By Biola Lawal
Abuja”(Flowerbudnews): NAFDAC Director General, Prof Mojisola Adeyeye has directed that Bioequivalence (BE) data become mandatory part of product registration dossier with effect from January 2025.
Announcing the measure through an information output by NAFDAC News on Wednesday in Abuja, Prof Adeyeye said that the new measure would ensure better guarantee of safety and efficacy of medicines being marketed in Nigeria.
Prof. Adeyeye said that the mandatory inclusion of Bioequivalence (BE) data in dossier submissions for generics and non-innovator multiple source drug products would show that the medicines met the “”same standards as innovator products as a basis for clinical interchangeability”.
The NAFDAC Boss disclosed that the directive followed ”extensive discussions with manufacturers and other stakeholders, emphasising the importance of BE studies for generic products seeking marketing authorisation approval”
She noted that the move further reflected NAFDAC’s commitment ‘:to continuously improve and enhance regulatory systems, to ensure rigorous evaluation of multisource pharmaceuticals prior to registration to guarantee safety and efficacy”.
Prof Adeyeye urged Stakeholders and international partners to take note of the new directive for strict compliance.(Flowerbudnews)
