Press Release - EDQM welcomes WHO recommendation to discontinue innocuity test - December 2018
The EDQM has welcomed the recommendation of the WHO Expert Committee on Biological Standardization (ECBS) to omit the abnormal toxicity test (also called the innocuity test) in all future WHO documents on vaccines and other biological products, and to disregard the inclusion of this test in previously published WHO Technical Report Series documents.
Press Release - Outcome of the 162nd Session of the European Pharmacopoeia Commission - November 2018
At its 162nd Session in Strasbourg on 20-21 November 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 16 new texts.
Press Release - Ph. Eur. Modification General Section 3 - November 2018
The European Pharmacopeia (Ph. Eur.) includes a Section 3. on materials for containers (Subsection 3.1) and containers (Subsection 3.2). For historical reasons, the general chapters of this Section 3. include texts on primary packaging, as well as on medical devices.
Press Release - Public Consultation for Ph. Eur. dosage form monograph on Parenteral preparations (0520) and new informative chapter on testing for visible particles (5.17.2) - November 2018
The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on two major texts for the testing of parenteral drug products. The pivotal dosage form monograph Parenteral preparations (0520) prescribes the mandatory requirements and tests for preparations intended for injection, infusion or implantation. The monograph has been modernised to meet current testing requirements e.g. for (sub-)visible particles, bacterial endotoxins, uniformity and release, particularly as applied to liquid parenteral preparations.
Press Release 27 2018 - Pharmacopoeial discussion group achievements - October 2018
The face-to-face meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP)] was hosted by the EDQM in Strasbourg, France, on 2-3 October 2018. WHO participated as Observer. Sign-offs at this meeting included a new monograph on Copovidone and revisions to monographs on Microcrystalline Cellulose, Wheat starch and Gelatin. Thus 28 of the 31 General Chapters and 46 of the 60 excipient monographs on the current work programme have been harmonised among the PDG Pharmacopoeias.
Press release - Update on the review of CEP applications for sartans and the availability of test methods for nitrosamines - October 2018
Following the detection of the impurity NDMA (N-nitrosodimethylamine) in valsartan at the end of June, the EDQM has conducted a complete review of the manufacturing information submitted in all Certificate of suitability (CEP) applications for valsartan and other structurally related active substances. The EDQM contacted those manufacturers of valsartan and other sartans holding CEPs which might have presented a risk of contamination with nitrosamines, including NDMA and NDEA (N-nitrosodiethylamine). Both contaminants are classified as probable human carcinogens (substances that may cause cancer).
Presse Release - EDQM launches public consultation on first pilot monographs for European Paediatric Formulary - October 2018
The EDQM has launched a public consultation on the first two pilot monographs and on two general texts for its European Paediatric Formulary. Pharmacists and paediatricians across Europe are called to provide their feedback on the draft monographs on Hydrochlorothiazide oral solution and on Sotalol oral solution.
Press Release 25 2018 - Quality of gene therapy products: EDQM listens to stakeholders’ needs - October 2018
The EDQM is the Directorate of the Council of Europe responsible for supporting the basic human right of access to good quality medicines and health care in Europe. With its European Pharmacopoeia (Ph. Eur.), the EDQM sets requirements for the quality of medicines, including those in the field of Gene Therapy Products (GTPs).
Press Release - EDQM issues recommendations for sustainable, cost-effective quality management in Europe’s blood sector - September 2018
The EDQM has issued a set of recommendations for the development of cost-effective and sustainable Quality Management Systems (QMSs) in Blood Establishments (BEs) across Europe. The document follows on from the European Conference on “Sharing best practices: Quality Risk Management, Change Control, Validation and Qualification in Blood Establishments”, held by the EDQM in October 2017 in Strasbourg.
Press Release - Just released: 2017 international figures for organ donation and transplantation - September 2018
Monitoring of practices in the field of organ donation and transplantation allows strengthened transparency, as well as international benchmarking. The Newsletter Transplant, which is issued by the EDQM/Council of Europe every year in coordination with the National Transplant Organisation in Spain, is the official source of information that can be used as basis for policy making globally.