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FDA proposes standardization of generics standards Posted 02/11/2018

The US Food and Drug Administration (FDA) announced on 18 October 2018 that it has proposed to the International Council on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to advance the harmonization of scientific and technical standards for generics.

This new effort comes as part of the US Government’s strategy to reduce drug prices by increasing competition. As part of this strategy, FDA launched a Drug Competition Action Plan in June 2017 [1]. Although FDA Commissioner Scott Gottlieb stated in June 2017, that ‘FDA doesn’t have a direct role in drug pricing’, he added that ‘we can take steps to help address this problem by facilitating increased competition in the market for prescription drugs through the approval of lower-cost, generic medicines’.

Dr Gottlieb announced that the Drug Competition Action Plan would be relaunched in 2019 with some additional initiatives, including the proposal to ICH. The idea is straightforward’, stated Dr Gottlieb. The plan is to enable generics developers to ‘implement a single global drug development program and utilize common elements of applications to file for approval in multiple markets’.

FDA believes this will make it easier for generics developers to also gain approval in the US and likewise would also encourage developers who would normally only seek approval in the US to gain access to other markets. This is expected to increase market competition and ultimately reduce drug prices.

FDA has therefore proposed that ICH develop a series of guidelines on standards for demonstrating equivalence, e.g. bioequivalence, for both non-complex and complex dosage forms and drug products. The agency expects that ICH will review its proposal and that the ICH Assembly will be invited to endorse the proposal at its next meeting in November 2018.

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1.  GaBI Online - Generics and Biosimilars Initiative. FDA lists drugs without generics to increase competition [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 2]. Available from: www.gabionline.net/Generics/General/FDA-lists-drugs-without-generics-to-increase-competition

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Source: US FDA

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