4 new Ph. Eur. reference standards and 16 replacement batches released in September 2022

New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Technical information 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...

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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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DCEP Sharing tool user guide revised

EDQM 04/10/2022 Strasbourg, France

The EDQM DCEP Sharing Tool was launched in January 2022 to ensure that EDQM documents could be shared securely between its Certification of Substances Department (DCEP) and CEP holders or applicants during the CEP lifecycle. This new version of the guide to creating and managing user accounts...

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Implementation of the European Pharmacopoeia Supplement 11.1 – Notification for CEP holders

EDQM 04/10/2022 Strasbourg, France

Supplement 11.1 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 April 2023, and to follow the...

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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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Council of Europe takes steps to support self-sufficiency in tissues and cells for human application and facilitate sharing of knowledge in this field

EDQM 28/09/2022 Strasbourg, France

The Committee of Ministers of the Council of Europe has adopted a recommendation encouraging member states to harmonise the collection of data on the availability and use of tissues and cells according to a predefined set of parameters and definitions. This text aims to support self-sufficiency...

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Newsletter Transplant 2022 shows a global increase in donation and transplantation figures, lessons learnt from COVID-19 pandemic

EDQM 27/09/2022 Strasbourg, France

The latest edition of the Newsletter Transplant – the international reference in monitoring practice in donation and transplantation of substances of human origin – has just been published. It provides comprehensive information and data on donation and transplantation activities in 2021 from 79...

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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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Become an “influencer for life”: 2022 edition of the European Day for Organ Donation and Transplantation encourages people to share what’s most precious

EDQM 20/09/2022 Strasbourg, France

The 2022 edition of the European Day for Organ Donation and Transplantation (EODD) will be hosted by Poland on 8 October 2022. The European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe has sponsored EODD in a different country every year since 1996. The...

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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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Certification monthly report of activities: End of August 2022

EDQM 09/09/2022 Strasbourg, France

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

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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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2 new Ph. Eur. reference standards and 5 replacement batches released in August 2022

EDQM 07/09/2022 Strasbourg, France

New Ph. Eur. reference standards Replacement batches for Ph. Eur. reference standards Removal Future removal Change of sales units Technical information 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...

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Revised OCABR Guideline for Pandemic COVID-19 vaccine (mRNA) now available

EDQM 07/09/2022 Strasbourg, France

The Guideline for Pandemic COVID-19 vaccine (mRNA), in force since 12 November 2020, has been updated to accommodate bivalent mRNA COVID-19 vaccines. The update includes a revision of the list of tests to be performed by Official Medicines Control Laboratories (OMCLs) for Official Control...

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Stakeholder consultation – Draft guidelines for medication review

EDQM 26/07/2022 Strasbourg, France

From 20 July to 23 September 2022, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is seeking the opinions of stakeholders on its draft guidelines for medication review. This consultation targets international organisations active in public health and social matters,...

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European Pharmacopoeia seeking user feedback on use of recombinant factor C for control of bacterial endotoxins in its water monographs

EDQM 05/09/2022 Strasbourg, France

General chapter 2.6.32. Test for bacterial endotoxins using recombinant factor C was published in Supplement 10.3 of the European Pharmacopoeia (Ph. Eur.) and came into force on 1 July 2021. This new general chapter describes a bacterial endotoxins test (BET) that can be used as an alternative to...

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New general chapter on implementation of pharmacopoeial procedures published in the 11th Edition of the European Pharmacopoeia

EDQM 02/09/2022 Strasbourg, France

A new general chapter, Implementation of pharmacopoeial procedures (5.26), has just been published in the 11th Edition of the European Pharmacopoeia (Ph. Eur.). The text was adopted by the Ph. Eur. Commission at its session in November 2021. This new general text elaborates on the requirement...

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Nitrosamines – Deadline extension for all CEP holders to complete step 3 Revision to the CEP (now 1 October 2023)

EDQM 04/08/2022 Strasbourg, France

The European medicines regulatory network has agreed to extend the deadline for submissions related to Step 3: variation to the marketing authorisation until 1 October 2023. This extension is intended to allow companies time to perform a thorough investigation and establish any required...

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