The complexity of the US Food and Drug Administration’s (FDA) regulatory process for Drug Master Files (DMF) and the European Medicines Agency’s (EMA) Active Substance Master Files (ASMF) can be compellingly addressed by use of the electronic Common Technical Document (eCTD) format. However, the eCTD format is challenging to implement, with different regulatory requirements depending upon whether the target regulatory body is the FDA, EMA, individual country health authorities in the European Union or the European Directorate for the Quality of Medicines & Healthcare (EDQM).
The eCTD format was implemented in 2003 by FDA and the EU. It has been the required format for submissions to FDA’s Center for Drug Evaluation and Research since 1 January 2008 and for Centralised Procedure submissions to EMA since 1 January 2010.
This RAPS Webcast will describe the content of the DMF and ASMF for both the original manufacturer of drug substances, containers and excipients and for companies referencing DMF or ASMF submissions for the manufacturing of their drug products. It will describe how the regulatory differences of FDA, EMA and EDQM impact the content of DMF/ASMF in eCTD format. Finally, this webcast will describe how to produce DMFs and ASMFs in eCTD format including the business case for all sizes of companies.