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European Pharmacopoeia / Monograph | News | 04 October 2021 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Supplement 10.7 is now available and will be applicable in 39 European countries as of 1 April 2022.
Transplantation / European Organ Donation Day (EODD) | News | 30 September 2021 | Strasbourg, France
Organ, tissue and cell transplantation is one of the great medical success stories of modern times. In many cases, it is the only life-saving treatment for patients with end-stage organ failure, devastating burn injuries or blood cancers, and in many others it can significantly improve the quality of life of patients, for example by restoring their sight or helping them regain mobility.
Certification of suitability (CEP) / Chemical purity | News | 29 September 2021 | Strasbourg, France
In April 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) reported that it had received information about the possible presence of potentially mutagenic azido impurities in certain sartan active substances. Investigations requested by the EDQM indicated that only a few sources were impacted. A number of measures were taken to ensure that any active substance...
Certification of suitability (CEP) / Procedure of certification (general) | News | 27 September 2021 | Strasbourg, France
A revised version of the terms of reference and rules of procedure for the Certification of suitability to the monographs of the European Pharmacopoeia (CEP) procedure has been adopted by the Certification Steering Committee and is available on the website of the European Directorate for the Quality of Medicines & HealthCare (EDQM): Terms of Reference and Rules of Procedure (PA/PH/CEP (01) 1...
Certification of suitability (CEP) / Procedure of certification (general) | News | 24 September 2021 | Strasbourg, France
From the beginning of October 2021, the CEP Department (DCEP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) will use a new IT application for the management of its activities. The implementation of this tool will entail certain changes in the way the EDQM communicates with applicants for Certificates of Suitability to the European Pharmacopoeia monographs (CEPs...
European network of OMCLs | News | 22 September 2021 | Strasbourg, France
The 26th Annual Meeting of the European Network of Official Medicines Control Laboratories (OMCLs) took place from 6 to 10 September 2021 and was held virtually due to the ongoing pandemic situation. The meeting, organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM), was attended by more than 500 participants from 42 countries over the course of the week.
Transplantation / Publications / Transplant Newsletter | News | 21 September 2021 | Strasbourg, France
The 2021 edition of the Newsletter Transplant has just been published. It summarises comprehensive information and data for 2020 from 82 countries worldwide on donation and transplantation activities, management of waiting lists, organ donation refusals and authorised centres for transplantation activities.
Certification of suitability (CEP) | News | 14 September 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Reference Standard / Collection & Catalogue | News | 06 September 2021 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) announces the availability of 2 new European Pharmacopoeia (Ph. Eur.) reference standards and 15 replacement batches for Ph. Eur. reference standards.
European Pharmacopoeia / Ph. Eur. Commission | News | 03 September 2021 | Strasbourg, France
At its 168th session (November 2020), the European Pharmacopoeia (Ph. Eur.) Commission adopted a new general chapter: Balances for analytical purposes (2.1.7). This new chapter is included in Supplement 10.6 of the Ph. Eur., published in July 2021.
Certification of suitability (CEP) | News | 01 September 2021 | Strasbourg, France
As the eCTD format is mandatory for the submission of all applications for Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs), except for applications for the risk of transmissible spongiform encephalopathy (TSE) (PDF format) and for substances for veterinary use (eCTD or VNeeS format), the European Directorate for the Quality of Medicines & HealthCare (EDQM)...
Reference Standard / General | News | 27 August 2021 | Strasbourg, France
Are you interested in supporting the timely release of reference standards to users? Are you organised, result and service-oriented? Do you have good written and oral communication skills to be able to answer users’ questions? If so, this vacancy may be the right opportunity for you.
Certification of suitability (CEP) | News | 09 August 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
Products and Services | News | 05 August 2021 | Strasbourg, France
The EDQM announces the availability of 6 new European Pharmacopoeia (Ph. Eur.) reference standards and 16 replacement batches for Ph. Eur. reference standards.
European Pharmacopoeia / Biological standardisation programme (BSP) | News | 03 August 2021 | Strasbourg, France
Following the successful completion of the BSP090 study on recombinant major allergens, in collaboration with project leaders from the Paul-Ehrlich-Institut, an article on one of the major study outcomes “Validation of a candidate European Pharmacopoeia standard method for quantification of major grass pollen allergen Phl p 5” has recently been published in the scientific journal Allergy.