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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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New chapter Ph. Eur. on Chemical Imaging

05/01/2017 Strasbourg, France

The chapter on Chemical Imaging (5.24) was adopted by the European Pharmacopoeia Commission at the end of November 2016. The Vibrational Spectroscopy and Analytical Data Modelling working party (VSADM) has produced the first such chapter to be included in any pharmacopoeia worldwide.

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The Ph. Eur. Commission concludes its pilot phase for monographs for biotherapeutics still under patent

14/12/2016 Strasbourg, France

Since the approval of the first biological produced by recombinant DNA (rDNA) technology, recombinant human insulin, numerous biotherapeutics have received regulatory approval in Europe. European Pharmacopoeia (Ph. Eur.) monographs have been elaborated for many of these firstgeneration...

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The European Pharmacopoeia Commission adopts the monograph on sodium pertechnetate (99mTc) (Accelerator-produced) injection (2891)

02/12/2016 Strasbourg, France

At its 156th Session the European Pharmacopoeia Commission adopted the monograph on Sodium pertechnetate (99mTc) (accelerator-produced) injection (2891).

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