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:

1. Professor John  Gyapong                          Epidemiologist(Chairman)
2. Professor Kenneth Adjepong-Yamoah   Clinical Pharmacologist
3. Professor Alexander Nyarko Toxicologist, Pharmacologist
4. Professor Richard Biritwum Biostatistician
5. Dr. Edem Tette   Paediatrician
6. Dr. Ayaga Bawah Social Scientist
7. Dr. Jonathan Dakubo Surgical Specialist
8. Dr. Edwin Ferguson laing   Clinical Pathologist
9. Dr. Henry J.O. Lawson   Family Medicine Specialist(Geriatrician)
10. Dr. Yaw Asante Awuku Internal Medicine Practitioner
11. Mrs. Florence Amah Nkansah  Clinical Pharmacist
12. 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 Ghana.General Programs and Activities of the Department include amongst others;

  1. Clinical Trial Application Review
  2. GCP Inspections at trial sites
  3. GCP Training for investigators and study team (general or customized).
  4. Acting as the secretariat of the Technical Advisory Committee on Clinical Trials.
  5. Review of importation permits for investigational products used in the conduct of clinical trials
  6. Review of all reports for clinical trials (safety reports, quarterly reports, close-out reports, serious adverse report and final clinical trial reports).
  7. Pre-submission /client service meetings to discuss issues related to Applications or any related issues regarding conduct of clinical trials in Ghana.
  8. 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
  1. Receiving of Clinical Trial Applications (CTAs)
  2. Planning, scheduling and coordinating of CTA evaluation meetings
  3. Evaluation of CTAs and amendments
  4. Correspondence of evaluation on CTAs and amendments to applicants
  5. Processing of permits for Investigational Products
  6. Acknowledgement of general correspondences
  7. Coordinating and planning of Technical Advisory Committee (TAC) meetings
  8. Developing and updating relevant information on the FDA website
  • Clinical Trials Compliance Unit
  1. Update and maintenance of data on approved clinical trials
  2. Receipt, evaluation and acknowledgement of serious Adverse Event (SAE) reports
  3. Processing SAEs for Technical Advisory Committee(TAC) meetings
  4. Planning and coordinating GCP inspections for on-going studies
  5. Conducting GCP inspections at trial sites of on-going studies
  6. Organizing good Clinical Practice trainings for Research Institutions
  7. Coordinating training workshops (Internal & External)
  8. 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 Good Clinical Practice (GCP) in Ghana
  • Guidelines for Conduct of Clinical Trials in Paediatric Population
  • Guideline for Conduct of Clinical Trials During Emergencies
  1. Standard Operating Procedures (SOPs) for carrying out Departmental activities
  2. Clinical Trial Application Form ( completed and submitted together with other documents during a clinical trial application submission)
  3. Quarterly Progress Report Form ( trial sites report progress of approved on-going trials quarterly)
  4. Clinical Trial Close-out Report Form ( submitted by trial when trial ends and close-out activities have been carried out))
  5. 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;

  1. GCP Inspectors Notes
  2. GCP Observation Sheet
  3. GCP Inspection Checklist
  4. In-house Evaluation Forms

 For further enquiries, kindly contact the Clinical Trials Department on +233244310297 or through drug.safety@fdaghana.gov.gh

About Clinical Trials Regulation in Ghana:

REGULATION OF CLINICAL TRIALS IN GHANA

Clinical Trials Application Form:

APPLICATION FORM FOR CONDUCT OF CLINICAL TRIAL

Clinical Trials Operational Guidelines:

GUIDELINES FOR AUTHORIZATION OF CLINICAL TRIALS OF MEDICINES, FOOD SUPPLEMENTS, VACCINES AND MEDICAL DEVICES IN GHANA

GUIDELINES FOR CONDUCT OF CLINICAL TRIALS IN PAEDIATRIC POPULATION

GUIDELINES FOR CONDUCT OF CLINICAL TRIALS DURING EMERGENCIES

GUIDELINES FOR GOOD CLINICAL PRACTICE IN GHANA

Timelines and Application Processes:

TIMELINES AND APPLICATION PROCESSES

Registry:

THE FDA CLINICAL TRIALS REGISTRY

Committee Meeting Schedules:

TECHNICAL ADVISORY COMMITTEE ON CLINICAL TRIALS MEETING SCHEDULE

Clinical Trials Reporting Forms:

CLINICAL TRIALS QUARTERLY REPORTING FORM

CLINICAL TRIALS CLOSE-OUT REPORTING FORM

See Also

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