News | 04 February 2021 | Strasbourg, France
At its 168th session in November 2020, the European Pharmacopoeia (Ph. Eur.) Commission adopted revised versions of three dosage form monographs and two related general chapters, together with one new general chapter. While the revised texts cover a large number of medicinal products including all eye and ear preparations, and all large oral tablets and capsules above 18 mm in size, the new...
News | 03 February 2021 | Strasbourg, France
The EDQM announces the availability of 5 new European Pharmacopoeia (Ph. Eur.) reference standards and 17 replacement batches for Ph. Eur. reference standards in January 2021.
News | 26 January 2021 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) general monograph Pharmaceutical preparations (2619) requires manufacturers of products outside the scope of general chapter 5.20 to control the levels of elemental impurities in products using the principles of risk management.
News | 22 January 2021 | Strasbourg, France
How can we ensure equitable access to vaccination during the current and future pandemics? The Council of Europe Committee on Bioethics has made today a number of recommendations.
News | 21 January 2021 | Strasbourg, France
The EDQM/Council of Europe will implement the “Reorganisation of the Romanian Blood System” project. The project aims to support Romania in setting up a fit-for-purpose and efficient blood transfusion system aligned with European Union and EDQM standards. The EDQM is therefore seeking experienced professionals to provide consultancy services in order to support the reorganisation of the Romanian...
News | 21 January 2021 | Strasbourg, France
The new Technical Guide for the elaboration of monographs on medicinal products containing chemically defined active substances (2020) was approved by the European Pharmacopoeia (Ph. Eur.) Commission at its 168th session in November 2020.
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).