Outcome of the 174th session of the European Pharmacopoeia Commission, November 2022

EDQM 09/01/2023 Strasbourg, France

The European Pharmacopoeia Commission (EPC) held its 174th session on 22 and 23 November 2022. The 85 texts adopted by the Commission at this session will be published in European Pharmacopoeia (Ph. Eur.) Supplement 11.3 (July 2023), with an implementation date of 1 January 2024. These 85 texts...

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Ph. Eur. Commission welcomes Ethiopian FDA as observer

EDQM 09/01/2023 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission granted observer status to the Ethiopian Food and Drug Administration (EFDA) during its 174th session (November 2022). This decision demonstrates the dynamism of the European Pharmacopoeia, which now has 31 observers from around the world, in...

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Ph. Eur. Commission adopts revised general monographs 2034 and 2619 after inclusion of new paragraph on control of N-nitrosamines

EDQM 06/01/2023 Strasbourg, France

At its 174th session in November 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted the revised general monographs Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619), which now include a paragraph explaining the Ph. Eur. approach to N-nitrosamine...

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Pharmacopoeial Discussion Group achievements

EDQM 06/01/2023 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), with the World Health Organization (WHO) as observer, held its annual autumn meeting from 18 to 21 October 2022. Due to...

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Pharmeuropa 35.1 just released

EDQM 03/01/2023 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 35.1 is 31 March 2023.

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Revised general chapter on rubber closures published in the Ph. Eur. Supplement 11.1

EDQM 19/12/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the revised general chapter on Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders (3.2.9) in European Pharmacopoeia Supplement 11.1, with an...

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European Pharmacopoeia Supplement 11.2 now available

EDQM 16/12/2022 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Supplement 11.2 is now available and will be applicable in 39 European countries as of 1 July 2023. This volume is included in the 2023 subscription (11.0, 11.1 and 11.2) to the 11th Edition of the Ph. Eur. Subscriptions for print and/or electronic versions...

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Signal-to-noise ratio: revision of Ph. Eur. general chapter Chromatographic separation techniques (2.2.46)

EDQM 14/12/2022 Strasbourg, France

The revised general chapter Chromatographic separation techniques (2.2.46) was published in the 11th Edition of the European Pharmacopoeia (Ph. Eur.) in the framework of international harmonisation. This new version (due to be implemented on 1 January 2023) includes many important changes. One of...

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Ph. Eur. publishes Cannabis flos draft monograph in Pharmeuropa for comment

EDQM 13/10/2022 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) is seeking feedback on its new draft monograph on Cannabis flos (3028). The draft text covers the herbal drug defined as dried, whole or fragmented, fully developed shoot apices of female cultivars of Cannabis sativa L. It is to be read in conjunction with...

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General chapter 2.2.46. Chromatographic separation techniques: comparison of requirements in the Ph. Eur. 10th and 11th Editions

EDQM 13/10/2022 Strasbourg, France

A new document has been added to the Knowledge database page for revised general chapter 2.2.46, under Additional information. This document provides a useful and easy reference guide to the main changes made to the general chapter recently published in the 11th Edition of the European...

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Ph. Eur. publishes key harmonised monographs on Paraffin, white soft and Paraffin, yellow soft

EDQM 12/10/2022 Strasbourg, France

The recently published (July 2022) 11th Edition of the European Pharmacopoeia (Ph. Eur.) includes the two revised harmonised monographs Paraffin, white soft (1799), and Paraffin, yellow soft (1554). The publication of these two texts marks an important step forward in the international...

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Pharmeuropa 34.4 just released

EDQM 11/10/2022 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 34.4 is 31 December 2022. Users and interested parties are welcome to comment on these drafts. It should...

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The EDQM participated in a conference on Next Generation Sequencing

EDQM 07/10/2022 Strasbourg, France

On 27-28 September, representatives of the EDQM participated in the 3rd Conference on Next Generation Sequencing for Adventitious Virus Detection in Biologics for Humans and Animals organised by the International Alliance for Biological Standardization (IABS) in Rockville, Maryland, U.S.A. At the...

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Revised general chapter on chemometrics published in Supplement 11.1 of the European Pharmacopoeia

EDQM 05/10/2022 Strasbourg, France

The revised general chapter, Chemometric methods applied to analytical data (5.21), has just been published in Supplement 11.1 of the European Pharmacopoeia (Ph. Eur.). The text was adopted by the Ph. Eur. Commission at its 172nd Session in March 2022. Published for information, this general...

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European Pharmacopoeia 11th Edition conference outcomes

EDQM 03/10/2022 Strasbourg, France

Organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM), the European Pharmacopoeia 11th Edition Conference, “Collaboration, Innovation and Scientific Excellence”, took place in Strasbourg from 19 to 21 September 2022. Held in hybrid format, the event brought...

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European Pharmacopoeia Supplement 11.1 now available

EDQM 23/09/2022 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Supplement 11.1 is now available and will be applicable in 39 European countries as of 1 April 2023. This volume is included in the 2023 subscription (11.0, 11.1 and 11.2) to the 11th Edition of the Ph. Eur. Subscriptions for online and/or print versions are...

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Indian Pharmacopoeia Commission to be represented at EDQM international conference in Strasbourg

EDQM 15/09/2022 Strasbourg, France

The Indian Pharmacopoeia Commission (IPC) will take part in the international conference entitled “Collaboration, Innovation and Scientific Excellence: the European Pharmacopoeia 11th Edition”, organised by the European Directorate for the Quality of Medicines & HealthCare (EDQM) and to take...

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Call for experts: join the Ph. Eur. network

EDQM 09/09/2022 Strasbourg, France

Quality control methods for biological and biotechnological substances and products

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PDG welcomes Indian Pharmacopoeia Commission to pilot for global expansion

EDQM 09/09/2022 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), with the World Health Organization (WHO) as an observer, is delighted to welcome the Indian Pharmacopoeia Commission...

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New FAQ on EDQM HelpDesk: Ph. Eur. revised general chapter 2.2.46. Chromatographic separation techniques

EDQM 08/09/2022 Strasbourg, France

Following queries received from users through the EDQM HelpDesk, new FAQs on the application of revised general chapter 2.2.46. Chromatographic separation techniques (11.0) has been added to the existing series of FAQs dealing with the European Pharmacopoeia & International harmonisation. This is...

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