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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 policy for the development of monographs on medicinal products containing chemically defined API salts and/or API (base/acid).
Separate individual monographs on medicinal products will be developed for each API salt/API base or acid when different approved medicinal products contain the same active moiety but not the same salt form.......[EDQM]

07

Giu

EU Regulators On Forecasting Demand For Medicines In A Pandemic

EMA - Reflection paper on forecasting demand for medicinal products in the EU/EEA             ...

07

Giu

Svolta nel mercato dei farmaci in Cina, aziende straniere più tutelate

La riforma dei brevetti e l’introduzione di un nuovo regolamento sui dispositivi medicali fanno...

26

Mag

TGA Australia guidance details management of GMP compliance signals

Australia’s Therapeutic Goods Administration (TGA) has published guidance on the management...

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