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News | 19 April 2021 | Strasbourg, France
The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), held videoconferences on 6 November 2020 and on 12 March 2021. WHO (International Pharmacopoeia) participated as Observer.
News | 16 April 2021 | Strasbourg, France
The 169th Session of the European Pharmacopoeia (Ph. Eur.) Commission, held in March, saw the adoption of the revised general monograph on Essential oils (2098) and of the new chapter on Monographs on essential oils (information chapter) (5.30).
News | 09 April 2021 | Strasbourg, France
All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.2 is 30 June 2021.
News | 08 April 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
News | 07 April 2021 | Strasbourg, France
The EDQM announces the availability of 1 new European Pharmacopoeia (Ph. Eur.) reference standard and 14 replacement batches for Ph. Eur. reference standards.
News | 07 April 2021 | Strasbourg, France
The Guideline for Pandemic COVID-19 vaccine (mRNA) has been updated to include a model protocol for the submission of manufacturers’ data. In force since 12 November 2020, this key guideline presents the list of tests to be carried out by an Official Medicines Control Laboratory (OMCL) for Official Control Authority Batch Release (OCABR).
News | 06 April 2021 | Strasbourg, France
The 169th session of the European Pharmacopoeia (Ph. Eur.) Commission took place on 23 and 24 March 2021.At this session, the Commission adopted 68 texts for publication in Ph. Eur. Supplement 10.7, including 9 new texts.
News | 31 March 2021 | Strasbourg, France
At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted revised chapter 2.2.48 on Raman Spectroscopy.
News | 30 March 2021 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has been informed that certain commercial providers of reference standards claim their key staff are former senior employees of the EDQM. To the knowledge of the EDQM, this is not the case.
News | 24 March 2021 | Strasbourg, France
On 9 and 10 March 2021, a workshop aimed at facilitating the implementation of replacement in vitro toxicity and antigenicity assays for Clostridium septicum vaccine antigens was jointly organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM/Council of Europe), the European Partnership for Alternative Approaches to Animal Testing (EPAA) and the European...
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...