European Pharmacopoeia Supplement 11.4 now available

EDQM 03/10/2023 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Supplement 11.4 is now available and will be applicable in 39 European countries as of 1 April 2024. This volume is included in the 2024 subscription (11.3, 11.4 and 11.5) to the 11th Edition of the Ph. Eur. Subscriptions for print and/or electronic versions...

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Ph. Eur. allows the use of recombinant factor C for control of bacterial endotoxins in water monographs

EDQM 13/092023 Strasbourg, France

Revised versions of the widely used monographs, Water for injections (0169) and Purified water (0008), will be published in Supplement 11.4 of the European Pharmacopoeia (Ph. Eur.). Adopted by the Ph. Eur. Commission at its 175th session in March this year, these two fundamental texts now allow...

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N-nitrosamine impurities in Ph. Eur. monographs: update on approach

EDQM 24/07/2023 Strasbourg, France

Over the past few years, the texts of the European Pharmacopoeia (Ph. Eur.) have been adapted regularly to reflect the latest European regulatory requirements for N-nitrosamines. This included adding a Production statement covering the risk of N-nitrosamine formation to the Ph. Eur.’s five...

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Outcome of the 176th session of the European Pharmacopoeia Commission, June 2023

EDQM 05/07/2023 Strasbourg, France

The European Pharmacopoeia Commission (EPC) held its 176th session on 20 and 21 June 2023. The 67 texts adopted at this session by the EPC will be published in European Pharmacopoeia (Ph. Eur.) Supplement 11.5 (January 2024), with an implementation date of 1 July 2024. These 67 texts included 11...

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2022 Highlights – EDQM annual report now available

EDQM 05/06/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published its 2022 annual report, providing a comprehensive overview of its activities and achievements, and putting select data on the present state of EDQM/Council of Europe public health initiatives at your...

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Pharmeuropa 35.3 just released

EDQM 03/07/2023 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 35.3 is 30 September 2023.

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New Pharmeuropa Bio & Scientific Notes article now online: HCV RNA for NAT BRP replacement batch

EDQM 03/07/2023 Strasbourg, France

Following the successful completion of the Biological Standardisation Programme (BSP) study for the establishment of batch 2 of the Hepatitis C Virus (HCV) RNA for nucleic acid amplification techniques (NAT) Biological Reference Preparation (BRP), the outcome has been published in the online...

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European Pharmacopoeia Supplement 11.3 now available

EDQM 01/07/2023 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Supplement 11.3 is now available and will be applicable in 39 European countries as of 1 January 2024. This volume is included in the 2024 subscription (11.3, 11.4 and 11.5) to the 11th Edition of the Ph. Eur. Subscriptions for print and/or electronic...

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Over 100 excipient monographs now with an FRC section in the Ph. Eur.

EDQM 30/06/2023 Strasbourg, France

European Pharmacopoeia (Ph. Eur.) Supplement 11.2, which comes into force in 39 European countries on 1 July 2023, contains five excipient monographs that have been revised to include a section on functionality-related characteristics (FRCs), boosting the total of Ph. Eur. monographs that include...

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EDQM publishes 2nd edition of Herbal Guide

EDQM 07/06/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published a new edition of the Guide for the elaboration of monographs on herbal drugs and herbal drug preparations. This guide is invaluable for the authors of monographs on these substances, and also helps users...

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Ph. Eur. Commission keeps pace with veterinary vaccine development efforts

EDQM 02/06/2023 Strasbourg, France

The first DNA vaccine granted a marketing authorisation in the European Union (EU) dates back to 2016 and is intended to protect Atlantic salmon against salmon pancreas disease (SPD) caused by salmon alphavirus subtype 3. Veterinary vaccine manufacturers have been developing third generation...

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Call for Experts - NANO Working Party (Nanomedicines)

EDQM 01/06/2023 Strasbourg, France

In June 2022, the EDQM organised and hosted a symposium on “Quality requirements for nanomedicines – what role should the European Pharmacopoeia (Ph. Eur.) play?’’, during which the participants expressed a strong interest in having texts on nanomedicines available in the...

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European Pharmacopoeia welcomes Kyrgyz Republic as observer state

EDQM 31/05/2023 Strasbourg, France

The European Pharmacopoeia Commission has granted observer status to the Kyrgyz Republic. This decision demonstrates the dynamism of the European Pharmacopoeia (Ph. Eur.), which now has 32 observers from around the world in addition to 39 European countries and the European Union as signatory...

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Current options for shipping to Ukraine

EDQM 22/05/2023 Strasbourg, France

The EDQM is able to offer several options for shipments to Ukraine. Please consult the linked table: “EDQM shipping options for Ukraine”.

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PDG makes significant progress in its harmonisation efforts

EDQM 16/05/2023 Strasbourg, France

The Pharmacopoeial Discussion Group (PDG)¹ works to harmonise the technical content of selected excipient monographs and general chapters (more information here). An important step forward in the harmonisation effort has been achieved recently for a number of texts. New sign-offs Numerous texts...

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Ph. Eur. Commission kicks off elaboration of three general texts on mRNA vaccines and components

EDQM 05/05/2023 Strasbourg, France

Messenger RNA (mRNA) vaccines have been at the forefront of vaccine development efforts during the COVID-19 pandemic. With two authorised mRNA-based vaccines on the market, the mRNA vaccine field continues to evolve, as this increasingly important technology can be tailored to fight different...

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Pharmacopoeial Discussion Group achievements

EDQM 25/04/2023 Strasbourg, France

The Pharmacopoeial Discussion Group (PDG) held its interim videoconference on 15 March 2023.

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European Pharmacopoeia Supplements 11.3 to 11.5 – 2024 subscriptions now open!

EDQM 19/04/2023 Strasbourg, France

The 2024 subscriptions to the European Pharmacopoeia (Ph. Eur.), including the Supplements 11.3 to 11.5, are now available for purchase in the WebStore of the European Directorate for the Quality of Medicines & HealthCare (EDQM). Two subscription formats are available. Both include access to all...

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Public consultation on new general chapter on phage therapy active substances and medicinal products for human and veterinary use in Pharmeuropa 35.2

EDQM 06/04/2023 Strasbourg, France

At its 170th session (June 2021), the European Pharmacopoeia Commission (EPC) agreed to elaborate a new general chapter, Phage therapy active substances and medicinal products for human and veterinary use (5.31), and assigned the task to the newly created Bacteriophages Working Party (BACT WP)....

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Outcome of the 175th session of the European Pharmacopoeia Commission, March 2023

EDQM 06/04/2023 Strasbourg, France

The European Pharmacopoeia Commission (EPC) held its 175th session on 21 and 22 March 2023. The 84 texts adopted by the EPC at this session will be published in European Pharmacopoeia (Ph. Eur.) Supplement 11.4 (October 2023), with an implementation date of 1 April 2024. These 84 texts included...

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