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EDQM / All activities | News | 06 May 2021 | Strasbourg, France
This virtual training will focus on chemically defined substances and cover all the fundamentals related to the use of the European Pharmacopoeia (Ph. Eur.) and its reference standards, as well as the procedure for Certification of suitability to the monographs of the European Pharmacopoeia (CEP).
News | 04 May 2021 | Strasbourg, France
When the experimental results allow, draft monographs will be published in Pharmeuropa with a peak area repeatability requirement of RSD ≤ 1.0% (n=6) determined on a solution containing the active substance CRS.
News | 03 May 2021 | Strasbourg, France
The IMWP monographs on Favipiravir and on Favipiravir tablets are an outcome of the pharmacopoeial alert system, which was established in 2019 at the 9th International Meeting of World Pharmacopoeias (IMWP) in Da Nang, Vietnam to ensure pharmacopoeias work together in any relevant public health crisis. An alert under this system was triggered in response to the COVID-19 pandemic to contribute to...
European Pharmacopoeia | News | 03 May 2021 | Strasbourg, France
At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission approved a new policy for the development of monographs on medicinal products containing chemically defined API salts and/or API (base/acid).
News | 29 April 2021 | Strasbourg, France
The 2022 subscriptions to the European Pharmacopoeia (Ph. Eur.) are now available for sale on the EDQM WebStore.
News | 22 April 2021 | Strasbourg, France
The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its proposal to delete the test for “heavy metals” (HMs, general chapter 2.4.8) in monographs on substances “for veterinary use only”. The 16 monographs concerned have been published in Pharmeuropa 33.2 together with other new texts and technical revisions of the Ph. Eur. The deadline for comments is 30 June 2021.
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 | 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 | 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
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 | 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 | 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...