Council for europe portal
Language : en Search
Choose language

Newsroom

News | 20 January 2021 | Strasbourg, France
CEP holders are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.1. The table below lists the substances affected by these revisions and for which CEPs have been granted.
News | 19 January 2021 | Strasbourg, France
The Official Control Authority Batch Release (OCABR) Network for human vaccines and medicinal products derived from human blood and plasma and the National Institute of Biological Standards and Control (NIBSC, United Kingdom) have signed a memorandum of understanding (MOU) to renew, post-Brexit, the exchange and collaboration on common activities related to batch release of human vaccines and...
News | 18 January 2021 | Strasbourg, France
Supplement 10.5 of the European Pharmacopoeia (Ph. Eur) is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on 1 July 2021, and to follow the instructions given below.
News | 15 January 2021 | Strasbourg, France
At its 168th session, the Ph. Eur. Commission adopted Fritillariae thunbergii bulbus (2588), the first monograph to describe a test for minimum content of two markers (peimine and peiminine) by high-performance thin layer chromatography (HPTLC).
News | 13 January 2021 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare’s (EDQM) ISO 9001:2015 certificate has been maintained following the second surveillance audit of its quality management system on 7 and 8 December 2020 by the official French standardisation body Association française de normalisation (AFNOR), via AFNOR Certification (AFAQ).
News | 12 January 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
News | 08 January 2021 | Strasbourg, France
The United Kingdom left the EU on 31 January 2020 and the transition period for Brexit, during which EU legislation still applied, is over as of 31 December 2020. A trade deal for relations after 31 December 2020 has been negotiated between the EU and the UK, but the deal does not include mutual recognition of Official Control Authority Batch Release (OCABR) of vaccines for human use, human blood...
News | 06 January 2021 | Strasbourg, France
All new texts of the European Pharmacopoeia and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.1 is 31 March 2021.
News | 05 January 2021 | Strasbourg, France
At its 168th session in November 2020, the European Pharmacopoeia Commission adopted the new general chapter Contaminant pyrrolizidine alkaloids (2.8.26).
News | 04 January 2021 | Strasbourg, France
The EDQM announces the availability of 9 new European Pharmacopoeia (Ph. Eur.) reference standards and 10 replacement batches for Ph. Eur. reference standards in December 2020.
News | 04 January 2021 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) Supplement 10.5 is now available and will be applicable in 39 European countries as of 1 July 2021.
News | 21 December 2020 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
News | 17 December 2020 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 3 of Pharmeuropa PaedForm, in which the draft text for Phosphate 60 mg/mL Oral Solution is published for public consultation prior to its inclusion in the European Paediatric Formulary. This is the fourth monograph elaborated by the PaedForm Working Party.
News | 16 December 2020 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published an analytical method for the determination of polar N-nitrosamines in cosmetic products, which was validated within the European Network of Official Cosmetics Control Laboratories (OCCLs).
News | 16 December 2020 | Strasbourg, France
In June 2018, a manufacturer detected N-nitrosodimethylamine (NDMA) in valsartan active substance batches. This led to multiple regulatory actions addressing the presence of NDMA and other nitrosamine impurities, initially in valsartan but later extended to many other active substances. As 2020 draws to an end, the European Directorate for the Quality of Medicines & HealthCare (EDQM) wishes...