Joining ICH committee is ‘milestone’ for IGBA
Global generics and biosimilars industry representatives have celebrated a “historical moment for our industry” after the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) elected the International Generic and Biosimilar Medicines Association (IGBA) as a member of its management committee.
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For the first time, a working group within the International Council for Harmonization has started work on a regulatory topic specifically tailored to the global generics and biosimilars industry.
In the first of three exclusive interviews with IGBA secretary general Suzette Kox and chair Jim Keon, Kox provides the latest update on global regulatory harmonization efforts.
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.