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News | 17 March 2021 | Strasbourg, France
In February 2021, the Ph. Eur. Commission revised the five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600), using the rapid revision process. The Production section was reworded and the N-nitrosamines test section was deleted.
News | 17 March 2021 | Strasbourg, France
The five monographs on sartans with a tetrazole ring, namely Valsartan (2423), Losartan potassium (2232), Irbesartan (2465), Candesartan cilexetil (2573) and Olmesartan medoxomil (2600) have been revised to align them with the latest regulatory recommendations issued by the CHMP that were published on 13 November 2020 on the EMA’s website. The revision concerns a rewording of the “Production”...
News | 12 March 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
News | 11 March 2021 | Strasbourg, France
In order to facilitate the acceptance of proposed changes in a timely manner, CEP holders are reminded that the European Directorate for the Quality of Medicines & HealthCare (EDQM) Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2, 7R corr) lists different notifications and associated conditions, and that...
News | 09 March 2021 | Strasbourg, France
A live, interactive webinar held on 17 February 2021 addressed the challenges that data protection presents for blood establishments (BEs), as a follow-up to the European Directorate for the Quality of Medicines & HealthCare (EDQM) Blood Quality Management (B-QM) conference “Keeping up with Reality and Quality: A Challenge for European Blood Establishments” (27-29 October 2020). Participants...
News | 04 March 2021 | Strasbourg, France
The EDQM announces the availability of 7 new European Pharmacopoeia (Ph. Eur.) reference standards and 30 replacement batches for Ph. Eur. reference standards.
News | 01 March 2021 | Strasbourg, France
The European Pharmacopoeia Commission has revised via a rapid implementation procedure the five “sartan” monographs (Valsartan, Losartan potassium, Candesartan cilexetil, Olmesartan medoximil and Irbesartan); they will enter into force on 1 April 2021 to align them with the CHMP decision on the detection, management and prevention of the presence of N-nitrosamines in “sartan medicinal products” (...
News | 24 February 2021 | Strasbourg, France
The European Committee on Blood Transfusion (CD-P-TS) has approved the publication of the 2016 edition of “The collection, testing and use of blood and blood components in Europe”. In total, 28 Council of Europe member states, representing some 430 million inhabitants, reported annual data for 2016 by responding to a detailed survey.
News | 22 February 2021 | Strasbourg, France
This webinar is intended to support users and stakeholders in the swift implementation of the new general chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C by answering the following questions: What conditions need to be met? What needs to be verified? Is validation required? What needs to be done when using recombinant factor C (rFc) instead of LAL? What is an...
News | 09 February 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
News | 08 February 2021 | Strasbourg, France
The European Pharmacopeia (Ph. Eur.) regularly updates its dosage form monographs and related general chapters to ensure that they continue to reflect current practices and scientific progress. Pharmeuropa 33.1, this quarter’s issue, therefore features the revised Uniformity of mass of single-dose preparations (2.9.5) which now includes specific requirements for additional single-dose...