The National Agency for Food and Drug Administration and Control, NAFDAC, has announced stringent requirements for registering pharmaceutical products starting January 2024.
Prof Mojisola Adeyeye, the director general of NAFDAC, disclosed this in a statement through its official X account on Wednesday.
Accordingly, the agency stated that the quality of active pharmaceutical ingredients used in finished pharmaceutical products impacts their safety and efficacy.
“To this end, NAFDAC wishes to inform all stakeholders intending to submit dossiers for product registration starting from January 2024 that only applications supported by APIs or FPPs sourced from any of the under-listed approved sources will be accepted for review.
“These are APIs with certificates of suitability to the monographs of the European Pharmacopoeia (CEP); APIs and FPPs sourced from facilities certified by PlC/S. participating Authorities; APIs sourced from facilities certified by Stringent Regulatory Authorities (SRA) or WHO Listed Authorities (WLA) and APIs certified by accredited quality control laboratories.
“Furthermore, all excipients to be used in the manufacture of finished pharmaceutical products must be of pharmacopoeia grade and must be from an ISO-9001:2015 or EXCIPACT-certified facility,” it stated.
It added that companies with registered FPPs who have not sourced their APIs or excipients from any listed sources must provide evidence by January 2027 of a source change to another manufacturer that satisfies any of the provisions listed above.
NAFDAC announces stringent requirements for pharmaceutical products registration
