6 February 2019

The ICH Reflection Paper on Further Opportunities for Harmonization of Standards for Generic Drugs was endorsed by the ICH Assembly in November 2018.

Harmonization of technical and scientific standards for generic drugs presents an opportunity for significant public health benefits by streamlining drug development across regulatory jurisdictions and increasing patient access globally to high quality affordable pharmaceuticals. This ICH Reflection Paper outlines a strategic approach for developing and enhancing ICH Guidelines to support the harmonization of scientific and technical standards for generic drugs.

This ICH Reflection Paper furthermore describes the remit of the Informal Generic drug Discussion Group (IGDG). The IGDG is to be established by ICH in 2019 and will serve as a technical discussion group for issues relevant to harmonisation of scientific and technical standards for generic drugs. The IGDG will recommend areas for harmonisation under ICH and assess feasibility of harmonisation of various topic areas within existing regional regulatory frameworks.

More information can be found on the Reflection Papers page.