MITIGATING SUBSTANDARD MEDICINES:
ENSURING QUALITY OF ACTIVE PHARMACEUTICAL INGREDIENTS (APIs) AND EXCIPIENTS USED IN THE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCTS (FPPs) FOR THE NIGERIAN MARKET
The quality of Active Pharmaceutical Ingredients (APIs) used in Finished Pharmaceutical Products (FPPs) manufacturing directly impacts the safety, efficacy, quality, regulatory compliance, consistency, supply chain, reputation, and cost-effectiveness of pharmaceutical products. Pharmaceutical companies and manufacturers must prioritize sourcing APIs from reputable suppliers while adhering to stringent quality control measures to ensure the highest standards in their products.
To this end, NAFDAC wishes to inform all stakeholders intending to submit dossiers for product registration starting from 2025, that only applications supported by APIs or FPPs sourced from any of the underlisted approved sources will be accepted for review. These are:
- WHO Prequalified APIs https://extranet.who.int/prequal/medicines/prequalified/active-pharmaceutical-ingredients
- APIs with certificates of suitability to the monographs of the European Pharmacopeial (CEP)
- APIs and FPPs sourced from facilities certified by PIC/s participating authorities
https://picscheme.org/en/members
- APIs sourced from facilities certified by Stringent Regulatory Authorities (SRA) or WHO Listed Authorities (WLA) https://extranet.who.int/prequal/medicines/prequalified/active-pharmaceutical-ingredients
- APIs certified by accredited ISO-17025: 2017 accredited 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. EXCiPACT-certified sources is shown below. https://www.excipact.org/certificate-holders.html
List of high-risk excipients and safety information can be found at the link below:
https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/current projects/qas24_944_excipients_appendix2_forpublic.pdf?sfvrsn=da3af923_2
Companies with registered FPPs who have not sourced their APIs or Excipients from any of the listed sources, must provide evidence by January 2027 of a change of source to another manufacturer that satisfies any of the above listed sources. The evidence must be submitted to the agency as a variation or post-approval change before the last day of January 2027. This directive takes immediate effect and please note that failure to comply will attract stiff penalties.
Thank you.
Prof. Mojisola Christianah Adeyeye, FAS
Director General – NAFDAC
