NAFDAC Guidelines on Registration Requirements to Establish Interchangeability of Generic Pharmaceutical Products
Guideline · Health
Guidelines specify requirements for bioequivalence studies to prove generic medicines are interchangeable with reference products. They target regulated entities, NAFDAC teams, and industry stakeholders. This promotes access to affordable generics while ensuring their effectiveness.
NAFDAC Guidelines on Registration Requirements to Establish Interchangeability of Generic Pharmaceutical Products
What Is This Policy?
Technical guidelines specifying the bioequivalence and pharmaceutical equivalence studies required to demonstrate that a generic medicine can be substituted for the reference product.
Who Does It Target?
Generic pharmaceutical manufacturers in Nigeria seeking to register medicines as interchangeable with branded originator products; contract research organisations conducting bioequivalence studies; NAFDAC's scientific evaluation and registration teams
NAFDAC teams Industry stakeholders
What Does It Aim to Achieve?
Facilitate access to affordable generic medicines while ensuring they perform equivalently to the innovator product.
Key Features
Bioequivalence Studies: In-vivo study design, conduct, and reporting requirements Biowaivers: Conditions under which in-vivo studies may be waived based on BCS classification Reference Products: Criteria for selecting appropriate reference products for comparison Study Standards: GCP and GLP compliance for bioequivalence studies
Current Status
Rollout Stage: Active Coverage: All applicable entities Lead Agency: NAFDAC
How to Access
Regulated entities must comply. Identify the appropriate reference product Design and conduct bioequivalence or biowaiver studies per guidelines Submit study reports with registration application
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 on WHO guidelines on interchangeable multisource pharmaceutical products and the ICH Q6A specifications for drug products.