Clinical trials Department

Legal Mandate
The FDA was formally mandated by the Food and Drugs Law of 1992, PNDCL 305B and its amendment, Act 523. In 2012, this law was reviewed and the Public Health Act (PHA) 2012, Act 851 was passed to increase the scope and enhance public health and safety. Part 8, Sections 150-166 of the PHA 2012, Act 851 mandates the FDA to regulate Clinical Trials.

The legal mandate of the FDA as per the PHA is to authorize and monitor clinical trials through;

• Development of appropriate guidelines for the conduct of clinical trials
• Issuance of CT Certificates (permit for conducting clinical trials)
• Reviewing of all reports from trial sites
• Conducting Good Clinical Practice(GCP) inspection at trials sites to ensure compliance of trials to international best practices and local regulatory requirements
• Investigating the conduct of clinical trial
• Suspension or stopping clinical trials(if necessary)

The Technical Advisory Committee on Clinical Trials

To satisfy requirements of the law, 12-member experts committee(an advisory Committee on Clinical Trials), whose objective is to provide the FDA with ongoing and timely medical and scientific advice on current and emerging issues related to clinical trials, has been established. Current members of the Committee with their respective expertise are as follows:

Professor John Gyapong                              Epidemiologist(Chairman)
Professor Kenneth Adjepong-Yamoah    Clinical Pharmacologist
Professor Alexander Nyarko                       Toxicologist, Pharmacologist
Professor Richard Biritwum                         Biostatistician
Dr. Edem Tette                                                 Paediatrician
Dr. Ayaga Bawah                                             Social Scientist
Dr. Jonathan Dakubo                                    Surgical Specialist
Dr. Edwin Ferguson laing                             Clinical Pathologist
Dr. Henry J.O. Lawson                                   Family Medicine Specialist(Geriatrician)
Dr. Yaw Asante Awuku                               Internal Medicine Practitioner
Mrs. Florence Amah Nkansah                 Clinical Pharmacist
Ms. Mavis Boakye-Yiadom                        Medical Herbalist
The Clinical Trials Department

The Clinical Trials Department of the FDA is responsible for authorization and monitoring of clinical trials as required by the Public Health Act. The Department aims to implement the appropriate and modern regulatory measures to achieve the highest standard for design, conduct, recording and reporting of clinical trials in Ghana such that data and results from cosmetics, household chemical substances and medical devices that are locally manufactured, imported, exported, distributed, sold, or used.

This will ensure the protection of the consumer as envisaged by the laws regulating food and drugs in force in Cameroon .General Programs and Activities of the Department include amongst others;

Clinical Trial Application Review
GCP Inspections at trial sites
GCP Training for investigators and study team (general or customized).
Acting as the secretariat of the Technical Advisory Committee on Clinical Trials.
Review of importation permits for investigational products used in the conduct of clinical trials
Review of all reports for clinical trials (safety reports, quarterly reports, close-out reports, serious adverse report and final clinical trial reports).
Pre-submission /client service meetings to discuss issues related to Applications or any related issues regarding conduct of clinical trials in Cameroon.
Stakeholder engagement activities including seminars for institutions and professional bodies.
Currently the Department has two(2) units with the following activities as follows;

Clinical Trials Authorization Unit
Receiving of Clinical Trial Applications (CTAs)
Planning, scheduling and coordinating of CTA evaluation meetings
Evaluation of CTAs and amendments
Correspondence of evaluation on CTAs and amendments to applicants
Processing of permits for Investigational Products
Acknowledgement of general correspondences
Coordinating and planning of Technical Advisory Committee (TAC) meetings
Developing and updating relevant information on the FDA website
Clinical Trials Compliance Unit
Update and maintenance of data on approved clinical trials
Receipt, evaluation and acknowledgement of serious Adverse Event (SAE) reports
Processing SAEs for Technical Advisory Committee(TAC) meetings
Planning and coordinating GCP inspections for on-going studies
Conducting GCP inspections at trial sites of on-going studies
Organizing good Clinical Practice trainings for Research Institutions
Coordinating training workshops (Internal & External)
Receipt and review clinical trial reports (quarterly and final)
The Clinical Trials Department in carrying out its mandate and activities uses the the underlisted tools. These are reviewed and updated periodically when necessary to ensure they continue to be in line with ICH Guidelines and international best practices.

1. Four (4) guidelines;

Guidelines for authorization of Clinical Trials of Medicines, Food Supplements, Vaccines and Medical Devices in Cameroon
Guidelines for Good Clinical Practice (GCP) in Cameroon
Guidelines for Conduct of Clinical Trials in Paediatric Population
Guideline for Conduct of Clinical Trials During Emergencies
2. Standard Operating Procedures (SOPs) for carrying out Departmental activities

3. Clinical Trial Application Form ( completed and submitted together with other documents during a clinical trial application submission)

4. Quarterly Progress Report Form ( trial sites report progress of approved on-going trials quarterly)

5. Clinical Trial Close-out Report Form ( submitted by trial when trial ends and close-out activities have been carried out))

6. Final Clinical Trial Report Form ( format used in reporting final trial reports at the end of trials, that is ICH E3)

Other administrative tools used include;

7. GCP Inspectors Notes

8. GCP Observation Sheet

9. GCP Inspection Checklist

10. In-house Evaluation Forms

For further enquiries, kindly contact the Clinical Trials Department on  through

About Clinical Trials Regulation in Cameroon

Clinical Trials Application Form

Clinical Trials Operational Guidelines

Timelines and Application Processes

Registry

Committee Meeting Schedules

Clinical Trials Reporting Forms