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  1. Press release - Enhanced quality control of medicines within European Official Medicines - June 2017

    English

    2017 meeting of Official Medicines Control Laboratories (OMCLs) emphasised work sharing and information exchange for the benefit of public health. Participants were also introduced to the European Commission’s Vaccine to Vaccine project (VAC2VAC), for promoting the reduction of animal use in testing the safety of vaccines.

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

    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.

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

    English

    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.

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

    English

    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 2017, this consultation will run until June 2017 for all users, and will be extended until August for National Pharmacopoeia Authorities. Interested parties are invited to provide their comments through the Procedure for commenting on Pharmeuropa drafts.

  5. EDQM Press Release PhEur Comm 157th session March 2017

    English

    Outcome of the 157th Session of the European Pharmacopeia Commission The European Pharmacopoeia (Ph. Eur.) Commission adopted 15 new monographs at its 157th Session, which took place in Strasbourg on 18-19 March. Other adopted texts included 47 revisions, of which 37 on monographs and 10 on general chapters; all were aimed at keeping the Ph. Eur. content updated and in line with regulatory developments and scientific state of the art. To date, the Ph. Eur. has been updated with 183 new or revised texts since the release of the Edition 9.0 last year.

  6. Press release - EDQM Counterfeit Symposium Nicosia Cyprus - March 2017

    English

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

  7. Archive Press Releases 2016

    Read all of the press releases published by the EDQM in 2016.

  8. Press Release - Update on the Ph. Eur. Policy on Elemental Impurities - January 2017

    English

    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. While these approaches are not contradictory, this change has triggered the revision of numerous texts in the European Pharmacopoeia (Ph. Eur.).

  9. Press Release - New chapter Ph. Eur. on Chemical Imaging- January 2017

    English

    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.

  10. Press Release - Ph. Eur. Commission Pilot phase biotherapeutics under patent - December 2016

    English

    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 first-generation biotherapeutics (including peptide hormones, growth factors, interferons) using the multisource approach and have led to robust quality standards.

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