Press Release - Update on the Ph. Eur. Policy on Elemental Impurities - January 2017
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.).
Press Release - New chapter Ph. Eur. on Chemical Imaging- January 2017
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.
Press Release - Ph. Eur. Commission Pilot phase biotherapeutics under patent - December 2016
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.
Press release - Ph.Eur. Commission Session 3Rs - November 2016
In accordance with the European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes, the Ph. Eur. Commission is committed to the reduction of animal usage wherever possible in pharmacopoeial testing, and encourages those associated with its work to seek alternative procedures.
Press release - European Pharmacopoeia Commission - November 2016
At its 156th session, the European Pharmacopoeia Commission approved the priorities for the three coming years, which are aimed at maintaining the scientific excellence, leading role and influence of the Ph. Eur. worldwide.
Press release - Pharmacopoeial discussion group achievements - October 2016
The meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), and United States Pharmacopeia (USP)] was hosted by JP in Tokyo, Japan, 24-26 October 2016.
Press release - Ph. Eur. Conference Tallinn - September 2016
International conference: “European Pharmacopoeia: Tackling future challenges of the Quality of Medicines together”, 27-28 September 2016, Tallinn, Estonia
Press Release - Ph. Eur. Commission 155th session - June 2016
Following the election of its Chair, Dr Tobias Gosdschan, in its March session, the European Pharmacopoeia (Ph. Eur.) Commission elected Prof. Torbjörn Arvidsson (Sweden) and Dr Hilda Köszegi Szalai (Hungary) as its first and second Vice-chair,
Press Release - Ph. Eur. Commission 155th session MAT - June 2016
Ph. Eur. Commission adopts revised general chapter on monocyte activation test to facilitate reduction in animal testing During its 155th Session, held in Strasbourg on 21-22 June 2016, the European Pharmacopoeia Commission adopted a revision of the general chapter Monocyte-activation test (2.6.30) in order to make it more widely useable by stakeholders and thus facilitate a reduction in testing on live animals.
Press release - EDQM International Symposium on the challenges of quality requirements for fish vaccines - May 2016
As part of the ongoing efforts of the European Pharmacopoeia Commission to replace in vivo with in vitro methods and its significant efforts to reduce the number of animals used to test vaccines, a symposium directed towards fish vaccine manufacturers, regulatory authorities and academia has taken place at the Norwegian University of Life Sciences in Oslo.