• Feature ArticlesFeature Articles

    Worksharing in the Evaluation of Active Substances

    This article describes ongoing procedures and initiatives for 'worksharing' in the evaluation of active substance dossiers by regulatory authorities around the world. Introduction An Active Substance or Drug Master File (ASMF/DMF) can be used to describe the chemistry, manufacture and controls for an active substance. It is typically divided into an applicant's or open part and a restricted or closed part. The applicant's part is provided to the Marketing Authorizatio...
  • EMA Releases Updated Final Guideline on Active Substance Master Files

    A new final guideline published on 13 July 2012 by the European medicines Agency (EMA) updated the Active Substance Master File (ASMF) Procedure -its first upgrade since its formation in 2006. The ASMF procedure, formerly known as the European Drug Master File (EDMF) procedure, is used to protect confidential intellectual property information while allowing regulatory agencies to access a more complete picture regarding how an active substance is manufactured. Both EMA a...
  • EMA Releases New Guideline on Active Substance Master File Procedure

    The European Medicines Agency released its Guideline on Active Substance Master File (ASMF) Procedure yesterday that aims to improve the ASMF procedure across the European Regulatory Network by having a unique version of an ASMF for one active substance valid for the whole European Union (EU) and European Economic Area (EEA). One assessment report (AR) of an ASMF can be recognized by all Competent Authorities (CAs), thereby improving a product's time to market. The p...