By Biola Lawal
Abuja (Flowerbudnews): The National Agency for Food and Drug Administration and Control (NAFDAC) has initiated pre-dossier submission Parley with local pharmaceutical manufacturers to enhance their dossier packaging mechanism.
The Director-General of NAFDAC, Prof. Mojisola Christianah Adeyeye, who approved the new initiative, expressed optimism that the engagements would improve current submissions, and also served as valuable insights for future dossier preparations by the indigenous companies.
The engagement was being introduced ”to address the recurring issue of inadequate dossier submissions,” and was exclusively for local pharmaceutical manufacturers.
‘:Recognizing the need for continuous improvement in regulatory processes, this initiative aims to enhance the quality of Common Technical Document (CTD) dossiers, providing manufacturers with an opportunity to engage with the dossier review team,’: Prof Adeyeye stated.
The NAFDAC Boss said further that ”the virtual meetings will allow local pharmaceutical manufacturers to seek guidance, address queries, and clarify minimal requirements for CTD Dossier submission.
”This proactive approach intends to minimize the rejection of dossier applications on submission, fostering a more efficient registration process,”
She said that ” due to staff limitations, the meetings will be virtual and restricted to one application per product line per company.
”’Priority will be given to new companies lacking experience in the norms and standards for CTD dossier submission.”
Prof Adeyeye said that ”to facilitate effective discussions, applicants must submit the filled Quality Overall Summary (QOS) for the product at least one week before the scheduled pre-submission meeting, ensuring adequate preparation by the dossier review team”.
The Pre-Submission Meetings implementation will commence on January 2, 2024, Flowerbudnews reports.
