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04

Mag

EDQM - Tentative policy on assay RSDs for monographs on medicinal products containing chemically defined active substances

When the experimental results allow, draft monographs will be published in Pharmeuropa with a peak area repeatability requirement of RSD ≤ 1.0% (n=6) determined on a solution containing the active substance CRS.

A trial period for this policy will run until the end of February 2022; any comments received during the Pharmeuropa public enquiry will be assessed and the policy will be amended or confirmed as appropriate...[EDQM]

06

Mag

EDQM - New policy for the development of monographs on medicinal products containing chemically defined active substance salts or bases/acids

At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission approved a new...

05

Mag

EU Draft report on a pharmaceutical strategy for Europe

Draft report on a pharmaceutical strategy for Europe [2021/2013(INI) – Rev. 26 aprile...

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