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Past News

News | 06 December 2018 | Strasbourg, France
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.
News | 30 November 2018 | Strasbourg, France
At its 162nd Session in Strasbourg on 20-21 November 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 16 new texts and 128 revised texts. All of the adopted texts help ensure that the Ph. Eur. remains up to date and in line with the latest regulatory developments and scientific state of the art; they will be effective from 1 January 2020 and will be published in 10th Edition of...
News | 28 November 2018 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission decided to restructure Section 3. of the Ph. Eur. on materials and containers. A new Subsection 3.3. has been added to Section 3. in order to cover specific medical devices: containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.
News | 20 November 2018 | Strasbourg, France
The revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs’ (PA/PH/CEP (04) 2 7R) will enter into force in January 2019. Notable changes include the classification of changes related to the introduction of a new manufacturer of a starting material (see page 7), explicit reference to recent changes in the regulatory...
News | 19 November 2018 | Strasbourg, France
Following new information recently received by EDQM about the detection of low levels of N-nitrosodiethylamine (NDEA) in Valsartan manufactured by MYLAN LABORATORIES Ltd , the EDQM has immediately suspended the certificate of suitability (CEP) R1-CEP 2009-396-Rev 03/Valsartan held by this company, until appropriate corrective actions are taken.
News | 16 November 2018 | Strasbourg, France
The expertise of the EDQM laboratory has recently been confirmed by an ISO 17025 accreditation for Nuclear Magnetic Resonance spectroscopy (NMR) and quantitative Nuclear Magnetic Resonance spectroscopy (qNMR). These modern and state of the art techniques further expand the technical competence of the EDQM laboratory to characterise the official reference standards of the European Pharmacopoeia (...
News | 08 November 2018 | Strasbourg, France
The Council of Europe Convention against Trafficking in Human Organs was ratified by Portugal on 8 November 2018 and will commence having legal effect in the country as of 1 March 2019. The Convention identifies various activities constituting human organ trafficking which ratifying member states must consider as criminal offences.
News | 06 November 2018 | Strasbourg, France
The Organ Guide now in its 7th Edition supports professionals on a practical level to improve the rate of successful and safe organ transplantation. The Organ Guide collates updated information to provide professionals with the most recent advances in the field, as well as technical guidance to ensure the safety and quality of human organs intended for transplantation.
News | 06 November 2018 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on Ph. Eur. dosage form monograph on Parenteral preparations (0520) and new informative chapter on testing for visible particles (5.17.2)
News | 30 October 2018 | Strasbourg, France
Your input is essential to shape future European Pharmacopoeia (Ph. Eur.) monographs and helps keep texts relevant and fit for purpose. The issue 30.4 of Pharmeuropa is complete and ready for comments: manufacturers and users have until 31 December 2018 to provide their feedback on draft Ph. Eur. texts and to verify their products’ compliance with the new or revised drafts monographs.
News | 30 October 2018 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its new general chapter 5.1.12 on depyrogenation of items used in the production of parenteral preparations. While depyrogenation is not a new topic for the Ph. Eur., this is the first time that a dedicated chapter covers specifically the inactivation of pyrogens and related endotoxin indicators. Pyrogens are substances...
News | 24 October 2018 | Strasbourg, France
Recently released: 2 new Ph. Eur. Reference standards Zoledronic acid monohydrate and Infliximab BRP, as well as 16 replacement batches
News | 24 October 2018 | Strasbourg, France
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.
News | 17 October 2018 | Strasbourg, France
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...
News | 12 October 2018 | Strasbourg, France
Organ transplantation is one of the great medical success stories of the 20th century, over the past few decades it has improved the quality of life of hundreds of thousands of patients. The most recent data show that more than 144 000 patients are waiting for a transplant in Council of Europe member states, and each day, 18 patients on waiting lists die waiting for an organ that never arrived...