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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Certification monthly report of activities: End of April 2022

EDQM 09/05/2022 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of April 2022 Certification Monthly Report For more information, access the Certification Database.

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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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24 replacement batches released in April 2022

EDQM 06/05/2022 Strasbourg, France

Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Information on change of price Change of EDQM storage/shipping conditions See also: Content of the Ph. Eur. RS catalogue How to place an RS order   The EDQM announces the release of: 24 replacement...

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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 OCABR guideline on inactivated COVID-19 vaccines

EDQM 04/05/2022 Strasbourg, France

The new Official Control Authority Batch Release (OCABR) “Guideline for Pandemic COVID-19 Vaccine, Inactivated”, 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 4 May 2022. The availability of...

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Council of Europe adopts recommendation on developing and optimising programmes for the donation of organs after the circulatory determination of death

EDQM 14/04/2022 Strasbourg, France

The Committee of Ministers of the Council of Europe adopted Recommendation CM/Rec(2022)3 on the development and optimisation of programmes for the donation of organs after the circulatory determination of death in February 2022. Each year thousands of patients die or endure poor quality of life...

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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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EDQM sticker no longer to appear on Certificates of suitability

EDQM 12/04/2022 Strasbourg, France

As of the 1 May 2022, the European Directorate for the Quality of Medicines & HealthCare (EDQM) sticker will no longer appear on Certificates of suitability to the European Pharmacopoeia monographs (CEPs). This adhesive sticker (see picture) will no longer be pasted on CEPs next to the wet...

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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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Public holidays: EDQM offices closed from 15 to 18 April 2022

EDQM 11/04/2022 Strasbourg, France

Due to public holidays in Alsace, France, the European Directorate for the Quality of Medicines & HealthCare (EDQM) will be closed from Friday 15 April to Monday 18 April 2022 included.

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Certification monthly report of activities: End of March 2022

EDQM 08/04/2022 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of March 2022 Certification Monthly Report For more information, access the Certification Database.

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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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CEP holders invited to comment on draft monographs published in Pharmeuropa 34.2

EDQM 07/04/2022 Strasbourg, France

Holders of Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs) are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 34.2. The table below lists the substances...

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EDQM helping increase tissue donation thanks to a better understanding of post-mortem blood testing practices

EDQM 07/04/2022 Strasbourg, France

Tissue from one deceased donor may be transplanted into as many as 100 individuals, improving their quality of life and even saving their lives (e.g. in the treatment of catastrophic burns). However, the use of tissues of human origin can result in unintentional transmission of disease. Such...

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