CLINICAL TRIAL REGULATIONS
Regulation · Health
Regulations govern the conduct of clinical trials for medicines in Nigeria, ensuring ethical standards and participant safety. They target pharmaceutical companies, research organizations, and ethics committees. This protects participants and maintains scientific integrity.
What Is This Policy?
Regulations governing the conduct of clinical trials for medicines and related products in Nigeria, ensuring ethical standards, participant safety, and scientific integrity.
Who Does It Target?
Pharmaceutical companies, clinical research organizations, research institutions, ethics committees, and clinical trial participants.
What Does It Aim to Achieve?
Ensure clinical trials are conducted ethically and safely, protect trial participants' rights and welfare, and maintain scientific integrity of clinical research data.
Key Features
Ethics Review: Mandatory ethics committee approval before trial commencement. Informed Consent: Requires documented informed consent from all trial participants. Safety Monitoring: Mandates adverse event reporting and safety monitoring throughout trials. GCP Compliance: Trials must comply with Good Clinical Practice guidelines.
Current Status
Rollout Stage: Active and enforceable. Coverage: All clinical trials conducted in Nigeria. Funding: NAFDAC regulatory fees and trial sponsor funding.
How to Access
Sponsors must apply to NAFDAC for clinical trial authorization. Submit clinical trial application to NAFDAC Obtain ethics committee approval Register trial and begin upon NAFDAC authorization Portal: nafdac.gov.ng
Important Terms
Non-compliance may result in trial suspension, fines, or prosecution. Participant safety takes priority.
Impact & Metrics
Ensures safe and ethical clinical research in Nigeria and promotes Nigeria as a research destination.
Official Resources
Website: https://www.nafdac.gov.ng Contact: NAFDAC Clinical Trial Unit, Abuja
Legal Framework
Issued under the regulatory powers of the National Agency for Food and Drug Administration and Control (NAFDAC) pursuant to the NAFDAC Act. Operates alongside the National Health Act 2014 on research ethics, the National Health Research Ethics Committee (NHREC) guidelines, and the Nigeria Data Protection Act 2023 on participant data. Aligns with the ICH Good Clinical Practice (GCP) guidelines, the Declaration of Helsinki, and the CIOMS International Ethical Guidelines.