24 replacement batches released in January 2023

03/02/2023 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 European Directorate for the Quality of...

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Certification monthly report of activities: End of January 2023

EDQM 03/02/2023 strasbourg, france

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of January 2023 Certification Monthly Report For more information, access the Certification Database.

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Ph. Eur. launches public consultation on two chapters on pharmaceutical technology procedures

EDQM 01/02/2023 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) contains quality standards that are applied in a constantly evolving environment and it is therefore essential that its texts and the procedures they describe consistently reflect current practices. As is the case for any other text, where procedures relating...

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SNOMED International and the EDQM collaborate on map development

EDQM 31/01/2023 Strasbourg, France

SNOMED International and the European Directorate for the Quality of Medicines & HealthCare (EDQM), Council of Europe, have signed an agreement governing the creation, maintenance and distribution of a map between both organisations’ terminologies. The agreement came into effect in September...

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CEP holders – How to submit a nitrosamine risk assessment

EDQM 30/01/2023 Strasbourg, France

To facilitate the acceptance of proposed changes in a timely manner, the European Directorate for the Quality of Medicines & HealthCare (EDQM) would like to draw the attention of CEP holders to the following details regard minor revisions. Minor revisions should be submitted for revised...

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European Paediatric Formulary: Simple syrup (preservative-free) monograph published

EDQM 25/01/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has added a new monograph, Simple syrup (preservative-free), to the European Paediatric Formulary. The monograph was published in Issue 4 of Pharmeuropa PaedForm in January 2022, approved by the European Pharmacopoeia...

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Implementation of the European Pharmacopoeia Supplement 11.2 – Notification for CEP holders

EDQM 20/01/2023 Strasbourg, France

Supplement 11.2 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 July 2023, and to follow the...

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Call for experts – Aluminium in parenteral nutrition solutions

EDQM 19/01/2023 Strasbourg, France

Although certain European countries already regulate aluminium in parenteral nutrition solutions (PNS), there are currently no European standards limiting the maximum amount of aluminium in these solutions, which are often prepared extemporaneously. To address this situation, the European...

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User satisfaction survey: revamped EDQM website

EDQM 18/01/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) launched its new website on 1 April 2022, over nine months ago. At this point, you have had the time to explore what the new website has to offer, so the EDQM is seeking your feedback through an anonymous user satisfaction...

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CEP holders invited to comment on draft monographs published in Pharmeuropa 35.1

EDQM 10/01/2023 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 35.1. The table below lists the substances...

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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 06/01/2022 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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Management of EDQM CEP documents: EDQM introduces a consultation phase

EDQM 04/01/2023 Strasbourg, France

The EDQM has updated its policy for the elaboration of documents related to the Certification of Suitability (CEP) procedure. Detailed information on the types of documents and the different steps in the elaboration process can be found here. The elaboration process for CEP documents is placed...

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Certification monthly report of activities: End of December 2022

EDQM 03/01/2023 Strasbourg, France

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

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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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Information for CEP applicants - EDQM-DCEP non-working days in 2023

EDQM 02/01/2023 Strasbourg, France

In order to facilitate the calculation of the timelines as described in the policy document “Management of applications for new Certificates of Suitability, Requests for Revision or Renewal of Certificates of Suitability and applications using the ‘sister files’ procedure” (PA-PH-CEP (13) 110,...

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1 new Ph. Eur. reference standards and 13 replacement batches released in December 2022

EDQM 02/01/2023 Strasbourg, France

The EDQM announces the release of 1 new European Pharmacopoeia (Ph. Eur.) reference standard and 13 replacement batches.

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European Paediatric Formulary: Chloral Hydrate Oral Solution monograph open for public consultation in Pharmeuropa PaedForm

EDQM 21/12/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 5 of Pharmeuropa PaedForm, in which the draft text for Chloral hydrate 100 mg/mL Oral Solution is published for public consultation prior to its inclusion in the European Paediatric Formulary. The...

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Joint EDQM–EPAA hybrid event on the future of pyrogenicity testing – Programme now available

EDQM 15/12/2022 BRUSSELS, BELGIUM & ONLINE

In June 2021, the European Pharmacopoeia (Ph. Eur.) Commission decided to undertake the replacement of the rabbit pyrogen test (RPT) in the Ph. Eur. within approximately five years. This decision affects several Ph. Eur. texts in a wide range of fields. In light of these developments, a three-day...

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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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Deadline extended to 13 January 2023 - Contribute to shaping the future EDQM strategy – Stakeholder survey

EDQM 23/11/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is conducting a survey to seek the input of its stakeholders, including the (wider) public. Your input will help shape our upcoming four-year strategy (2024-2027) and contribute to ensuring the EDQM continuously meets your...

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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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EDQM releases new edition of the Tissue and Cells Guide, providing state-of-the-art guidance for healthcare professionals

EDQM 15/12/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published the 5th edition of the Guide to the quality and safety of tissues and cells for human application. The updated guide provides a comprehensive overview of the most recent advances in the field, as well as...

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Certification monthly report of activities: End of November 2022

EDQM 15/12/2022 Strasbourg, France

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

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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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How CEP holders can avoid the rejection of notifications

EDQM 09/12/2022 Strasbourg, France

In order to facilitate the acceptance of proposed changes in a timely manner, CEP holders are reminded that the European Directorate for the Quality of Medicines & HealthCare (EDQM) Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia...

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5 new Ph. Eur. reference standards and 12 replacement batches released in November 2022

EDQM 06/12/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) announces the release of 5 new European Pharmacopoeia (Ph. Eur.) reference standards.

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“Polypharmacy and ageing” – EDQM participation in ESCP symposium in Prague

EDQM 15/11/2022 Strasbourg, France

Representatives of the European Directorate for the Quality of Medicines & HealthCare (EDQM) participated in the 50th European Society of Clinical Pharmacy (ESCP) Symposium, entitled “Polypharmacy and ageing – individualized, person-centered care”, held in Prague from 19 to 21 October 2022....

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Full OCABR guideline for Pandemic COVID-19 vaccine, Inactivated, now available

EDQM 29/11/2022 Strasbourg, France

The guideline for Pandemic COVID-19 vaccine, Inactivated, in force since 4 May 2022, contains the list of tests to be carried out by an Official Medicines Control Laboratory (OMCL) for Official Control Authority Batch Release (OCABR). It has now been updated to include a model protocol for the...

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EDQM order and shipment deadlines and end-of-year closure

EDQM 15/11/2022 Strasbourg, France

Order and shipment deadlines have been established for publications and reference standards, taking into account the closure of the European Directorate for the Quality of Medicines & HealthCare (EDQM) offices from 22 December 2022 (12 noon CET) to 2 January 2023 (8 a.m. CET). The dates by type...

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European Paediatric Formulary: Revised Phosphate Oral Solution monograph published

EDQM 15/11/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published the revised monograph Phosphate 60 mg/mL Oral Solution in the European Paediatric Formulary (PaedForm). This revised monograph (the first PaedForm text to undergo revision) was published in Issue 4 of...

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Certification monthly report of activities: End of October 2022

EDQM 08/11/2022 Strasbourg, France

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

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7 new Ph. Eur. reference standards and 14 replacement batches released in October 2022

EDQM 03/11/2022 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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The Council of Europe/EDQM and the European Union conclude an agreement expanding the scope of their co-operation in the field of substances of human origin

EDQM 28/10/2022 Strasbourg, France

The Council of Europe/European Directorate for the Quality of Medicines & HealthCare (EDQM) and the European Union (EU), through the European Commission, have concluded a new contribution agreement, with equal financing, which will run until 2024. This agreement further enhances their already...

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“CEP of the future”: second project update

EDQM 21/10/2022 Strasbourg, France

Since conducting a wide public survey on the Certification of suitability to the European Pharmacopoeia monographs (CEP), the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been working on the design of the CEP of the future. Different aspects were presented to...

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CEP holders invited to comment on draft monographs published in Pharmeuropa 34.4

EDQM 21/10/2022 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 34.4. The table below lists the substances...

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EDQM changes CEP policy regarding chemical applications for polymorphs

EDQM 18/10/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has recently modified its policy on chemical applications for polymorphs. A request for a Certificate of suitability to the European Pharmacopoeia monographs (CEP) for a specific polymorphic form (as a grade) is now...

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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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Certification monthly report of activities: End of September 2022

EDQM 07/10/2022 Strasbourg, France

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

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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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European Day for Organ Donation and Transplantation 2022 – Become an “influencer for life” and share what’s most precious

EDQM 07/10/2022 Strasbourg, France

In recent years, great strides have been made in the field of organ, tissue and cell transplantation and human application, making it one of the great medical success stories of modern times. Transplantation is in many cases the only viable treatment for reclaiming essential functions and...

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EDQM publishes booklet on human tissue donation

EDQM 06/10/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published a booklet on the important matter of human tissue donation. It provides clear, accurate and balanced information to help readers make informed, responsible decisions on tissue donation, in accordance with...

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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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Ph. Eur. survey for the availability of alternative plasticisers to DEHP in containers for aqueous solutions for intravenous infusion in authorised medicinal products

EDQM 23/08/2022 Strasbourg, France

Due to a change in the REACH Regulation ((EC) N° 1907/2006) introduced in November 2021, the experts of the European Pharmacopoeia (Ph. Eur.) have been considering replacing the plasticiser DEHP (bis(2-ethylhexyl)phthalate), described as plastic additive 01 in Ph. Eur. general chapter 3.1.14....

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11th edition of the European Pharmacopoeia now available in print

EDQM 17/08/2022 Strasbourg, France

The 11th Edition of the European Pharmacopoeia (Ph. Eur.) is now available in print version. Don’t delay, order your subscription now! This latest edition contains numerous revised and new texts, reflecting the latest scientific and technological progress and regulatory developments in the...

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Call for experts: join the Ph. Eur. network

EDQM 10/08/2022 Strasbourg, France

Pharmaceutical analytical procedures related to quality control methods for antibiotics

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The European Pharmacopoeia Commission elects its two new Vice Chairs

EDQM 10/08/2022 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission is pleased to announce the nomination of two new Vice Chairs, elected at its 173rd session held on 22 and 23 June 2022. Dr Eugenia Cogliandro (first Vice Chair) and Dr Marija Malesevic (second Vice Chair), replace outgoing Vice Chairs Prof. S....

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Certification monthly report of activities: End of July 2022

EDQM 08/08/2022 Strasbourg, France

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

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Ph. Eur. Commission establishes a new working party on mRNA vaccines

EDQM 03/08/2022 Strasbourg, France

At its 173rd session in June 2022, the European Pharmacopoeia (Ph. Eur.) Commission decided to start working on mRNA vaccines by establishing the mRNAVAC Working Party, entrusted with elaborating quality standards supporting this emerging field that will be included in the Ph. Eur. The newly...

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3 new Ph. Eur. reference standards and 23 replacement batches released in July 2022

EDQM 01/08/2022 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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General chapter 2.2.46. Chromatographic separation techniques now published in Ph. Eur. 11th Edition

EDQM 27/07/2022 Strasbourg, France

General chapter 2.2.46. Chromatographic separation techniques has been revised to incorporate the provisions of the pharmacopoeial harmonisation text, signed-off by the Pharmacopoeial Discussion Group (PDG) on 28 September 2021. The revised chapter is now available in the 11th Edition of the...

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Call for experts: join the Ph. Eur. network

EDQM 18/07/2022 Strasbourg, France

Quality control of medicinal products containing chemically defined active substances and of the corresponding active substances contained in such medicinal products

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Ph. Eur. Human immunoglobulin for electrophoresis BRP batch 4 – outcome of establishment study published online

EDQM 18/07/2022 Strasbourg, France

Following the adoption of batch 4 of the European Pharmacopoeia Biological Reference Preparation (Ph. Eur. BRP) for human immunoglobulin for electrophoresis by the Ph. Eur. Commission, the outcome of the establishment study has been published in Pharmeuropa Bio & Scientific Notes, a freely...

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15 replacement batches released in June 2022

EDQM 15/07/2022 Strasbourg, France

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 order The European Directorate for...

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Draft legislative proposal for a new EU Regulation on Blood, Tissues and Cells

EDQM 15/07/2022 Strasbourg, France

On 14 July 2022, the European Union (EU) Commission issued its draft legislative proposal for a new EU Regulation on Blood, Tissues and Cells (BTC), in which the EU Commission proposes to leverage on the technical standards and proven expertise of the European Centre for Disease Prevention and...

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EDQM publishes 8th edition of the Guide to the quality and safety of organs for transplantation

EDQM 13/07/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just published the 8th edition of the Guide to the quality and safety of organs for transplantation. The updated guide provides practical guidance to all professionals in the field, as well as technical guidance to...

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Certification monthly report of activities: End of June 2022

EDQM 13/07/2022 Strasbourg, France

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

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What’s new for homoeopathic preparations at European level?

EDQM 11/07/2022 Strasbourg, France

First revision of the Guide for the elaboration of monographs on homoeopathic preparations (Edition 2022) As announced in the press release dated 11 April 2022, the European Pharmacopoeia (Ph. Eur.) Commission approved the revised version of the Guide for the elaboration of monographs on...

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Outcome of the 173rd session of the European Pharmacopoeia Commission, June 2022

EDQM 05/07/2022 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Commission held its 173rd session on 21 and 22 June 2022. Forty-eight texts were adopted and will be published in Ph. Eur. Supplement 11.2, effective as of 1 July 2023. Of these 48 texts, four were new monographs: Pumpkin seed (2941), Propylene glycol...

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New edition of the Technical Guide for the elaboration of Ph. Eur. monographs ready for publication

EDQM 07/07/2022 Strasbourg, France

At its 173rd session, the European Pharmacopoeia Commission approved the publication of a new edition of the Technical Guide for the elaboration of monographs. This guide is an essential aid both to the drafting of monographs and for the transposition of analytical techniques into a...

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Pharmeuropa 34.3 just released

EDQM 07/07/2022 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 34.3 is 30 September 2022. Users and interested parties are welcome to comment on these drafts. It...

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Implementation of the 11th Edition of European Pharmacopoeia – Notification for CEP holders

EDQM 07/07/2022 Strasbourg, France

The 11th Edition 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 January 2023, and to follow the...

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CEP holders invited to comment on draft monographs published in Pharmeuropa 34.3

EDQM 05/07/2022 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 34.3. The table below lists the substances...

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Revision of Heparin sodium (0333) and Heparin calcium (0332) monographs – feedback required

EDQM 30/06/2022 Strasbourg, France

First published in the 1980s, the monographs on unfractionated heparin are some of the earliest texts of the European Pharmacopoeia (Ph. Eur.). Since then, significant effort has been expended by the Ph. Eur. experts to regularly revise these texts, with the most significant series of revisions...

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OMCL Annual Meeting 2022: European Strategies for Work Sharing and Collaboration in Testing of Medicines

EDQM 29/06/2022 Strasbourg, France

The 27th Annual Meeting of the European Network of Official Medicines Control Laboratories (OMCLs) was held from 13 to 17 June 2022 at the Council of Europe, in Strasbourg (France). Over 230 participants – from 36 countries and representing 60 OMCLs – attended this meeting organised by the...

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Pharmacopoeial Discussion Group videoconference meeting

EDQM 28/06/2022 Strasbourg, France

The Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia with WHO as observer, held its interim videoconference in two sessions on 15 and 28 March 2022. During this videoconference, the PDG discussed...

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BSP study publication: Somatropin/desamidosomatropin resolution mixture CRS 2

EDQM 27/06/2022 Strasbourg, France

An article on the outcome of the Biological Standardisation Programme (BSP) study for the establishment of the European Pharmacopoeia (Ph. Eur.) Somatropin/desamidosomatropin resolution mixture Chemical Reference Substance batch 2 is now available free online. The article has been published in...

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Call for experts: join the Ph. Eur. network

EDQM 23/06/2022 Strasbourg, France

Quality control of inorganic substances and synthetic and semi-synthetic organic substances

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EDQM ISO 9001:2015 certification renewed

EDQM 24/06/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) successfully obtained the renewal of its certification according to the ISO 9001:2015 standard from the AFNOR certification body, confirming the compliance of the Quality Management System of the EDQM with this standard....

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NEW 5th European Training Course on Quality Management for Blood Establishments

EDQM Registration closing date: 15 July 2022 online

The European Directorate for the Quality of Medicines & HealthCare (EDQM)/Council of Europe (CoE) is organising a FREE training course on audit practices for blood establishments, with the support of the European Commission. Auditing, in addition to being a key driver in the continual improvement...

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Pharmeuropa Bio & Scientific Notes now accessible without registration

EDQM 14/06/2022 Strasbourg, France

Pharmeuropa Bio & Scientific Notes, a free online journal of the European Directorate for the Quality of Medicines & HealthCare (EDQM) indexed in Medline/PubMed®, can be consulted without prior registration as of 13 June 2022. The journal seeks to disseminate knowledge on methods of analysis...

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2021 Highlights – EDQM annual report now available

EDQM 14/06/2022 Strasbourg, France

Download: 2021 Highlights – EDQM annual report 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...

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New option for shipments to Ukraine and the Republic of Moldova

EDQM 13/06/2022 Strasbourg, France

The EDQM is now able to offer a new option for shipments to Ukraine and the Republic of Moldova. Ukrainian and Moldovan users will receive a dedicated e-mail explaining how to proceed. If you would like more information, please contact us through our HelpDesk.

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Certification monthly report of activities: End of May 2022

EDQM 08/06/2022 Strasbourg, France

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

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16 replacement batches released in May 2022

EDQM 07/06/2022 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 European Directorate for the Quality of Medicines...

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OMCLs participate in international regulatory collaboration on the analysis of nitrosamines in metformin‑containing medicines

EDQM 31/05/2022 Strasbourg, France

In 2020, batches of metformin-containing medicines were recalled because they contained N-nitrosodimethylamine (NDMA), a probable human carcinogen, above the acceptable daily intake (AI) of 96 ng/day. Prior to the recalls, Official Medicines Control Laboratories (OMCLs) from the OMCL Network...

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