NAFDAC Guidelines for Registration of Imported Drugs, Vaccines and In-Vitro Diagnostics Under WHO Collaborative Registration Procedure (CRP)
Guideline · Health
Guidelines facilitate the registration of imported drugs, vaccines, and diagnostics through the WHO procedure, using assessments from stringent authorities. They target importers and NAFDAC teams. This accelerates access to quality-assured medicines.
NAFDAC Guidelines for Registration of Imported Drugs, Vaccines and In-Vitro Diagnostics Under WHO Collaborative Registration Procedure (CRP)
What Is This Policy?
Guidelines for registering pharmaceutical products, vaccines, and diagnostics in Nigeria through the WHO Collaborative Registration Procedure, which leverages assessments by WHO prequalification or stringent regulatory authorities.
Who Does It Target?
Regulated entities as applicable NAFDAC inspection and compliance teams Industry stakeholders
What Does It Aim to Achieve?
Accelerate access to quality-assured medicines by using WHO prequalification assessments to streamline the NAFDAC registration process.
Key Features
Eligibility: Products must be WHO prequalified or approved by a stringent regulatory authority Abbreviated Review: Reduced documentation requirements based on prior regulatory assessment Faster Timeline: Expedited evaluation and registration decision GMP Waiver: Facility inspection may be waived based on existing WHO or SRA inspections
Current Status
Rollout Stage: Active Coverage: All applicable regulated entities Lead Agency: NAFDAC
How to Access
Regulated entities must comply with these guidelines. Confirm product eligibility under CRP Submit abbreviated application to NAFDAC Obtain registration through the expedited pathway
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 Food and Drugs Act Cap F32 LFN 2004, the Pharmacists Council of Nigeria Act, the ICH Good Manufacturing Practice guidelines, WHO prequalification standards, and the Falsified Medicines guidelines adopted by Nigeria. Draws additionally on WHO prequalification procedures for vaccines and in-vitro diagnostics and the ICH Q5 guidelines for biological products.