News | 01 July 2020 | Strasbourg, France
Published in European Pharmacopoeia (Ph. Eur.) Supplement 10.3, the new general chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C describes a test for bacterial endotoxins (BET) that can be used as an alternative to the classic limulus amoebocyte lysate (LAL)-based methods for the quantification of endotoxins from gram-negative bacteria. The method described involves the...
News | 30 June 2020 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare’s 2019 annual report is now available, providing a comprehensive overview of our activities in 2019 and information on our achievements and events.
News | 26 June 2020 | Strasbourg, France
Due to high public interest and the importance of the text, it has been decided to extend the consultation period for the new general chapter on Extractable elements in plastic materials for pharmaceutical use (2.4.35) to give stakeholders more time to comment. Originally published in Pharmeuropa 32.2, this draft chapter covers elemental impurities that may be present in plastic materials used in...
News | 23 June 2020 | Strasbourg, France
Would you like to build a career in regulatory affairs? Do you have excellent chemical synthesis or analytical chemistry skills? Do you have the scientific expertise required to check the acceptability of applications for Certification of Suitability to the monographs of the European Pharmacopoeia (CEP) on receipt, to critically review data according to ICH, EU and EDQM guidelines, to prepare...
News | 22 June 2020 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) is seeking feedback on revised chapter 2.2.48 on Raman Spectroscopy. Raman spectrometers are increasingly deployed in the pharmaceutical environment. Offering user-friendly interfaces and rapid, non-destructive measurements generating essential information about the sample, their popularity has been further increased by the development of handheld, automated...
News | 15 June 2020 | Strasbourg, France
The EDQM would like to warmly thank its stakeholders for their invaluable feedback and their commitment to the work of the European Pharmacopoeia (Ph. Eur.).
News | 11 June 2020 | Strasbourg, France
Further to the publication of the COVID-19 vaccine developers’ package of pharmacopoeial texts (see “EDQM provides COVID-19 vaccine developers with free access to quality standards applicable in Europe”), the EDQM has compiled a companion list of training materials on the European Pharmacopoeia (Ph. Eur.) and on Ph. Eur. texts related to vaccines.
News | 09 June 2020 | Strasbourg, France
The Committee of Experts on Minimising Public Health Risks Posed by Falsification of Medical Products and Similar Crimes (CD-P-PH/CMED) held its spring meeting via videoconference from 26 to 28 May 2020. Some 35 delegates from 24 countries participated. A dedicated discussion took place to exchange experience and information related to the COVID-19 crisis.
News | 08 June 2020 | Strasbourg, France
The EDQM is committed to supporting vaccine developers during the coronavirus disease (COVID-19) pandemic – as well as contributing to the wider global effort to combat the virus – by openly sharing knowledge and offering temporary free access to relevant guidance and standards.
News | 04 June 2020 | Strasbourg, France
The EDQM announces the availability of 7 new Ph. Eur. reference standards and 14 replacement batches for Ph. Eur. reference standards in May 2020.
News | 28 May 2020 | Strasbourg, France
The annual meeting of the European Network of Official Medicines Control Laboratories (OMCLs) took place from 12 to 15 May 2020, online and with a reduced programme due to the COVID-19 crisis. It was attended by more than 350 participants from 39 countries and was organised by the EDQM.
News | 26 May 2020 | Strasbourg, France
The EDQM, Council of Europe, has just released the 20th edition of the Guide to the preparation, use and quality assurance of blood components (also known as the Blood Guide). Used in more than 90 countries, the Blood Guide is considered a gold standard in blood transfusion. It supports professionals in applying common, harmonised standards in this field to protect donors for the benefit of...
News | 20 May 2020 | Strasbourg, France
The EDQM is organising four free webinar training sessions on the European Pharmacopoeia and related activities of the EDQM. These webinars will cover many important aspects of the work and procedures of the European Pharmacopoeia (e.g. impurity controls or new and revised chapters), the establishment and use of Ph. Eur. Reference Standards, as well as an overview of the Certification of...
News | 18 May 2020 | Strasbourg, France
The European Pharmacopoeia Commission granted observer status to Mexico during its 166th session (March 2020). This decision demonstrates the dynamism of the European Pharmacopoeia (Ph. Eur.), which now has 30 observers from around the world in addition to the 39 European countries and the European Union as signatory parties.
News | 14 May 2020 | Strasbourg, France
The new edition of the Technical Guide for the elaboration and use of monographs for immunological veterinary medicinal products (2020) was approved by the European Pharmacopoeia (Ph. Eur.) Commission at its 166th session.