Bioequivalence

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

News

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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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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Results of Singapore meeting, 2-5 November 2014

Archived

Following on from its sixth meeting in May 2014 in Yilan, Taiwan, representatives from the regulatory authorities of Australia, Brazil, Canada, Chinese Taipei, Japan, the Republic of Korea, Singapore, South Africa, Switzerland as well as representatives from the European Directorate for the Quality of Medicines and Healthcare (EDQM), European Union and the World Health Organization met in Singapore.

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