NAFDAC Guidelines for Conduct of Clinical Trials During Emergencies
Guideline · Health
Guidelines define how to conduct clinical trials for treatments during health emergencies in Nigeria. They target trial sponsors and ethics committees, requiring expedited reviews and safety measures. This allows rapid responses while protecting participants.
NAFDAC Guidelines for Conduct of Clinical Trials During Emergencies
What Is This Policy?
Expedited guidelines that define how clinical trials for investigational treatments and vaccines may be designed, approved, and conducted in Nigeria during public health emergencies such as epidemics and pandemics.
Who Does It Target?
Clinical trial sponsors and investigators Research ethics committees NAFDAC clinical trials evaluation team Healthcare facilities serving as trial sites
What Does It Aim to Achieve?
Enable rapid but ethical conduct of clinical trials during health emergencies by providing expedited review pathways while maintaining participant safety and data integrity.
Key Features
Expedited Review: Fast-tracked NAFDAC review and approval timelines for emergency trial protocols Ethical Standards: Informed consent, ethics committee review, and participant protection remain mandatory Data Collection: Requirements for real-time safety monitoring and interim data reporting Regulatory Flexibility: Provisions for protocol amendments and adaptive trial designs during evolving emergencies Post-Trial Access: Considerations for continued access to investigational products after trial completion
Current Status
Rollout Stage: Active Coverage: All applicable regulated entities Lead Agency: NAFDAC Enforcement: NAFDAC inspections and compliance monitoring
How to Access
Regulated entities must comply with these guidelines. Submit trial protocols through NAFDAC's expedited emergency pathway Obtain ethics committee approval Implement robust safety monitoring throughout the trial
Official Resources
Website: nafdac.gov.ng Contact: NAFDAC, Abuja
Legal Framework
Issued under the National Agency for Food and Drug Administration and Control Act 1993 (as amended). Operates alongside the National Code for Health Research Ethics 2007, the ICH E6 Good Clinical Practice Guidelines, the WHO Guidance on Clinical Trials, and the Nuremberg Code principles as adopted in Nigerian health research policy.