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News | 06 May 2021 | Strasbourg, France
The EDQM announces the availability of: 7 new European Pharmacopoeia (Ph. Eur.) reference standards and 26 replacement batches for Ph. Eur. reference standards.
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).
Certification of suitability (CEP) / Procedure of certification (general) | News | 06 May 2021 | Strasbourg, France
The latest monthly activity report for the Certification of Substances Department (DCEP) is now available.
News | 05 May 2021 | Strasbourg, France
In January 2019, the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Commission (EC) organised the International Symposium on Plasma Supply Management. This event – the first of its kind – brought together stakeholders in the blood sector to discuss the increasing use of plasma for fractionation. Participants addressed the matter of increasing the...
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
Following recent investigations demonstrating the mutagenicity of an azido impurity in sartan active substances (APIs) with a tetrazole ring, the EDQM confirms that the CEP holders concerned have already been contacted and have addressed the issue as requested.
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 | 23 April 2021 | Strasbourg, France
The new Official Control Authority Batch Release (OCABR) Guideline for Pandemic COVID-19 Vaccine (Recombinant Spike Protein), containing the agreed list of tests to be performed by Official Medicines Control Laboratories (OMCLs) for OCABR, is now available and is in force from 20 April 2021.
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 | 21 April 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 33.2. The table below lists the substances affected by these revisions and for which a certificate of suitability to the Ph. Eur. monographs (CEP) has been granted.
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.