Clinical Trials Authorization
The Food and Drugs Authority (FDA) Ghana plays a central role in safeguarding public health by regulating the conduct of clinical trials within the country. Through its Clinical Trials Function, the FDA ensures that all clinical trials are conducted to the highest standards of ethics, quality, and scientific integrity, in line with ICH Good Clinical Practices (GCP) standards, national regulations and global best practices.
The FDA is the final body responsible for authorizing the initiation and conduct of clinical trials in the country, following approval by the requisite Ethics Committee(s). This mandate ensures that only trials meeting both ethical and scientific standards proceed in Ghana. A person shall not conduct a clinical trial of a drug, herbal medicinal product, cosmetic, medical device or procedure without an approved valid certificate issued by the Authority.
In July 2024, the FDA’s Clinical Trials Function achieved a historic milestone by attaining Maturity Level 4 (ML-4) in Clinical Trials Oversight under the World Health Organization (WHO) Global Benchmarking Tool (GBT). This recognition makes Ghana the first regulatory authority in Africa to achieve this level of regulatory excellence in Clinical Trials Oversight. Maturity Level 4 in Clinical Trials Oversight signifies that the FDA’s Clinical Trials Function is well-functioning and operates at an advanced level of performance and continuous improvement.
The Food and Drugs Authority Legal Mandate for Clinical Trial (CT) Regulation is provided under Part 8, Sections 150-166, of the Public Health Act (PHA), 2012, Act 851.
The legal provisions include:
- • Development of Guidelines (Sec. 148 of Act 851)
• Establishment of Technical Advisory Committee and its TORs and composition
• Procedure to apply to conduct a trial and information to submit in support of application
• FDA’s authority to investigate trials
• Appeal process
• Conditions under which a trial may be conducted
• FDA’s power to stop or suspend trial
• Monitoring of clinical trials
• Submission of reports on clinical trials
• Validity of clinical trial certificate and renewal
• Penalties
The FDA’s Clinical Trials Oversight Function 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 these trials are credible and accurate to support the safety and efficacy for all drugs, 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. In order to achieve the above, a Technical Advisory Committee on Clinical Trials (TAC-CT) has been set up to provide the Clinical Trials Department with ongoing and timely medical and scientific advice on current and emerging issues related to clinical trials.
The Department regularly collaborates with other stakeholders to deliberate on current trends, challenges and the way forward for regulating Clinical Trials worldwide.
Clinical trials shall be categorized as follows:
- 1. Trials directed by The Authority.
- 2. Trials initiated by pharmaceutical companies or agencies.
- 3. Trials initiated by academic and research institutions either locally or as part of an international multi-centre study.
Requirements for Clinical Trial Application (CTA)
A Clinical Trial Application made to The Authority shall be accompanied by the following:
- 1. Covering Letter
2. A non-refundable Application Fee as per the prescribed Fee Schedule.
3. Completed Food and Drugs Authority Application Forms for Conducting Clinical Trials signed by authorized persons (PI and Sponsor’s authorized representative).
4. A Clinical Trial Protocol
5. A proof of registration with Pan African Clinical Trials Registry (PACTR)
6. Investigator’s Brochure (IB)
7. Investigational Product (IP) Dossier
8. Good Manufacturing Practice (GMP) Certificate
9. Ethics Committee (EC)/Institutional Review Board (IRB) Approval (at least evidence of submission of application to EC/IRB if final approval is not yet available)
10. Insurance Cover for all study participants
11. Financial Declaration
12. DSMB Membership and signed Charter
13. Sponsor/PI Contractual Agreement
14. Sponsor and Monitor/Contract Research Organization Contractual Agreement
15. Informed Consent and Assent Forms (if applicable)
16. Statistical Analysis Plan (SAP)
17. Materials Transfer Agreement (if applicable)
18. Financial Disclosure
All clinical trial application documents shall be submitted in hard and soft copies (1 each; format of soft copy of documents submitted should be in searchable PDF).
Note:
- A Clinical Trial Application shall be rejected if upon preliminary assessment at the time of submission, less than 70% of the required documents as per Section 3.1 are available. This 70% shall include the application fee, a duly signed protocol, IB, completed FDA application form and application fee.
- For Academic Trials, academic supervisors shall make submissions on behalf of their students
- Failure of applicant to address all outstanding issues related to an application within a year renders an application null and void.
- The application shall indicate the phase of clinical trial intended
- Regarding Clinical Trials approved by a well-resourced NRA, the FDA shall activate the reliance pathway to facilitate regulatory decisions either on a case-by-case basis or at the Applicant’s explicit request. The Applicant shall submit the full CTA as listed in section 3.1 of the FDA’s guideline for Authorization of Clinical Trials in Ghana, and the full Assessment reports of the CTA submitted to the well-resourced NRA for approval. The application (protocol, IB, nonclinical reports, previous study reports and other relevant documents) shall be identical to that submitted, evaluated and approved by the well-resourced NRA or reference NRA. Refer to FDA’s Reliance Policy for details on Reliance Authorization Pathway.
- To ensure transparency, summarized review comments on Clinical Trial Applications shall be published as a Public Assessment Report on the Authority’s website in a prescribed format outlined in the FDA’s guideline on the Content and Procedure for Development and Publication of Public Assessment Reports for Clinical Trial Applications. The status of all clinical trial applications received shall be updated on the Clinical Trials Registry and published on the FDA website.
