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.

To ensure easy access to medical products, the FDA has developed and implemented alternative /non-routine Clinical Trials Authorization pathway (refer to Appendix III) to the standard approval pathway especially for applications where the Clinical Trial has already been approved and/or initiated (partly or wholly – phase I/II/III) in a well-resourced setting and by a well-resourced regulatory authority. The Authority relies on and uses relevant Clinical Trial decisions, reports or information from well-resourced regulatory authorities or from regional and international bodies. That notwithstanding, it is equally important to note that the Authority reserves the right to request for information or material, or define conditions not specifically described in the FDA’s Guidelines for the Authorization of Clinical Trials of Medicines, Food Supplements, Vaccines and Medical Devices In Ghana or the FDA’s Reliance Policy, to allow the Department to adequately assess the safety, efficacy or quality of a product. The Authority is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

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. Informed Consent and Assent Forms (if applicable) 15. Statistical Analysis Plan (SAP) 16. Materials Transfer Agreement (if applicable) 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.
• 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; see Appendix III of these Guidelines.
• With regard to the review of CTAs and amendments

1. FDA reviews the documents submitted to assess the quality of the investigational products and determine that the use of the investigational product for the purposes of the clinical trial does not cause any harm to the health or pose undue risk to the health of clinical trial participants or other persons; the clinical trial is not contrary to the best interests of a clinical trial participants, and the objectives of the clinical trial may be achieved.
2. Assessment of documents shall involve evaluators from within the FDA and external experts from outside when needed.

• The FDA may, during evaluation, request for clarification, extra documents and/or samples through a letter indicating the queries. Immediately a query has been raised and issued to the applicant, the evaluation process shall stop until FDA receives an official response to the query, and then clock restarts. Queries are to be addressed within 6 months, after which period the application shall be treated as a new one. To facilitate the review process, all queries issued in the same letter must be addressed in a single submission.

1. Non-compliance and non-conformity to the requirements prescribed in these guidelines shall lead to rejection of the clinical trial.
2. A decision to defer, approve or reject an application shall be done within sixty (60) working days for a routine application (refer to Appendix II), thirty (30) working days for an abridged evaluation after the reliance pathway has been activated, (refer to Appendix III) and twenty-one (21) working days for trials that have to be conducted during emergency situations (refer to Guidelines for Conduct of Clinical Trials during Emergencies).
3. In the event of a rejection of an application, an applicant may appeal to the Minister of Health within sixty (60) working days in writing. The applicant shall give grounds for review for each reason given for the rejection of the clinical trial based on the information submitted in the application. Where a representation is not submitted by the applicant within sixty (60) days, the decision of the Authority in respect of the application shall stand.

• The FDA reserves the right to request information or material, or define conditions not specifically described in this Guideline, in order to allow the Authority to adequately assess the safety, efficacy or quality of the investigational medicinal product.
• 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 3.1 (above) 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 on the Clinical Trial Registry on the Authority’s website in a format as per Appendix Id. However, critical information regarding the trial shall be treated with strict confidentiality. This register shall be updated on the website every quarter.