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Ph. Eur. consults on new quality standards for Live Biotherapeutic Products

06/04/2017 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) is consulting the public on three new texts, which for the first time in Europe, propose harmonised quality standards for Live Biotherapeutic Products (LBPs) used in human healthcare.

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Test for Abnormal Toxicity: towards possible deletion from the European Pharmacopoeia

03/04/2017 Strasbourg, France

The European Pharmacopoeia Commission is seeking public feedback on its proposal to remove the requirements for a test for abnormal toxicity from 49 monographs of the European Pharmacopoeia (Ph. Eur.). Published in the Pharmeuropa issue of April 20171 , this consultation will run until June...

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Outcome of the 157th Session of the European Pharmacopeia Commission

30/03/2017 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission adopted 15 new monographs at its 157th Session, which took place in Strasbourg on 21-22 March

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Falsified medicines in Europe: enhanced analytical capacity for national laboratories through the OMCL Network

29/03/2017 Nicosia, Cyprus

The European network of Official Medicines Control Laboratories has highlighted how new analytical techniques will support national authorities, such as health government agencies, customs, police and courts, in the fight against falsified medicines in Europe and globally. Discussions took...

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Update on the Ph. Eur. Policy on Elemental Impurities

11/01/2017 Strasbourg, France

With the implementation of the ICH Q3D guideline on elemental impurities, the control of elemental impurities is undergoing a shift in paradigm, moving away from pure substance-based testing towards a holistic control strategy in the finished product. 

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