The reflection paper, which was endorsed by the ICH Assembly on 13 November 2018, was released on 6 February 2019. The reflection paper outlines recommendations to develop a series of ICH guidelines on standards for demonstrating equivalence, e.g. bioequivalence, for (1) non-complex dosage forms and (2) more complex dosage forms and products. To accomplish this work, the ICH proposes that a generic drug discussion group be established to assist in assessing the feasibility of harmonization of standards for generics and to prioritize work areas.

ICH Reflection Paper: Further Opportunities for Harmonization of Standards for Generic Drugs
Date: 13 November 2018
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Reflection_Papers/ICH_ReflectionPaper_GenericDrugs_Final_2019_0130.pdf

The ICH says that ‘at present, a lack of harmonized standards reduces the number of potential markets in which data and information submitted in support of a generic drug marketing application can be used by a developer to support marketing authorization in another jurisdiction’. This, according to the ICH, can lead to monopolies in individual markets.

Harmonization, says the ICH, would prevent this from happening, and ‘may increase the size of generics markets and thereby attract more competition from developers, lower costs by increasing the number of market entrants, and expand patient access in jurisdictions in which developers otherwise may have decided not to pursue marketing authorization’.

The release of this reflection paper comes after the US Food and Drug Administration asked the ICH in November 2018 to advance the harmonization of scientific and technical standards for generics [1].

Related article
Generics group calls for say on ICH standards

Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA proposes standardization of generics standards [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Feb 15]. Available from: www.gabionline.net/Generics/General/FDA-proposes-standardization-of-generics-standards

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