guinea

Relevant Section: Book Three, Chapter IV

Sponsorship > Insurance
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SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Sponsorship > Compensation
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SUMMARY

Overview
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.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French/Français) (June 19, 1997)
National Assembly of the Republic of Guinea, Republic of Guinea

Relevant Section: Book Three, Chapters I and III

Sponsorship > Quality, Data & Records Management
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SUMMARY

Overview
No relevant regulatory provisions are currently available regarding the sponsor’s role in implementing premature study termination/suspension measures, maintaining quality assurance and quality control systems including audit procedures or electronic data processing systems, or running a multicenter study.

Record Management
According to Additional Resource (A) and an in-country subject matter expert, recordkeeping should be conducted in compliance with the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products and the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs). For detailed recordkeeping information, please refer to section 8 of the WHO-GCPs and Section 5.5 of the ICH-GCPs.

ADDITIONAL RESOURCES

(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(B) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (Annex 3) (WHO Technical Report Series, No. 850) (1995)
World Health Organization, Geneva, Switzerland

Relevant Section: 8

(C) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Section: 5.5

REQUIREMENTS

No applicable regulatory requirements

Sponsorship > Site/Investigator Selection
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SUMMARY

Overview
No information is currently available regarding the sponsor’s role in selecting the investigator(s) and institution(s) for the clinical trial, or his/her responsibility to establish agreement(s) with the investigator(s) and institution(s) prior to conducting a study.

Foreign Sponsor Responsibilities
No information is currently available regarding foreign sponsor regulatory requirements.

Data and Safety Monitoring Board
As per Additional Resource (A), the Ministry of Health and Public Hygiene (MOHPH) does not require the sponsor or his/her representative to establish a Data Safety Monitoring Board (DSMB).

ADDITIONAL RESOURCES

(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

REQUIREMENTS

No applicable regulatory requirements

Informed Consent > Documentation Requirements
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SUMMARY

Overview
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 Additional Resource (A), the  informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by the National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé) (CNERS) with the clinical trial application. (See the Informed Consent topic, Required Elements subtopic 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.

Language Requirements
According to Additional Resource (A), the ICF must be written in French and in the vernacular language of the research participant.

Documentation Copies
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 Additional Resource (B) and in-country subject matter experts, clinical trials must comply with informed consent requirements in the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) and the World Health Organization’s good clinical practice guidelines (WHO-GCPs).

ADDITIONAL RESOURCES

(A) (Document) Procedures for the Submission and Evaluation of Research Projects and Protocols on Ebola Virus Disease (November 12, 2014)
Ebola Research Commission in Guinea, National Coordination for the Fight Against Ebola, Ministry of Health and Public Hygiene, Republic of Guinea

(B) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(C) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996) International Conference on Harmonisation, Geneva, Switzerland

Relevant Section: 4.8

(D) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995) World Health Organization, Geneva, Switzerland

Relevant Section: 8

REQUIREMENTS

(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French/Français) (June 19, 1997)
National Assembly of the Republic of Guinea, Republic of Guinea

Relevant Sections: Book Three, Chapters I and IV

Informed Consent > Required Elements
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SUMMARY

Overview
According to Additional Resource (A), prior to beginning a clinical trial, the principal investigator (PI) is required to obtain ethics committee (EC) approval from the National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé) (CNERS) for the written informed consent form (ICF).

No information is currently available on the specific elements required to be included in the ICF.

No Coercion
As per the Guinea-PHC, a participant should not be coerced or pressured in any way during the consent process.

Per Additional Resource (B) and in-country subject matter experts, clinical trials must comply with informed consent requirements in the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) and the World Health Organization’s good clinical practice guidelines (WHO-GCPs).

ADDITIONAL RESOURCES

(A) (Document) Procedures for the Submission and Evaluation of Research Projects and Protocols on Ebola Virus Disease (November 12, 2014)
Ebola Research Commission in Guinea, National Coordination for the Fight Against Ebola, Ministry of Health and Public Hygiene, Republic of Guinea

(B) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(C) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996) International Conference on Harmonisation, Geneva, Switzerland

Relevant Section: 4.8

(D) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995) World Health Organization, Geneva, Switzerland

Relevant Section: 8

REQUIREMENTS

(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French/Français) (June 19, 1997)
National Assembly of the Republic of Guinea, Republic of Guinea

Relevant Section: Book Three, Chapter I

Informed Consent > Compensation Disclosure
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SUMMARY

Overview
Guinea does not have any specified requirements regarding what compensation details must be presented to the potential research participant during the informed consent process.   

Per Additional Resource (A) and in-country subject matter experts, clinical trials must comply with informed consent requirements in the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) and the World Health Organization’s good clinical practice guidelines (WHO-GCPs).

ADDITIONAL RESOURCES

(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(B) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996) International Conference on Harmonisation, Geneva, Switzerland

Relevant Section: 4.8

(C) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995) World Health Organization, Geneva, Switzerland

Relevant Section: 8

REQUIREMENTS

(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French/Français) (June 19, 1997)
National Assembly of the Republic of Guinea, Republic of Guinea

Relevant Sections: Book Three, Chapters I and III

Informed Consent > Participant Rights
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SUMMARY

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.

The Right to Participate, Abstain, or Withdraw
As set forth in the Guinea-PHC, a potential research participant or his/her legal representative(s) or guardian(s) should be informed that participation is voluntary, 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, 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, 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 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.

Per Additional Resource (A) and in-country subject matter experts, clinical trials must comply with informed consent requirements in the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) and the World Health Organization’s good clinical practice guidelines (WHO-GCPs).

ADDITIONAL RESOURCES

(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(B) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996) International Conference on Harmonisation, Geneva, Switzerland

Relevant Section: 4.8

(C) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995) World Health Organization, Geneva, Switzerland

Relevant Section: 8

REQUIREMENTS

(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French/Français) (June 19, 1997)
National Assembly of the Republic of Guinea, Republic of Guinea

Relevant Sections: Book Three, Chapters I, III, and IV

Informed Consent > Special Circumstances/Emergencies
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SUMMARY

Overview
The Guinea-PHC makes provisions to protect the rights of a research participant during the informed consent process when the procedure is complicated by special circumstances. Special circumstances include medical emergencies and when a participant is mentally incapacitated.

Medical Emergencies
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.

Per Additional Resource (A) and in-country subject matter experts, clinical trials must comply with informed consent requirements in the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) and the World Health Organization’s good clinical practice guidelines (WHO-GCPs).

ADDITIONAL RESOURCES

(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(B) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996) International Conference on Harmonisation, Geneva, Switzerland

Relevant Section: 4.8

(C) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995) World Health Organization, Geneva, Switzerland

Relevant Section: 8

REQUIREMENTS

(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French/Français) (June 19, 1997)
National Assembly of the Republic of Guinea, Republic of Guinea

Relevant Section: Book Three, Chapter I

Informed Consent > Vulnerable Populations
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SUMMARY

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 are persons because of his/her situation or mental state, cannot give a fully free and informed consent, 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 Additional Resource (A) and in-country subject matter experts, clinical trials must comply with informed consent requirements in the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) and the World Health Organization’s good clinical practice guidelines (WHO-GCPs).

ADDITIONAL RESOURCES

(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(B) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996) International Conference on Harmonisation, Geneva, Switzerland

Relevant Section: 4.8

(C) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995) World Health Organization, Geneva, Switzerland

Relevant Section: 8

REQUIREMENTS

(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French/Français) (June 19, 1997)
National Assembly of the Republic of Guinea, Republic of Guinea

Relevant Section: Book Three, Chapter I

Informed Consent > Children/Minors
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SUMMARY

Overview
Guinea’s definition of 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 Additional Resource (A) and in-country subject matter experts, clinical trials must comply with informed consent requirements in the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) and the World Health Organization’s good clinical practice guidelines (WHO-GCPs).

ADDITIONAL RESOURCES

(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(B) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996) International Conference on Harmonisation, Geneva, Switzerland

Relevant Section: 4.8

(C) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995) World Health Organization, Geneva, Switzerland

Relevant Section: 8

REQUIREMENTS

(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French/Français) (June 19, 1997)
National Assembly of the Republic of Guinea, Republic of Guinea

Relevant Section: Book Three, Chapter I

Informed Consent > Pregnant Women, Fetuses & Neonates
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SUMMARY

Overview
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 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

Any research promoting abortion as provided for in section 269 of the Penal Code is prohibited.

Per Additional Resource (A) and in-country subject matter experts, clinical trials must comply with informed consent requirements in the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) and the World Health Organization’s good clinical practice guidelines (WHO-GCPs).

ADDITIONAL RESOURCES

(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(B) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996) International Conference on Harmonisation, Geneva, Switzerland

Relevant Section: 4.8

(C) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995) World Health Organization, Geneva, Switzerland

Relevant Section: 8

REQUIREMENTS

(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French/Français) (June 19, 1997)
National Assembly of the Republic of Guinea, Republic of Guinea

Relevant Section: Book Three, Chapter I

Informed Consent > Prisoners
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SUMMARY

Overview
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.

As indicated in the Guinea-PHC, 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.

Per Additional Resource (A) and in-country subject matter experts, clinical trials must comply with informed consent requirements in the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) and the World Health Organization’s good clinical practice guidelines (WHO-GCPs).

ADDITIONAL RESOURCES

(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(B) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996) International Conference on Harmonisation, Geneva, Switzerland

Relevant Section: 4.8

(C) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995) World Health Organization, Geneva, Switzerland

Relevant Section: 8

REQUIREMENTS

(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French/Français) (June 19, 1997)
National Assembly of the Republic of Guinea, Republic of Guinea

Relevant Section: Book Three, Chapter I

Informed Consent > Mentally Impaired
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SUMMARY

Overview
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 Additional Resource (A) and in-country subject matter experts, clinical trials must comply with informed consent requirements in the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) and the World Health Organization’s good clinical practice guidelines (WHO-GCPs).

ADDITIONAL RESOURCES

(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(B) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996) International Conference on Harmonisation, Geneva, Switzerland

Relevant Section: 4.8

(C) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO-GCPs) (Technical Report Series No. 850, Annex 3) (1995) World Health Organization, Geneva, Switzerland

Relevant Section: 8

REQUIREMENTS

(1) (Legislation) Code of Public Health of Guinea (Guinea-PHC - French/Français) (June 19, 1997)
National Assembly of the Republic of Guinea, Republic of Guinea

Relevant Section: Book Three, Chapter I

Investigational Products > Definition of Investigational Product
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SUMMARY

Overview
As per Additional Resource (A) and an in-country subject matter expert, the sponsor or his/her representative must define investigational products (IPs) in accordance with the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products and the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs). See Additional Resources (B) and (C) for further information on IPs.

ADDITIONAL RESOURCES

(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(B) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (Annex 3) (WHO Technical Report Series, No. 850) (1995)
World Health Organization, Geneva, Switzerland

Relevant Sections: Glossary and 5.6

(C) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Sections: 1.33, 5.12, 5.13, and  5.14

REQUIREMENTS

No applicable regulatory requirements

Investigational Products > Manufacturing & Import
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SUMMARY

Overview
According to Additional Resources (A) and (B), the Ministry of Health and Public Hygiene (MOHPH)’s National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire) (DNPL) is responsible for authorizing the manufacture and import of drug products in Guinea. Specific information concerning the DNPL’s role in reviewing and approving the manufacture of investigational products (IPs) is not currently available.

According to Additional Resource (A), once the sponsor or his/her representative obtains ethics committee approval from the National Ethics Committee for Research in Health (Comité National d'Ethique pour la Recherche en Santé) (CNERS), he/she must submit a written request to the DNPL director to obtain approval to import IPs.  Additional Resource (A) also indicates that it typically takes two (2) to four (4) weeks for the DNPL approval process to be completed. Information pertaining DNPL documentation submission requirements is not currently available.

In addition, according to Additional Resource (C) and an in-country subject matter expert, the sponsor or his/her representative must comply with manufacturing practices delineated in the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products and the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs). See Additional Resources (D) and (E) for detailed IP manufacturing requirements.

ADDITIONAL RESOURCES

(A) (Document) Republic of Guinea - Pharmaceutical Sector Country Profile Questionnaire (French/Français) (2011)
Ministry of Health and Public Hygiene and the World Health Organization, Geneva, Switzerland

Relevant Section: 5.0 – Pharmaceutical Regulation

(B) (Report) Evaluation of the Regulation of the Pharmaceutical Sector in Guinea (French/Français) (2013)
Systems for Improved Access to Pharmaceuticals and Services (SIAPS), Guinea

Relevant Section: Appendix 2

(C) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(D) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (Annex 3) (WHO Technical Report Series, No. 850) (1995)
World Health Organization, Geneva, Switzerland

Relevant Section: 5.6

(E) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Section: 5.13

REQUIREMENTS

No applicable regulatory requirements

Investigational Products > IMP/IND Quality Requirements
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SUMMARY

Overview
No information is currently available regarding the sponsor’s role in providing principal investigators with an Investigator’s Brochure (IB) or with IB content requirements. National Directorate of Pharmacy and Laboratory (Direction Nationale de la Pharmacie et du Laboratoire) (DNPL) documentation submission requirements are also unavailable.

According to Additional Resource (A) and an in-country subject matter expert, the sponsor or his/her representative must comply with the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products and the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) in the production, supply, storage, and handling of investigational products (IPs). See Additional Resources (B) and (C) for more detailed IP requirements.

ADDITIONAL RESOURCES

(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(B) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (Annex 3) (WHO Technical Report Series, No. 850) (1995)
World Health Organization, Geneva, Switzerland

Relevant Section: 5.6

(C) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Section: 1.33

REQUIREMENTS

No applicable regulatory requirements

Investigational Products > Labeling & Packaging
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SUMMARY

Overview
According to Additional Resource (A) and an in-country subject matter expert, the sponsor or his/her representative must comply with the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products and the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) in the labeling of investigational products (IPs).

Further detailed information on specific labeling IP requirements is currently unavailable.

ADDITIONAL RESOURCES

(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(B) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (Annex 3) (WHO Technical Report Series, No. 850) (1995)
World Health Organization, Geneva, Switzerland

Relevant Section: 5.6

(C) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Section: 1.33

REQUIREMENTS

No applicable regulatory requirements

Investigational Products > Product Management
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SUMMARY

Overview
No information is currently available regarding the sponsor’s role in providing investigators with an Investigator’s Brochure.

Investigational Product Supply, Storage, and Handling Requirements
According to Additional Resource (A) and an in-country subject matter expert, the sponsor or his/her representative must comply with the World Health Organization’s (WHO) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products and the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) in the production, supply, storage, and handling of investigational products (IPs).

Further detailed information on specific IP requirements that the sponsor or his/her representative must ensure is currently unavailable.

ADDITIONAL RESOURCES

(A) NIAID Communication with United States Centers for Disease Control and Prevention (CDC) Resident Advisor in Guinea (not available online) (February 2015)

(B) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (Annex 3) (WHO Technical Report Series, No. 850) (1995)
World Health Organization, Geneva, Switzerland

Relevant Section: 5.6

(C) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Sections: 5.12, 5.13, and 5.14

REQUIREMENTS

No applicable regulatory requirements

Specimens > Definition of Specimen
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SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Specimens > Import & Export
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SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Specimens > Consent for Specimens
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SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

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Expiration Date: 2/28/2019