European Pharmacopoeia / Public enquiry | News | 15 July 2020 | Strasbourg, France
All new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 32.3 is 30 September 2020.
European Pharmacopoeia / Nitrosamines | News | 10 July 2020 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) published its new general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36) for a 3-month public consultation in Pharmeuropa 32.2. The closing date for public comments was 30 June 2020.
European Pharmacopoeia / Ph. Eur. Commission | News | 07 July 2020 | Strasbourg, France
The 167th session of the European Pharmacopoeia (Ph. Eur.) Commission on 23 June 2020 was the first ever to be held online, due to the COVID-19 pandemic. This unprecedented meeting successfully brought together over 130 members of the Ph. Eur. Commission, its 60 groups of experts and working parties and the scientific Secretariat, to ensure the continuity of the work of the Ph. Eur. was not...
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.
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...
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.
EDQM / All activities | News | 11 June 2020 | Strasbourg, France
The EDQM’s core activities include the provision of documentary and physical (reference) standards to ensure the quality of medicines and their ingredients. Availability of and access for patients to quality medicines is more important than ever in the context of the current COVID-19 pandemic.
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.
European Pharmacopoeia / General | 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...
European Pharmacopoeia / General | 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.
European Pharmacopoeia / Medicine for veterinary use | 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.