IGBA Wants A Harmonized And Streamlined Global Framework
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.
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Industry veteran Suzette Kox has been nominated as secretary general of the International Generic and Biosimilar medicines Association.
Planned regulatory reforms in Australia would align requirements for generic applications to global standards as well as incentivize filings for complex 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.