Last week’s round -up;
06 -13 November 2020

published 16 Nov 2020

New EMA product-specific bioequivalence guidance

The EMA has released the following updated product-specific bioequivalence guidance: • A new draft guidance for Acenocoumarol 1 mg and 4 mg tablets. This draft guidance is open for public consultation until the 28th February 2021. • Revised guidance for Dasatinib 20, 50, 70, 80, 100 & 140 mg film-coated tablets and 10 mg/ml suspension, which comes into effect on the 1st May 2021. This product-specific bioequivalence guidance was updated to include the additional requirement for a fed study and the requirements for the suspension.

Pharmeuropa 32.4 – Revised draft monographs for substances with a CEP

Twelve revised Ph. Eur. monographs for substances with a CEP have been published in Pharmeuropa 32.4. CEP holders are requested to consult the list of draft monographs and submit their comments on these draft monographs by the 31st December 2020. Users are also encouraged to review the draft monographs to ensure that their drug substances still comply with the revised drafts.

A list of the revised draft monographs may be viewed at the following link:

Search Real Regulatory