Transplantation / Tissue | News | 20 April 2020 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare is pleased to invite you to a webinar to discuss how the COVID-19 pandemic is affecting national programmes for tissue donation from deceased donors and daily practices in tissue establishments and to support decisions moving towards the future. This webinar has been developed for the tissue donation and transplantation...
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 / 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.
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.
Products and Services | News | 15 April 2020 | Strasbourg, France
The EDQM is launching a new and improved WebStore for Reference Standards on 15 April 2020, following up on its most recent user satisfaction survey. You can also access it directly at https://RSform.edqm.eu.
Certification of suitability (CEP) / CEP new application | News | 14 April 2020 | Strasbourg, France
In the context of having switched to working remotely during the COVID-19 pandemic, the EDQM has prioritised certain activities linked with CEPs over others and it is important to share this with our stakeholders.
Certification of suitability (CEP) / Procedure of certification (general) | Notification | 07 April 2020 | Strasbourg, France
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 32.2 before 30 June 2020. More information in document PA/PH/CEP (20) 17.
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).
Reference Standard / Collection & Catalogue | News | 03 April 2020 | Strasbourg, France
The EDQM announces the availability of 18 replacement batches for European Pharmacopoeia (Ph. Eur.) reference standards.
Reference Standard / Collection & Catalogue | News | 02 April 2020 | Strasbourg, France
The EDQM will soon be launching a new and improved WebStore for Reference Standards, following up on its most recent customer satisfaction survey.
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...
Certification of suitability (CEP) / Nitrosamines | News | 27 March 2020 | Strasbourg, France
The EDQM recognises that due to the impact of the global outbreak of COVID-19, many CEP holders are encountering significant challenges in completing the work within the timelines previously announced in the EDQM request to CEP holders to perform a risk evaluation of their chemically synthesised APIs with regards nitrosamine formation, published on the EDQM Website (EDQM request October 2019).
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.
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...