NAFDAC Unveils Stringent Requirements for Pharmaceutical Product Registration from 2024

The National Agency for Food and Drug Administration and Control (NAFDAC) has introduced rigorous requirements for the registration of pharmaceutical products, effective from January 2024. The announcement, made by Prof Mojisola Adeyeye, the Director-General of NAFDAC, through the agency’s official X account, emphasizes the impact of active pharmaceutical ingredients (APIs) on the safety and efficacy of finished pharmaceutical products.

Starting January 2024, NAFDAC will only accept registration applications supported by APIs or finished pharmaceutical products (FPPs) sourced from approved providers. These approved sources include APIs with certificates of suitability to the monographs of the European Pharmacopoeia (CEP), APIs and FPPs from facilities certified by PlC/S. participating Authorities, APIs from facilities certified by Stringent Regulatory Authorities (SRA) or WHO Listed Authorities (WLA), and APIs certified by accredited quality control laboratories.

The statement further outlines that all excipients used in the manufacturing of finished pharmaceutical products must be of pharmacopoeia grade and sourced from an ISO-9001:2015 or EXCIPACT-certified facility.

Additionally, companies with registered FPPs that haven’t obtained APIs or excipients from the specified sources must provide evidence of a source change to another manufacturer meeting the listed provisions by January 2027.

NAFDAC’s move aims to enhance the quality, safety, and efficacy of pharmaceutical products in the market, emphasizing the importance of adhering to stringent standards in the registration process.