On February 6, 2019, the ICH (International Council for Harmonization) published a new reflection paper on "Further Opportunities for Harmonization of Standards for Generic Drugs". According to ICH, the document outlines a "strategic approach for developing and enhancing ICH Guidelines to support the harmonization of scientific and technical standards for generic drugs". As part of this approach, recommendations are provided to develop a series of ICH Guidelines. These guidelines will include tools for demonstrating equivalence (e.g., bioequivalence) for non-complex dosage forms and more complex dosage forms and products.
A generic drug product usually contains a small molecule active pharmaceutical ingredient (API). An applicant can obtain market access by demonstrating equivalence to an already marketed reference product by providing appropriate data to demonstrate safety and efficacy. Individual drug regulatory authorities may differ in the scope of this type of approval and may have different regulatory definitions of a generic drug. Furthermore, legal and regulatory requirements for generic drugs are sometimes not aligned. For example:
According to ICH, it is therefore proposed to "develop and enhance ICH guidelines in scientific and technical areas that would be valuable and achievable across multiple regulatory pathways and where there is common interest in harmonization". Annex I of the reflection paper identifies existing ICH Guidelines that might be revised to include recommendations for generic drugs.
The following ICH Efficacy guidelines might be revised to include recommendations on:
More information can be found in ICH´s new reflection paper on "Further Opportunities for Harmonization of Standards for Generic Drugs".