Regulatory Requirements for Registration for Active Pharmaceutical Ingredients in Europe with Comparision to US

Abstract

Pharmaceutical products mainly depend on two basic constituent- Excipients and Active pharmaceutical ingredient (API). In order to regulate the API’s quality and development process a systematic documentation of API is required and this is where ASMF (Active Substance Master File), DMF (Drug Master File) plays the major role. DMF is compilation of confidential documents which are essential for the registration of API. Pharmaceutical manufacturer prepare the DMF and submit it to the appropriate regulatory authority. DMF filing is compulsory when there is need for two or more firms to come together and develop or manufacture a new drug. Although DMF provide same purposes across different regulatory authorities, they have different names and specifications. In Europe it is known as a European Drug Master File (EDMF) or Active Substance Master File (ASMF) and in United States it is known as a USDMF. DMF is made up of Applicant Part and Restricted Part. Applicant part gives non-confidential information which is only disclosed to the license holder and restricted part gives confidential information which is only disclosed to the authorities. This dissertation work includes the DMF preparation and submission requirements and procedures for Europe along with, a brief comparative overview of current API registration requirements across Europe & US.