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[Helmut Schütz]

For all of you dealing with BE of IR products:

 

The International Council for Harmonisation finalized its guideline M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms on July 23, 2024. It is accompanied by a Q&A document. The implementation of the guideline will take some time. There is no deadline and no obligation for an agency to implement it at all. However, it is expected to supersede current guidelines at least in the major jurisdictions (FDA, EMA).

 

For some differences to the draft guideline (December 20, 2022) see this thread in the BEBA-Forum.

[Helmut Schütz]

On 25 July 2024 the guideline was published by the EMA and will come into effect on 25 January 2025.

 

The FDA’s guidance was published on 30 October 2024. The FDA updated also 814 Product-Specific Guidances (list). For the majority (≈85%) of PSGs the recommendation of performing the studies in fed condition was removed. For two products (pimavanserin tartrate, tablet and capsule), a BCS-based biowaiver was added as an option. For the others the recommendation of performing the studies in fasting condition was removed.