NAFDAC Guidelines for Importation and Release of Investigational Medicinal Products
Guideline · Trade
Guidelines govern the importation and release of investigational medicinal products for clinical trials in Nigeria. They target clinical trial sponsors, NAFDAC units, customs agents, and pharmacists. The aim is to maintain product quality and safety during trials.
NAFDAC Guidelines for Importation and Release of Investigational Medicinal Products
What Is This Policy?
Guidelines governing the import clearance and release of medicines being used in approved clinical trials in Nigeria, ensuring proper documentation, quality, and regulatory oversight.
Who Does It Target?
Clinical trial sponsors importing investigational products NAFDAC clinical trials unit Customs clearing agents handling trial materials Clinical trial site pharmacists
What Does It Aim to Achieve?
Facilitate the timely importation of investigational medicinal products while ensuring proper documentation, quality control, and accountability for products used in clinical trials.
Key Features
Import Authorization: NAFDAC approval required before importing investigational products Documentation: Trial approval letter, product specifications, certificates of analysis, and shipping records Labelling: Investigational product labelling requirements per ICH-GCP guidelines Storage: Appropriate storage conditions at the trial site pharmacy Accountability: Detailed records of receipt, dispensing, and return or destruction of unused products
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. Obtain NAFDAC import authorization before shipment Clear products through ports with required documentation Maintain full accountability records at the trial site
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.