The 1st International Generic Drug Regulators Programme (IGDRP) - ASMF/DMF Working Group - Public statement


The IGDRP ASMF/DMF working group was formed in May 2013 to foster international collaboration and worksharing in the area of evaluations for ASMFs/DMFs during the review of a generic drug product.

From the outset, this working group was provided with a mandate and scope to progress a number of overarching projects, including conducting the ASMF/DMF Gap Analysis Survey of technical requirements, procedures and systems, creating Common ASMF/DMF Quality Use Report (QAR) Templates and developing Common Guidance for Quality Assessors for the assessment of ASMFs/DMFs.

The ASMF/DMF working group met on 25 and 26 May 2015 in Pretoria, South Africa, with representatives from ANVISA, COFEPRIS, the European Union (EU), Health Canada, the Health Sciences Authority (HSA), the Medicines Control Council (MCC), the Ministry of Food and Drug Safety (MFDS), the Pharmaceuticals and Medical Devices Agency (PMDA), Swissmedic, the Taiwan Food and Drug Administration (TFDA) and the Therapeutic Goods Administration (TGA), as well as observers from the European Directorate for the Quality of Medicines and Healthcare (EDQM), and the World Health Organization (WHO).

This meeting was also attended by observers from the East African Community Medicines Regulatory Harmonisation initiative (EAC- MRH) and Southern African group of agencies (ZAZIBONA) who are involved in a similar regulatory harmonisation initiative.

At this meeting, the working group presented several successful project outcomes including: the ASMF/DMF common application form; the ASMF/DMF common quality assessment report template and the expansion of the ASMF/DMF lexicon of quality terms which was endorsed by the Steering Committee.

It is envisaged that the work done by the IGDRP ASMF/DMF working group will encourage a better understanding of each other’s evaluations for ASMFs/DMFs when reviewing a generic drug product; pave the way for closer collaboration among the participating drug regulatory authorities, particularly by contributing towards increased regulatory convergence; and improve international cooperation and work-sharing in the assessment of ASMF/DMF for generic drugs, but not limited to them.