Press Releases 2017 - Archive
Access all of the press releases published by the EDQM in 2017.
Press Release - EDQM rolls out reference standards for elemental impurities: lead, cadmium, mercury and arsenic - February 2018
The European Directorate for the Quality of Medicines and Healthcare (EDQM) announces the availability of four new elemental impurity chemical reference standards (CRS) in its European Pharmacopoeia catalogue: lead solution CRS, cadmium solution CRS, mercury solution CRS and arsenic solution CRS. These elements occurring in nature are amongst the greatest potential sources of elemental contamination in medicinal products and substances for pharmaceutical use; the new reference standards underpin the European Pharmacopoeia (Ph.Eur.) chapter describing the determination of elemental impurities (2.4.20).
Press Release - The Ph. Eur. revised its general chapters on plasticised PVC materials - January 2018
At its 159th Commission session (November 2017) the Ph. Eur. Commission adopted the following revised general chapters: • 18.104.22.168/90001. Materials based on plasticised poly(vinyl chloride) for containers for human blood and blood components; • 22.214.171.124/90002. Materials based on plasticised poly(vinyl chloride) for tubing used in sets for the transfusion of blood and blood components; • 3.2.4. Empty sterile containers of plasticised poly(vinyl chloride) for human blood and blood components; • 3.2.5. Sterile containers of plasticised poly(vinyl chloride) for human blood containing anticoagulant solution.
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.