Pharmaceuticals 2011 - Construction of the European Drug Master File (EDMF) for Regulatory Agencies

This webinar will cover a step-by-step process to construct and submit the European Drug Master File (EDMF), recordkeeping requirements and manufacturer responsibilities.

Drug master files serve as documentation on the quality of an active ingredient or excipient and are submitted by a manufacturer as part of the licensing or amendment procedure. The DMF should be submitted in the format described in the Common Technical Document (CTD) Part 3.2.S.

This Webinar will focus on the European Community procedure where information can be provided to the authorities and the applicant, where the active substance manufacturer is not the applicant for a product marketing authorization, with a view to protecting valuable manufacturing know-how. This session will use the words “medicinal products” and these cover both products for use in humans and veterinary products. This Webinar will focus on the European, not FDA’s DMF or Master File.