IGDRP generic drug product regulatory gap analysis - Regulatory collaboration (WHO Drug Information Vol. 30, No. 3, 2016)
(2016; 9 pages)


The International Generic Drug Regulators Pilot (IGDRP) was launched in 2012 as an international collaborative initiative for information- and work-sharing activities for the regulation and registration of generic drug products. Initially operating as a three-year pilot (2011–2014) the IGDRP was renamed a Programme in 2014, recognizing the progress achieved during the pilot phase, the strong commitment from regulators and their continued interest and need to cooperate to facilitate the timely authorization and availability of safe, effective and high quality generic drug products.

A regulatory gap analysis survey was conducted to identify regulatory similarities amongst the IGDRP members as well as gaps that might create challenges for work-sharing and collaboration. The WHO Prequalification Team, the European Union (EU) and eleven regulatory authorities participated in the survey. The main gaps observed were: the definition of a generic drug product and what is considered to be the same active (or drug) substance; whether and when international reference products can be used in bioequivalence studies; the criteria for granting biowaivers; requirements to use national or regional pharmacopoeias; and the minimum stability data to be included in a generic drug product application at the time of submission.

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