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Pharmexcil urges cos to adhere to strict quality control measures for APIs and excipients exported to Nigerian market
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Shardul Nautiyal, Mumbai
February 19 , 2024
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In a move aimed at bolstering pharmaceutical safety and efficacy standards, the Pharmaceutical Export Promotion Council of India (Pharmexcil) has urged pharmaceutical exporting companies to adhere to strict quality control measures for active pharmaceutical ingredients (APIs) and excipients exported to Nigerian market.
The National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria, has issued a notification outlining stringent criteria for the quality of APIs used in the manufacture of finished pharmaceutical products (FPPs) in the Nigerian market.
The notification, effective from January 2024, mandates that all APIs supplied for the production of FPPs must meet specific criteria to ensure their safety and efficacy. Only applications for product registration supported by APIs or FPPs sourced from approved entities will be accepted for review by NAFDAC.
The approved sources include WHO Prequalified APIs, APIs possessing certificates of suitability to the monographs of the European Pharmacopoeia (CEP), APIs and FPPs obtained from facilities certified by PIC/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.
Pharmaceutical companies and manufacturers have been urged to prioritize sourcing APIs from reputable suppliers while adhering to stringent quality control measures to ensure the highest standards in their products. Additionally, all excipients used in the manufacture of finished pharmaceutical products must be of pharmacopoeia grade and sourced from ISO-9001:2015 or EXCiPACT-certified facilities.
Companies holding registered FPPs, which have not procured their APIs or excipients from the approved sources, are required to provide evidence by January 2027 of a transition to an alternate manufacturer that complies with the stipulated criteria. This evidence must be submitted to NAFDAC as a variation or post-approval change before the end of January 2027.
The notification underscores NAFDAC's commitment to ensuring the safety, efficacy, and quality of pharmaceutical products available in the Nigerian market. By aligning with international standards and best practices, NAFDAC aims to enhance public health and consumer confidence in pharmaceutical products.
Industry stakeholders have welcomed the notification, acknowledging its role in promoting transparency and accountability in the pharmaceutical supply chain. They have pledged their commitment to complying with the new guidelines and working collaboratively with NAFDAC to uphold the highest standards of quality and safety in the Nigerian pharmaceutical sector.
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