TRAINING ON QUALITY DOSSIER AND BIOEQUIVALENCE REQUIREMENTS A KEY TO EFFECTIVE REGULATORY FILLINGS

The Food and Drugs Authority (FDA) on Monday, 12th September 2022 at the Noble International Business School (NiBS), Accra started a two-day training for pharmaceutical manufacturers and importers on the Quality Aspect of Dossier and Bioequivalence requirement for regulatory filings for Regulatory Affairs and Quality Assurance Managers in the Pharmaceutical supply chain.

Mr. Seth Seaneke, the Deputy- CEO, who represented the CEO, Mrs. Delese Darko, in the opening remarks indicated that this training forms part of efforts pursuant to goal 3.8 of the Sustainable Development Goals (SDG) of the United Nations which includes universal health coverage including financial risk protection, access to quality essential health-care services and access to safe, effective, quality, and affordable essential medicines and vaccines for all. According to him, safe, effective, quality and affordable essential medicines cannot be achieved if dossier and bioequivalence requirements for regulatory filings for these pharmaceutical products are not properly done for the issuance of market authorization.

In view of this, Mr. Seaneke reiterated the need to build the capacity of manufacturers and importers of medicines on bioequivalence requirements and the preparation and submission of dossiers for registration and approval processes. Some of the challenges identified include the control of impurities for the active pharmaceutical ingredient (API) and the finished pharmaceutical products (FPP), polymorphism and particle size characterization, dissolution limits and reporting.

To address these deficiencies in dossier filings, the FDA organised the training for both local manufacturers and importers of pharmaceutical products to bring them up to speed on the quality aspects of the dossier and Bioequivalence requirements.

Mr Samuel Asante-Boateng, Director, Drugs and Herbal Medicines Registration Directorate at the FDA, in his introduction also intimated that, the objective of this training was to further improve the quality of regulatory filings for the grant of marketing authorization for pharmaceutical products and hopes the knowledge gained through this training will facilitate the reduction of timelines for processing of applications, thereby making available quality, safe and affordable medicines to the Ghanaian.

Sharing expectations from the training, Mr Agyenim-Boateng, a participant, expressed hope that this training will equip him to be able to submit proper requirements to facilitate all his product registration needs.