Press release - European Pharmacopoeia Commission adopts monograph for Infliximab - December 2017
European Pharmacopoeia Commission adopts a new monograph for Infliximab concentrated solution ‒ the first monograph on a monoclonal antibody The European Pharmacopoeia (Ph. Eur.) Commission has achieved an important milestone in the field of biotherapeutic products at its 159th Session, held in Strasbourg on 21-22 November 2017, with the adoption of the monograph for Infliximab concentrated solution (2928).
Press release - Suppression Test Abnormal Toxicity Ph.Eur. - December 2017
During its 159th plenary session, held in Strasbourg on 21-22 November 2017, the European Pharmacopoeia Commission endorsed the complete suppression of the test for abnormal toxicity from the European Pharmacopoeia (Ph. Eur.).
Press Release - Convention against trafficking in human organs set to enter into force with Malta’s ratification - November 2017
The Council of Europe Convention against Trafficking in Human Organs will come into force after ratification by Malta on 07 November 2017. This is the fifth ratification, following those of Albania, Norway, the Republic of Moldova and the Czech Republic, and it triggers the Convention’s entry into force. These five ratifying member states will be bound by the Convention as of 01 March 2018.
Press Release - EDQM experts recommend further research on the safety of inks and tattoos - November 2017
The European Directorate for the Quality of Medicines & HealthCare (EDQM) today issued a compendium of the scientific information currently available on the potential toxicity of intradermal inks. This report, which was compiled by the EDQM’s Consumer Health Protection Committee and is aimed at risk evaluators and legislators across Europe, highlights potential harmful effects for many of the chemicals present in inks used for tattoos and permanent make-up (PMU).
Press Release - EDQM highlights importance of guiding Blood Establishments (BEs) in implementing quality standards - October 2017
26 October 2017, Strasbourg, France The EDQM has cast a light on the importance of supporting Blood Establishments (BEs) in implementing Quality Management (QM) elements such as risk management, change control and validation/qualification, as well as of delineating their practical implementation. This was the focus of a conference organised by the EDQM in Strasbourg from 17 to 19 October 2017 on Sharing best practices: quality risk management, change control, validation and qualification in BEs. As blood transfusion carries intrinsic and extrinsic risks, the implementation of Quality Management Systems (QMSs) is of the utmost importance to manage these risks and thus ensuring the safety and quality of human blood and blood components.
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.