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05

Mar

EDQM clarifies implications of new sartan monographs - Revision of CEPs

The European Directorate for the Quality of Medicines (EDQM) has explained the implications of new sartan monographs for the holders of a currently valid Certification of Suitability (CEP).

Last month, EDQM said monographs for five sartan medicines, which were rapidly revised considering the risk of contamination with N-nitrosamines, will take effect 1 April. However, EDQM’s February update lacked details of how the revised monographs will affect suppliers of valsartan, losartan potassium, irbesartan, candesartan cilexetil and olmesartan medoxomil.

EDQM shared more information this week, stating that “it is considered that the currently valid CEPs referring to these monographs are already in conformity with the requirements of the monographs and therefore remain valid.”

While there is no need for CEP holders to demonstrate conformity to the monographs, EDQM said they may choose to revise their control strategies for nitrosamine impurities in light of the updated information. CEP holders that change their strategies should request a minor revision....[EDQM]

22

Apr

Update on the Ph. Eur. policy on elemental impurities – Monographs on substances for veterinary use only

he European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its proposal to delete...

20

Apr

US GDUFA III: Use MDUFA model to create competition in generic drug markets

To design an effective financing system for generic drug approvals, the FDA must balance the need...

20

Apr

Pharmaceutical reshoring: a strategic necessity

More than a year into the COVID-19 crisis, the novel coronavirus continues to disrupt our societies,...

19

Apr

Covid-19 ministro Speranza firma nuove Ordinanze per contenere la diffusione del virus

Il Ministro della Salute, Roberto Speranza, sulla base dei dati e delle indicazioni...

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