public statement

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

News

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.

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

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The IGDRP Biowaivers working group was formed in May 2013 with the objective of establishing a common set of conditions for the granting of biowaivers as well as the expansion of the application of waivers. From the outset, this working group was provided with a scope and workplan to progress work on the use of Biopharmaceutical Classification System (BCS)-based biowaivers, biowaiver for additional or non-biostudy strengths of a solid dosage form product line, and biowaivers for certain dosage forms, e.g. solutions for parenteral, oral or local use .

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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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