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European Pharmacopoeia / Ph. Eur. Commission | News | 11 May 2020 | Strasbourg, France
At its 166th session (March 2020), the European Pharmacopoeia (Ph. Eur.) Commission adopted a new chapter on Multivariate Statistical Process Control (5.28). The Ph. Eur. is the first pharmacopoeia to tackle this topic.
European Pharmacopoeia / Ph. Eur. Commission | News | 06 May 2020 | Strasbourg, France
At this session, the Ph. Eur. Commission adopted 91 texts for publication in Ph. Eur. Supplement 10.4, including 11 new texts. The list of all adopted texts will be made available on the EDQM website: Ph. Eur. Work Programme and Ph. Eur. publication schedule. These texts will be effective as of 1 April 2021 and will be published in Supplement 10.4 of the Ph. Eur.
European Pharmacopoeia / International harmonisation | News | 28 April 2020 | Strasbourg, France
The Pharmacopoeial Discussion Group (PDG) held its interim videoconference on Thursday 12 March 2020. The PDG – which brings together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), with WHO (International Pharmacopoeia) as Observer, to discuss international harmonisation of quality standards – has now completed work on 28 of the 31...
EDQM / All activities | News | 24 April 2020 | Strasbourg, France
Free training resources: online sessions for home learning – Sign up today! Online training is the ideal way to improve your skills during quarantine. Why not make the most of your time at home to pick up new skills and gain valuable knowledge by attending an online training session? The good news is that all the EDQM training sessions and webinars are available free online, covering a wide...
European Pharmacopoeia / General | News | 20 April 2020 | Strasbourg, France
The European Pharmacopoeia and the British Pharmacopoeia have worked together to make supportive pharmacopoeial texts (monographs, general chapters, appendices and supplementary chapters) available for a limited period of time at no cost to users. This is to support those developing, manufacturing or testing these substances and products during this challenging period. These texts will be...
European Pharmacopoeia / Monograph | News | 17 April 2020 | Strasbourg, France
The EDQM would like to inform users of the European Pharmacopoeia of the forthcoming correction of the limit for sulfated ash in the French version of the Kanamycin monosulfate (0032) monograph. The limit which is given as 1.5% in the French version will be corrected to 0.5% as it appears in the English version of the text.
Paediatric Formulary | News | 17 April 2020 | Strasbourg, France
The European Paediatric Formulary (PaedF) Working Party, in this exceptional situation, wishes to serve pharmacists by compiling existing knowledge on paediatric formulations for active substances under investigation as well as known authorised medicinal products. Information on paediatric formulations of active substances used in clinical trials but also experimentally in clinical practice...
European Pharmacopoeia / Public enquiry | News | 16 April 2020 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) currently includes two monographs on oxygen: Oxygen (0417) and Oxygen (93 per cent) (2455).
European Pharmacopoeia / Public enquiry | News | 15 April 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 32.2 is 30 June 2020.
European Pharmacopoeia | News | 07 April 2020 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) is seeking feedback on its new general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36).
European Pharmacopoeia / Ph. Eur. Commission | News | 31 March 2020 | Strasbourg, France
In January 2017, the EDQM published an update on the European Pharmacopoeia (Ph. Eur.) policy on elemental impurities in which the special case of excipients of natural origin was highlighted. At the time, and based on feedback gathered from stakeholders during workshops and conferences, the Ph. Eur. Commission decided to make an exception for these substances and keep the specific elemental...
European Pharmacopoeia / Announcements | News | 24 March 2020 | Strasbourg, France
Are you ready to comply with the new European Pharmacopoeia (Ph. Eur.) revised text on extraneous agent testing in immunological veterinary medicinal products (IVMPs)? The approach to extraneous agent testing in IVMPs has recently been updated and manufacturers of these products are required to comply with new standards from 1 July 2020. The EDQM is organising two free webinar sessions to help Ph...
European Pharmacopoeia / Animal testing | News | 24 March 2020 | Strasbourg, France
At its 165th session (November 2019), the European Pharmacopoeia (Ph. Eur.) Commission adopted 16 revised monographs on tetanus vaccines, following a re-assessment of toxicity testing requirements. The revisions include the suppression of three tests and the harmonisation, as far as possible, of the Ph. Eur.’s toxicity testing requirements for tetanus vaccines for human and veterinary use.
EDQM / All activities | News | 19 March 2020 | Strasbourg, France
Due to the measures implemented by the French government in its fight against the COVID-19 pandemic, the EDQM will, until further notice, only be able to answer queries through its Online HelpDesk. We will continue to do our utmost to provide you with the best possible service, but please note that there may still be delays in processing requests.
European Pharmacopoeia / General text/chapter | News | 09 March 2020 | Strasbourg, France
In January 2020, the European Pharmacopoeia (Ph. Eur.) launched a public consultation on a new general chapter on Balances (2.1.7). Users and concerned parties can submit their comments in Pharmeuropa 32.1 until 31 March 2020. Please use this last opportunity to send us your contributions!