NAFDAC Good Clinical Practice Guidelines 2016
Guideline · Health
Policy date: 2016-01-01
Guidelines establish ethical and scientific standards for designing, conducting, recording, and reporting clinical trials in Nigeria. They target investigators, sponsors, and regulatory bodies. This protects participants and ensures the integrity of trial data.
NAFDAC Good Clinical Practice Guidelines 2016
What Is This Policy?
Guidelines establishing the ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials in Nigeria, aligned with the ICH-GCP framework.
Who Does It Target?
Clinical trial sponsors and contract research organisations conducting trials in Nigeria; principal investigators and clinical researchers at trial sites; ethics committees reviewing and approving trial protocols; NAFDAC's clinical trial regulatory review teams; research institutions and teaching hospitals
NAFDAC teams Industry stakeholders
What Does It Aim to Achieve?
Protect clinical trial participants and ensure the credibility and integrity of clinical trial data generated in Nigeria.
Key Features
Ethical Requirements: Informed consent, ethics committee review, and participant protection Investigator Responsibilities: Qualifications, training, and conduct requirements for trial investigators Sponsor Obligations: Protocol design, monitoring, adverse event reporting, and data management Documentation: Essential documents that must be maintained before, during, and after trials NAFDAC Oversight: GCP inspection and compliance monitoring by NAFDAC
Current Status
Rollout Stage: Active Coverage: All applicable entities Lead Agency: NAFDAC
How to Access
Regulated entities must comply. Design trials per GCP standards Obtain ethics committee and NAFDAC approvals Maintain all essential documents throughout the trial
Official Resources
Website: nafdac.gov.ng Contact: NAFDAC, Abuja
Legal Framework
The NAFDAC Good Clinical Practice Guidelines 2016 are issued under the NAFDAC Act and operate alongside the National Health Act 2014 (Section 22 on research ethics), the Health Research Ethics Guidelines, and the Medical and Dental Practitioners Act. International alignment is with the ICH E6 (R2) Good Clinical Practice Guidelines, the Declaration of Helsinki on medical research involving human subjects, and the WHO Good Clinical Practice guidelines for developing countries.