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Every year, European countries celebrate European Organ Donation Day (EODD). The idea behind this Day, initiated by the Council of Europe, is to encourage debate and provide information on organ, tissues and cells donation and transplantation, and legal and medical measures so that every European can decide about donation and make their wishes known to their family. Organ, tissues and cells transplantation is one of the great medical success stories of modern times and is the only life-saving treatment for end-stage organ failure in many conditions.
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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.
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Faisant suite à un article dans le quotidien neerlandais Nieuwe Rotterdamsche Courant Handelsblad (NFC) traitant d’une impureté (4-chloroaniline) dans la substance active paracétamol fabriqué par une compagnie identifiée comme titulaire d’un CEP, l’EDQM collabore activement avec la compagnie et les parties intéressées pour mieux comprendre l’impact potentiel de cette impureté et l’ampleur du problème.
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Following the publication of an article in the Dutch newspaper Nieuwe Rotterdamsche Courant Handelsblad (NRC) concerning an impurity (4-chloroaniline) in the active substance paracetamol manufactured by a specific company which holds a certificate of suitability, the EDQM is actively working with the company and other stakeholders to better understand the potential impact of this impurity and the extent of the issue.
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La Pharmacopée Européenne (Ph. Eur.) a publié dans Pharmeuropa 32.2, pour consultation publique de 3 mois, un nouveau chapitre général Contrôle des N-nitrosamines dans les substances actives (2.4.36). La date limite d’envoi des commentaires était fixée au 30 juin 2020.
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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.
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The Certification procedure remains impacted by the COVID-19 pandemic. The ongoing travel restrictions continue to affect severely the availability of experts for the evaluation of CEP dossiers, which has led to delays in their treatment.
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Please complete and return this form to Consumer Health, DBO, EDQM before 24 August 2020 by post: EDQM, 7, Allée Kastner, CS30026 F-67081 Strasbourg by fax: +33 (0)3 88 41 27 71 by email: consumer.health@edqm.eu
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Organisée le 23 juin 2020, la 167e session de la Commission européenne de Pharmacopée (« la Commission ») s’est déroulée en ligne — une grande première —, en raison de la pandémie de COVID-19. Cette réunion sans précédent a rassemblé avec succès plus de 130 membres de la Commission, de ses 60 groupes d’experts et groupes de travail et du Secrétariat scientifique, pour veiller à ce que la continuité des travaux de la Pharmacopée Européenne (Ph. Eur.) ne soit pas perturbée par la pandémie.
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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 disrupted by the pandemic.