Drug Master File Procedures in the EU, the US and Japan

Drug Master File Procedures in the EU, the US and Japan

Berlin, Germany

Course No 16662


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Marieke van Dalen, Aspen Oss B.V, The Netherlands

Dr Hiltrud Horn, Horn Pharmaceutical Consulting, Germany

Dr Usfeya A Muazzam, Bonn, Germany

Dr Boris Pimentel, Antibioticos de León, Spain

Dr Wilhelm Schlumbohm, Berlin, Germany


This education course is intended to provide guidance on the procedures for the European ASMF, the US-DMF and the Japanese DMF. You will get to know

  • how to describe manufacturing processes
  • how to compile data for drug substance stability, impurities and residual solvents
  • which are the important points to consider for US-DMFs
  • which are the requirements for Japanese DMFs
  • how to handle changes in European, US and Japanese DMFs
Participants will have the opportunity to take part in one of two parallel workshops about
Description of the manufacturing process or How to compile data for Impurities and Residual Solvents


Documentation of the drug substance quality is an integral part of any marketing authorisation application. In Europe the most common document for this purpose is the Active Substance Master File (ASMF) as long as the applicant has no Certificate of Suitability of the pharmacopoeial monograph (CEP). The European ASMF procedure differs significantly from the US-DMF procedure and for strategic reasons it is very important to take these differences into account. Moreover there are particular requirements for DMFs in Japan. For global acting companies it is a big challenge to handle the different procedures of compiling, submitting, changing and maintaining Drug Master Files in an efficient way.

Target Group

The education course is designed for all persons involved in the compilation of pharmaceutical dossiers for marketing authorisations especially for Drug Master Files who want to become familiar with the different DMF procedures. Furthermore, the course will be of interest to personnel from Quality Units of the pharmaceutical and the API industry.


The European Active Substance Master File procedure – An Introduction

  • Chemical pharmaceutical documentation for active substance(s) –
  • Regulatory requirements in EU, USA
  • Types of active substances – types of documentation
  • CTD Module 3, CEP and ASMF (former DMF)
  • CEP for a substance for TSE risk assessment
Drug Master File Procedures in the US
  • Types of Drug Master Files
  • Submissions to DMFs
  • Closure of a DMF
  • US vs EU DMF – differences in the procedure
How to document drug substance stability
  • Stability Guidelines
  • Stability Testing of new drug substances and drug products
  • Storage Conditions
  • Bracketing and Matrixing Designs
  • Stability data from new drug dosage forms
  • How to document evaluation of stability data
  • Optimising the submission
Residual solvents and Impurities: synthesis derived Impurities, Metals and genotoxic Impurities
  • Guidelines
  • Impact of the new guidelines ICH Q3D and ICH M7
  • Sources of Impurities
  • Setting and justification of specifications
  • Residual solvents, solvent classes
  • Content and scope of data – documentation requirements
  • Frequent mistakes
Post Approval Changes in the US
  • Post approval activities
  • Reporting requirements to the FDA (CBE 0, CBE 30, Annual Report)
  • Post approval commitments and post approval reporting requirements
  • Risk evaluation and mitigation strategies (REMS)
Handling Changes in European Drug Master Files
  • Why is there a need for changes
  • Types of changes
  • How to communicate with the MA holders and how to get feed back
  • Differences between ASMF and CEP
  • When to implement a specific change
  • Version management of the ASMF
Requirements of the Drug Master File Procedure in Japan
  • Regulatory procedures in Japan:
  • Site accreditation | GMP paper-based inspection | Drug Master File
  • Drug Master File format
  • Specific points to consider for the J-DMF
  • Communication with the Japanese authorities
Changes and Maintenance of Japanese Drug Master Files
  • Change procedures and communication with the Japanese authority
  • Types of changes
  • Notification of changes
  • Comparison of the CEP and ASMF Procedure
  • The certification scheme of the PhEur
  • Advantages and disadvantages of the CEP procedure compared to the ASMF procedure
  • Handling of variations in the CEP procedure
  • Countries accepting CEPs
Parallel Workshops
Please choose one out of two Parallel Workshops:
  • Description of the Active Substance manufacturing process
  • Managing changes in Drug Master Files -Case Studies-

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