Notice on New Window for Dossier Submissions
This is to inform all stakeholders that the window for submission of new product dossiers will open on 29th April 2024. This submission will be on the NAFDAC Dossier Management System (DMS) Version 2. All applicants who intend to submit dossiers during this window should note the following. New applicants will need to create their […]
Sources of API’s and Excipients
QUALITY OF ACTIVE PHARMACEUTICAL INGREDIENTS (APIs) 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 […]
Introduction of “Pre-Submission Meetings” for Submission of CTD Dossiers for Locally Manufactured Pharmaceutical Products.
The management of NAFDAC has noticed with dismay the high number of dossier applications that do not meet minimal requirements for submission of CTD dossiers. As part of its continuous improvement efforts and strengthening of its regulatory systems, NAFDAC is introducing a ‘pre-submission meeting’ applicable only to local pharmaceutical manufacturers to enhance the quality of […]
