European Pharmacopoeia / Ph. Eur. Commission | News | 17 September 2020 | Strasbourg, France
At its 167th session in June 2020, the European Pharmacopoeia (Ph. Eur.) Commission adopted the revised version of the dosage form monograph on Parenteral preparations (0520) which gives mandatory quality requirements for a large number of medicinal products on the European market.
European Pharmacopoeia / Medicine for veterinary use | News | 11 September 2020 | Strasbourg, France
So you missed the webinars on 1 April but have questions about the updated approach to extraneous agent testing in IVMPs? To provide long-term user support on IVMP testing policy, the EDQM is making two documents available. The first summarises what has changed and why, the second summarises the content of the training webinars which took place on 1 April 2020.
European Pharmacopoeia / Monograph | News | 08 September 2020 | Strasbourg, France
The approach to the elaboration of European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutics has significantly evolved in recent years. In particular, where monographs on complex biotherapeutics are concerned, the emphasis is now placed on allowing greater flexibility as a means of better addressing the structural complexity and naturally occurring heterogeneity of these substances, and...
EDQM / All activities | News | 17 August 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 / 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.
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.