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Paediatric Formulary | News | 16 October 2020 | Strasbourg, France
During the COVID-19 pandemic caused by SARS-CoV-2, clinical trials aimed at demonstrating the safety and efficacy of established active substances in this new indication are currently ongoing and medicinal products are also being used experimentally in clinical practice. Reference is made to the WHO information on “Clinical management of severe acute respiratory infection (SARI) when COVID-19...
European Pharmacopoeia / International harmonisation | News | 14 October 2020 | Strasbourg, France
The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia, held its annual autumn meeting via videoconference on 22-23 September 2020, with WHO attending as observer. Due to the COVID-19 pandemic, the face-to-face meeting originally scheduled was reorganised as a videoconference devoted entirely to...
European Pharmacopoeia / Public enquiry | News | 02 October 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 32.4 is 31 December 2020.
European Pharmacopoeia / Monograph | News | 02 October 2020 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Supplement 10.4 is now available and will be applicable in 39 European countries as of 1 April 2021.
European Pharmacopoeia / Public enquiry | News | 01 October 2020 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) is seeking feedback on its new general text on the implementation of pharmacopoeial procedures (5.26).
European Pharmacopoeia / Ph. Eur. Commission | News | 29 September 2020 | Strasbourg, France
At its 167th session in June 2020, the European Pharmacopoeia Commission adopted revised dosage form monographs on transdermal patches, cutaneous patches and medicated plasters, as well as the related test method for dissolution testing.
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...