Press Release - Pharmacopoeial discussion group achievements - October 2017
The meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph.Eur.), Japanese Pharmacopoeia (JP), and the United States Pharmacopoeia (USP)] was hosted by USP in Rockville, Maryland, U.S.A., September 12 – 13 2017.
Press Release - Ph. Eur. Microbiology Symposium - October 2017
20 October 2017, Strasbourg, France Microbiological control symposium: consensus on readiness of new methods emerges A symposium on microbiology in the pharmaceutical sector was the opportunity for the EDQM to gather feedback from users of the European Pharmacopoeia on alternative testing methods for microbiological control and sterilisation processes. The event, which took place in Strasbourg on 10-11 October 2017, was attended by a wide range of experts in the pharmaceutical and microbiological fields who reviewed the latest trends and innovations in the field of microbiology, in addition to Pharmacopoeial approaches and related regulatory requirements.
Press Release - EDQM discusses the place of its Certification procedure (CEPs) in the global regulatory environment - September 2017
The EDQM held a 2-day conference in Prague to exchange with the worldwide pharmaceutical sector and to keep authorities and manufacturers alike informed of recent developments and of the future of its Certification of suitability to the monographs of the European Pharmacopoeia in the global regulatory environment. The event was attended by 175 representatives of medicines authorities and manufacturers from all continents. As the world of pharmaceuticals is becoming ever more globalised, the EDQM’s certification procedure is becoming increasingly recognised and used beyond Europe.
Press release - Council of Europe reinforces transparency and safety of organ transplants carried out abroad - June 2017
The Committee of Ministers of the Council of Europe has recently adopted Resolution CM/Res(2017)2 on establishing procedures for the management of patients having received an organ transplant abroad upon return to their home country to receive follow-up.
Press Release - Council of Europe Member States set standards to ensure the protection and safety of non-resident living donors - June 2017
Council of Europe Member States set standards to ensure the protection and safety of non-resident living donors Many countries are developing and optimising living donor programmes either to complement the limited availability of organs from deceased donors or as the only source of organs while they develop deceased donor programmes. In the present globalised times, where people often travel and live abroad, many countries are accepting non-resident living donors.
Press Release - Outcome of the 158th Session of the European Pharmacopeia Commission - June 2017
The European Pharmacopoeia (Ph. Eur.) Commission adopted nine new monographs at its 158th Session, which took place in Strasbourg on 20 June 2017
Press release - Enhanced quality control of medicines within European Official Medicines - June 2017
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.
Press Release - Ph. Eur. consults on new quality standards for Live Biotherapeutic Products - April 2017
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.
Press Release - Test for Abnormal Toxicity: towards possible deletion from the European Pharmacopoeia - April 2017
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.
Press Release - 157th session Ph. Eur. Commission - March 2017
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.