News

Overviews of all the latest meetings held by IGDRP are available here. For a list of recent documents published by IGDRP, see the Documents page.

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

News

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.

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1st Meeting of the International Generic Drug Regulators Programme, Pretoria, 27-28 May 2015

News

The International Generic Drug Regulators Programme (IGDRP) was formed following progression from its 3-year Pilot phase and continues to promote collaboration and convergence in generic drug regulatory programs in order to address the challenges posed by increasing workloads and complexity of scientific issues.

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