ICH Sets Out Proposals On Harmonizing Standards For Generics

07 Feb 2019

The ICH has published a reflection paper on harmonizing technical and scientific standards for generics that envisages initially developing guidelines on bioequivalence standards for non-complex oral dosage forms, followed by guidance on more complex dosage forms or products. A discussion group will also be established to identify opportunities to include generics in other ICH guidelines.

Singing — The ICH is seeking to harmonize generics standards • Source: Shutterstock

Globally-applicable guidance on bioequivalence standards for generics is being developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), according to a reflection paper just published by the organization.

Initial steps planned by the ICH as part of harmonization efforts on generics include guidelines on bioequivalence standards for non-complex...