Ph. Eur. Commission establishes a new working party on mRNA vaccines

EDQM 03/08/2022 Strasbourg, France

At its 173rd session in June 2022, the European Pharmacopoeia (Ph. Eur.) Commission decided to start working on mRNA vaccines by establishing the mRNAVAC Working Party, entrusted with elaborating quality standards supporting this emerging field that will be included in the Ph. Eur. The newly...

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General chapter 2.2.46. Chromatographic separation techniques now published in Ph. Eur. 11th Edition

EDQM 27/07/2022 Strasbourg, France

General chapter 2.2.46. Chromatographic separation techniques has been revised to incorporate the provisions of the pharmacopoeial harmonisation text, signed-off by the Pharmacopoeial Discussion Group (PDG) on 28 September 2021. The revised chapter is now available in the 11th Edition of the...

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Call for experts: join the Ph. Eur. network

EDQM 18/07/2022 Strasbourg, France

Quality control of medicinal products containing chemically defined active substances and of the corresponding active substances contained in such medicinal products

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What’s new for homoeopathic preparations at European level?

EDQM 11/07/2022 Strasbourg, France

First revision of the Guide for the elaboration of monographs on homoeopathic preparations (Edition 2022) As announced in the press release dated 11 April 2022, the European Pharmacopoeia (Ph. Eur.) Commission approved the revised version of the Guide for the elaboration of monographs on...

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Outcome of the 173rd session of the European Pharmacopoeia Commission, June 2022

EDQM 05/07/2022 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission held its 173rd session on 21 and 22 June 2022. Forty-eight texts were adopted and will be published in Ph. Eur. Supplement 11.2, effective as of 1 July 2023. Of these 48 texts, four were new monographs: Pumpkin seed (2941), Propylene glycol...

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New edition of the Technical Guide for the elaboration of Ph. Eur. monographs ready for publication

EDQM 07/07/2022 Strasbourg, France

At its 173rd session, the European Pharmacopoeia Commission approved the publication of a new edition of the Technical Guide for the elaboration of monographs. This guide is an essential aid both to the drafting of monographs and for the transposition of analytical techniques into a...

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Pharmeuropa 34.3 just released

EDQM 07/07/2022 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 34.3 is 30 September 2022. Users and interested parties are welcome to comment on these drafts. It...

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Revision of Heparin sodium (0333) and Heparin calcium (0332) monographs – feedback required

EDQM 30/06/2022 Strasbourg, France

First published in the 1980s, the monographs on unfractionated heparin are some of the earliest texts of the European Pharmacopoeia (Ph. Eur.). Since then, significant effort has been expended by the Ph. Eur. experts to regularly revise these texts, with the most significant series of revisions...

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Pharmacopoeial Discussion Group videoconference meeting

EDQM 28/06/2022 Strasbourg, France

The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia with WHO as observer, held its interim videoconference in two sessions on 15 and 28 March 2022. During this videoconference, the PDG discussed...

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BSP study publication: Somatropin/desamidosomatropin resolution mixture CRS 2

EDQM 27/06/2022 Strasbourg, France

An article on the outcome of the Biological Standardisation Programme (BSP) study for the establishment of the European Pharmacopoeia (Ph. Eur.) Somatropin/desamidosomatropin resolution mixture Chemical Reference Substance batch 2 is now available free online. The article has been published in...

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Call for experts: join the Ph. Eur. network

EDQM 23/06/2022 Strasbourg, France

Quality control of inorganic substances and synthetic and semi-synthetic organic substances

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EDQM ISO 9001:2015 certification renewed

EDQM 24/06/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) successfully obtained the renewal of its certification according to the ISO 9001:2015 standard from the AFNOR certification body, confirming the compliance of the Quality Management System of the EDQM with this standard....

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2021 Highlights – EDQM annual report now available

EDQM 14/06/2022 Strasbourg, France

Download: 2021 Highlights – EDQM annual report The 2021 annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM) is now available, providing a comprehensive overview of its activities and achievements. New to this edition is a four-page summary of key facts and...

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Register now for our upcoming training programme on the Ph. Eur., reference standards and CEPs

EDQM 31/05/2022 Strasbourg, France

8 independent modules – 8 topics – 8 Q&A sessions – All LIVE! This 100% virtual training will focus on chemically defined active substances and cover all the fundamentals related to the use of the European Pharmacopoeia and its reference standards, as well as the procedure for Certification of...

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Call for experts: join the Ph. Eur. network!

EDQM 06/04/2022 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) is seeking independent scientific experts to join its groups of experts and working parties. Professionals from national authorities (e.g. pharmacopoeial authorities, official medicines control laboratories, licensing authorities and inspectorates), the...

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Ph. Eur. Commission adopts first “horizontal standard” for monoclonal antibodies

EDQM 18/05/2022 Strasbourg, France

At its 172nd session in March 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted a new general chapter, Cell-based assay for potency determination of TNF-alpha antagonists (2.7.26), the first of three planned new horizontal standards for monoclonal antibodies (mAbs). The adoption of...

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European Pharmacopoeia 11th Edition (11.0-11.2) – Subscriptions now open!

EDQM 26/04/2022 Strasbourg, France

The 2023 subscriptions to the European Pharmacopoeia (Ph. Eur.), including the initial release (11.0) and the first two supplements (11.1-11.2), are now available for sale in the WebStore of the European Directorate for the Quality of Medicines & HealthCare (EDQM). Subscribers may choose either...

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New BSP study publication: Heparin Low-Molecular-Mass for Assay BRP

EDQM 09/05/2022 Strasbourg, France

An article on the outcome of the Biological Standardisation Programme (BSP) study for the establishment of the European Pharmacopoeia (Ph. Eur.) Heparin Low-Molecular-Mass for Assay Biological Reference Preparation batch 11 is now available online. The article has been published in Pharmeuropa...

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New policy for the development of monographs on medicinal products containing chemically defined active substance hydrates or solvates

EDQM 05/05/2022 Strasbourg, France

At its 172nd session in March 2022, the European Pharmacopoeia (Ph. Eur.) Commission approved a new policy for the development of monographs on medicinal products containing chemically defined active substances in hydrate or solvate form. This policy differentiates between hydrates, which have...

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New general text on comparability of alternative analytical procedures: European Pharmacopoeia launches public consultation

EDQM 13/04/2022 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) at the European Directorate for the Quality of Medicines & HealthCare (EDQM) is seeking feedback on its new general text on the comparability of alternative analytical procedures (5.27). The draft text elaborates on the requirement expressed more succinctly...

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