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Transplantation / Tissue | News | 06 July 2020 | Strasbourg, France
As the COVID-19 pandemic begins to stabilise and we gradually return to normal daily life, it will be important to continue to ensure a safe and sufficient supply of tissues from deceased donors and to support donation and transplantation programmes. Additional measures will have to be taken to foster safe practice within tissue establishments and to minimise the risks related to SARS-CoV-2 for...
Products and Services | News | 06 July 2020 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Supplement 10.3 is now available and will be applicable in 39 European countries as of 1 January 2021.
Products and Services | News | 03 July 2020 | Strasbourg, France
The EDQM announces the availability of: 14 New Ph. Eur. reference standards 18 Replacement batches for Ph. Eur. reference standards
European Pharmacopoeia / General text/chapter | 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...
EDQM / All activities | 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.
European Pharmacopoeia / Public enquiry | 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...
Certification of suitability (CEP) | 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...
European Pharmacopoeia / Ph. Eur. Commission | 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...
European Pharmacopoeia / Public enquiry | 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.).
European Pharmacopoeia | 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.
Anti-falsification activities / Steering Committee | 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.
European Pharmacopoeia / General | 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.
Reference Standard / Collection & Catalogue | 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.