2nd International Generic Drug Regulators Programme (IGDRP) – Active Substance Master File (ASMF)/Drug Master File (DMF) Working Group - Public statement


With a view to improving international cooperation and work-sharing in the assessment of ASMF/DMF for generic drugs, the members of the ASMF/DMF Working Group held a face to face meeting as part of the 2nd meeting of the International Generic Drug Regulators Programme (IGDRP) in Seoul, South Korea from 2-5 November 2015.

The ASMF/DMF working group met on 2 and 3 November 2015 with representatives attending from ANVISA, COFEPRIS , the European Directorate for the Quality of Medicines and Healthcare (EDQM), the European Union (EU), Health Canada, Health Sciences Authority (HSA), Ministry of Food and Drug Safety (MFDS), the Medicines Control Council (MCC), Pharmaceuticals and Medical Devices Agency (PMDA), Swissmedic, the Taiwan Food and Drug Administration (TFDA) , the Therapeutic Goods Administration (TGA), and the World Health Organization (WHO).

At this meeting, the working group provided an update on the progress of its several projects:

  • Common submission form, QAR template and the Lexicon of Quality terms have been completed and will be published on the IGDRP website soon.
  • Guidance for quality assessors was presented by HSA.
  • The draft for the survey results for proposed Criteria for filing a separate ASMF/DMF has been finalised.
  • Gap analysis has been completed and is ready for publication.
  • The working group updated its mandate.

A number of participating regulators shared information on new legislation and policies on ASMF/DMF. The challenges  to greater work sharing were discussed at length, international obligations, sharing of Confidential Business Information, Information technology, resources, regulatory and technical differences and stakeholder/industry engagement being some of them. The working group is now looking for possible solutions for these barriers/challenges. As such, the ASMF/DMF working group has expanded its scope to include stakeholder engagement and a repository of technical and regulatory issues of interest.

The next face to face meeting of the ASMF/DMF working group is scheduled to take place as part of the IGDRP meeting in Strasbourg, France from 9-10 May 2016.