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.
ICH Sets Out Proposals On Harmonizing Standards For Generics
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.
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