The National Agency for Food and Drug Administration and Control (NAFDAC) recently made a groundbreaking announcement about the stringent requirements for registering pharmaceutical products set to take effect from January 2024. The move is poised to significantly elevate the quality and safety standards of pharmaceutical products in the market.
In a statement released via its official channel, NAFDAC’s Director-General, Prof Mojisola Adeyeye, emphasized the crucial link between the quality of active pharmaceutical ingredients (APIs) and the safety and efficacy of finished pharmaceutical products. The agency underscored that the source and certification of APIs and finished pharmaceutical products (FPPs) play a pivotal role in determining their suitability for registration.
NAFDAC outlined specific criteria for the acceptance of registration applications, highlighting the approved sources for APIs and FPPs. These include 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.
Additionally, NAFDAC mandated that all excipients used in the manufacture of finished pharmaceutical products must be of pharmacopoeia grade and sourced from facilities certified under ISO-9001:2015 or EXCIPACT. This requirement underscores the agency’s commitment to ensuring the highest standards of pharmaceutical production.
Moreover, the agency laid out a transition period for companies with registered FPPs that have not conformed to the approved sources for APIs or excipients. These companies are mandated to provide evidence of a source change to manufacturers meeting the specified criteria by January 2027, further reinforcing NAFDAC’s unwavering dedication to upholding quality standards in the pharmaceutical industry.
The implications of NAFDAC’s new requirements are far-reaching, as they are poised to bolster consumer confidence in pharmaceutical products, enhance the competitiveness of local manufacturers in the global market, and ultimately contribute to advancing public health. This momentous decision by NAFDAC heralds a new era of elevated quality standards in pharmaceutical product registration, setting a precedent for regulatory excellence in the industry.
