2021 Highlights – EDQM annual report now available

EDQM 23/05/2022 Strasbourg, France

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 figures in the introductory section, allowing...

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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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New Pharmeuropa Bio & Scientific Notes article now online: Human immunoglobulin for ACA BRP

EDQM 13/04/2022 Strasbourg, France

A new scientific article on the outcome of a recently concluded Biological Standardisation Programme (BSP) study has been published in Pharmeuropa Bio & Scientific Notes 2022. Four replacement batches of the European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP) for Human...

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Proceedings of Workshop on alternatives to animal testing in Quality Control of Veterinary Vaccines now available

EDQM 12/04/2022 Strasbourg, France

The proceedings of the workshop "Novel in-vitro model as alternative to in vivo toxoid vaccines testing: Clostridium septicum vaccine as proof of concept" have been published in FreePub, a free online EDQM journal. The event, held in March 2021, was jointly organised by the European Directorate...

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European Pharmacopoeia 11th Edition International Conference: early-bird registration now available

EDQM 11/04/2022 Strasbourg, France

Registration is now open for the international conference to mark the launch of 11th Edition of the European Pharmacopoeia (Ph. Eur.). The conference will take place from 19 to 21 September 2022, both in-person, in Strasbourg (France), and virtually. The main themes of the conference are...

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Outcome of the 172nd session of the European Pharmacopoeia Commission, March 2022

EDQM 11/04/2022 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission held its 172nd session on 22 and 23 March 2022. The Commission adopted 78 texts at this session, to be published in Ph. Eur. Supplement 11.1 and be effective as of 1 April 2023. These 78 texts included six new monographs and one new general...

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Ph. Eur. Commission elects its new Chair at 172nd Session

EDQM 08/04/2022 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission held its 172nd Session on 22 and 23 March 2022. Among other decisions, the Commission elected its new Chair, Professor Salvador Cañigueral. Professor Cañigueral has been first Vice-chair to the Commission since June 2019. He will take up his duties...

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New EDQM website, redesigned to better serve your needs – Now online!

EDQM 01/04/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just launched its redesigned website. Discover the following new features. Improved, user-friendly navigation by main topics. This means faster access – in fewer clicks – to the information you need using the top menu...

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Pharmeuropa 34.2 just released

EDQM 04/04/22 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 34.2 is 30 June 2022. Users and interested parties are welcome to comment on these drafts. It should be...

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Ph. Eur. to launch survey for the use of total organic carbon (TOC) test as a replacement of oxidisable substances test in Water for injections

EDQM 17/03/2022 Strasbourg, France

The experts of the European Pharmacopoeia (Ph. Eur.) are considering replacing the test for oxidisable substances by the test for total organic carbon (TOC) in the Tests section of the “Sterilised water for injections” part of the monograph on Water for injections (0169). This change has been...

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EDQM event "Quality requirements for nanomedicines"

EDQM 11/03/2022 Strasbourg, France

The COVID-19 pandemic and the emergence of mRNA vaccines have highlighted the importance of nanoparticle formulations – especially lipid-based systems – used for nucleic acid-based APIs. The success of SARS-CoV-2 vaccination programmes around the globe has demonstrated that these...

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SAVE THE DATE! Conference celebrating the publication of the 11th Edition of the European Pharmacopoeia (19-21 September 2022)

EDQM 04/03/2022 STRASBOURG, FRANCE

After almost two years of online events, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is eager to announce the organisation of an international conference to celebrate the publication of the 11th Edition of the European Pharmacopoeia (Ph. Eur.). This in-person event...

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Suspension of shipments

EDQM 02/03/2022 STRASBOURG, FRANCE

Due to the recent events in Ukraine, all carriers have suspended their activities in Belarus, Moldova, Russia and Ukraine until further notice. Therefore, the EDQM can no longer proceed with any shipments for Reference Standards, Publications or PTS to these countries.

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New Webinar: What has changed in the Ph. Eur. General Notices?

EDQM 18/02/2022 Strasbourg, France

The General Notices is the European Pharmacopoeia (Ph. Eur.) go-to chapter that contains important information applicable to all Ph. Eur. texts. Its content is relevant for any user seeking to understand not just the conventional expressions and terminology used throughout the Ph. Eur. but also...

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Ph. Eur. Commission adopts harmonised general chapter 2.2.46. Chromatographic separation techniques

EDQM 15/02/2022 Strasbourg, France

At its 171st session in November 2021, the European Pharmacopoeia (Ph. Eur.) Commission adopted a new version of one of its widely used general chapters, Chromatographic separation techniques (2.2.46). The text has been revised to take account of the pharmacopoeial harmonisation text, signed-off...

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