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.
Certification of suitability (CEP) / API | News | 10 July 2020 | Strasbourg, France
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...
EDQM / All activities | News | 09 July 2020 | Strasbourg, France
The EDQM will be closed on Monday 13 and Tuesday 14 July 2020.
Certification of suitability (CEP) / Procedure of certification (general) | News | 08 July 2020 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
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.
Transplantation / Tissue | News | 06 July 2020 | Strasbourg, France
As the COVID-19 pandemic begins to stabilise and we gradually return to normal daily life, it will be important to continue to ensure a safe and sufficient supply of tissues from deceased donors and to support donation and transplantation programmes. Additional measures will have to be taken to foster safe practice within tissue establishments and to minimise the risks related to SARS-CoV-2 for...
Products and Services | News | 03 July 2020 | Strasbourg, France
The EDQM announces the availability of: 14 New Ph. Eur. reference standards 18 Replacement batches for Ph. Eur. reference standards
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...
Certification of suitability (CEP) | News | 23 June 2020 | Strasbourg, France
Would you like to build a career in regulatory affairs? Do you have excellent chemical synthesis or analytical chemistry skills? Do you have the scientific expertise required to check the acceptability of applications for Certification of Suitability to the monographs of the European Pharmacopoeia (CEP) on receipt, to critically review data according to ICH, EU and EDQM guidelines, to prepare...
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.).
EDQM / All activities | News | 11 June 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.