NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guideline on Registration Requirements to Establish Interchangeability of Generic Pharmaceutical Products
Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria
This document is an adaptation of the World Health Organization (WHO) guidelines on registration requirements to establish interchangeability. It provides appropriate In vivo and In vitro requirements to assure interchangeability of the generic product without compromising the safety, quality and efficacy of the pharmaceutical product and is generally applicable to orally administered generic products as well as to certain non-orally administered pharmaceutical products (e.g. transdermal delivery systems and certain parenteral, rectal and nasal pharmaceutical products.
Process Flow
Department of Registration and Regulatory Affairs ⬤
Office of the Director General NAFDAC ⬤
Office of the Permanent Secretary, Ministry of Health ⬤
Office of the Minister of State for Health ⬤
Office of the Minister of Health ⬤
Federal Executive Council ⬤
NAFDAC Registration & Regulatory Affairs (R & R) Directorate Guideline on Registration Requirements to Establish Interchangeability of Generic Pharmaceutical Products Current Version
January 2022
This document is an adaptation of the World Health Organization (WHO) guidelines on registration requirements to establish interchangeability. It provides appropriate In vivo and In vitro requirements to assure interchangeability of the generic product without compromising the safety, quality and efficacy of the pharmaceutical product and is generally applicable to orally administered generic products as well as to certain non-orally administered pharmaceutical products (e.g. transdermal delivery systems and certain parenteral, rectal and nasal pharmaceutical products.
Thank you for requesting an expert analysis
A member of our team will review your request and reply back to the email address on file.