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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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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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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Tools to support contingency and emergency planning for blood systems

EDQM 06/04/2022 Strasbourg, France

In emergency situations, it is vital to ensure a safe and adequate supply of blood for all essential transfusions. Join our Webinar to learn more! The Blood Supply Contingency and Emergency Plan (B-SCEP) Project was launched by the European Directorate for the Quality of Medicines & HealthCare...

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13 replacement batches released in March 2022

EDQM 06/04/2022 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...

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New EDQM website, redesigned to better serve your needs – Now online!

EDQM 01/04/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just launched its redesigned website. Discover the following new features. Improved, user-friendly navigation by main topics. This means faster access – in fewer clicks – to the information you need using the top menu...

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Pharmeuropa 34.2 just released

EDQM 04/04/22 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 34.2 is 30 June 2022. Users and interested parties are welcome to comment on these drafts. It should be...

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Metals and alloys used in food contact materials and articles: updated technical guide released for consultation

EDQM 21/03/2022 Strasbourg, France

The 1st edition of the technical guide “Metals and alloys used in food contact materials and articles” (2013) has been completely reviewed by the European Committee for Food Contact Materials and Articles (Partial Agreement) (CD-P-MCA) to account for regulatory developments and recent risk...

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Ph. Eur. to launch survey for the use of total organic carbon (TOC) test as a replacement of oxidisable substances test in Water for injections

EDQM 17/03/2022 Strasbourg, France

The experts of the European Pharmacopoeia (Ph. Eur.) are considering replacing the test for oxidisable substances by the test for total organic carbon (TOC) in the Tests section of the “Sterilised water for injections” part of the monograph on Water for injections (0169). This change has been...

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EDQM event "Quality requirements for nanomedicines"

EDQM 11/03/2022 Strasbourg, France

The COVID-19 pandemic and the emergence of mRNA vaccines have highlighted the importance of nanoparticle formulations – especially lipid-based systems – used for nucleic acid-based APIs. The success of SARS-CoV-2 vaccination programmes around the globe has demonstrated that these...

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Certification monthly report of activities: End of February 2022

EDQM 11/03/22 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. End of February 2021 Certification Monthly Report For more information, access the Certification Database.

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Full OCABR Guideline for Pandemic COVID-19 vaccine (Recombinant Spike Protein) now available

EDQM 08/03/2022 Strasbourg, France

The Pandemic COVID-19 vaccine (Recombinant Spike Protein) guideline, in force since 30 November 2021, 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 been updated to include a model...

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SAVE THE DATE! Conference celebrating the publication of the 11th Edition of the European Pharmacopoeia (19-21 September 2022)

EDQM 04/03/2022 STRASBOURG, FRANCE

After almost two years of online events, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is eager to announce the organisation of an international conference to celebrate the publication of the 11th Edition of the European Pharmacopoeia (Ph. Eur.). This in-person event...

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20 replacement batches released in February 2022

EDQM 03/03/2022 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...

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Suspension of shipments

EDQM 02/03/2022 STRASBOURG, FRANCE

Due to the recent events in Ukraine, all carriers have suspended their activities in Belarus, Moldova, Russia and Ukraine until further notice. Therefore, the EDQM can no longer proceed with any shipments for Reference Standards, Publications or PTS to these countries.

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Update of application forms for Certificate of Suitability applications

02/03/2022 STRASBOURG, FRANCE

The forms for the submission of Certificate of Suitability to the European Pharmacopoeia monographs (CEP) applications (new applications, revisions and sister files) have been updated in order to facilitate their handling and the transfer of the collected data in the new IT tools implemented at...

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EDQM remote inspections: from pilot phase to a permanent element of EDQM’s inspection scheme!

EDQM 23/02/2022 STRASBOURG, FRANCE

In March 2020 travel restrictions, designed to minimise the spread of SARS-CoV-2, interrupted the inspection programme of the European Directorate for the Quality of Medicines & HealthCare (EDQM), which monitors compliance with both Good Manufacturing Practice (GMP) and applications for...

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Webinar: How to communicate efficiently with the EDQM on CEP applications

EDQM 21/02/2022 Strasbourg, France

In October 2021, the CEP Department of the EDQM started using a new IT application for the management of its activities. The implementation of this new tool entailed specific changes in the way the EDQM communicates with applicants for Certificates of Suitability to the European Pharmacopoeia...

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New Webinar: What has changed in the Ph. Eur. General Notices?

EDQM 18/02/2022 Strasbourg, France

The General Notices is the European Pharmacopoeia (Ph. Eur.) go-to chapter that contains important information applicable to all Ph. Eur. texts. Its content is relevant for any user seeking to understand not just the conventional expressions and terminology used throughout the Ph. Eur. but also...

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Ph. Eur. Commission adopts harmonised general chapter 2.2.46. Chromatographic separation techniques

EDQM 15/02/2022 Strasbourg, France

At its 171st session in November 2021, the European Pharmacopoeia (Ph. Eur.) Commission adopted a new version of one of its widely used general chapters, Chromatographic separation techniques (2.2.46). The text has been revised to take account of the pharmacopoeial harmonisation text, signed-off...

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Certification monthly report of activities: End of January 2022

EDQM 11/02/2022 Strasbourg, France

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

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Ph. Eur. tentative policy on assay RSDs for monographs on medicinal products containing chemically defined active substances – End of trial period postponed

EDQM 09/02/2022 Strasbourg, France

When the experimental results allow, draft monographs will be published in Pharmeuropa with a peak area repeatability requirement of RSD ≤ 1.0% (n=6) determined on a solution containing the active substance CRS. The trial period for this policy has been prolonged until the end of February 2023,...

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EDQM reminds CEP holders of their responsibilities towards their customers

EDQM 03/02/2022 Strasbourg, France

CEP holders have obligations towards the marketing authorisation holders in order to enable them to fulfil their respective legal responsibilities. Recent issues have demonstrated the lack of knowledge of some CEP holders regarding those obligations. In order to clarify the issue, EDQM has...

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2 new reference standard and 19 replacement batches released in January 2022

EDQM 02/02/2022 Strasbourg, France

New Ph. Eur. reference standards 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...

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EDQM OCCL study reports low compliance of “kids’ cosmetics”

EDQM 02/02/2022 Strasbourg, France

A study by the European Network of Official Cosmetics Control Laboratories (OCCLs) indicates that “kids’ cosmetics” continue to fail to comply with European quality and safety regulations, finding that 25% of samples were non-compliant with legislative requirements. Decorative cosmetics,...

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How to use the EDQM DCEP sharing tool

EDQM 31/01/2022 Strasbourg, France

The EDQM DCEP sharing tool is a new IT tool used to ensure the secure sharing of EDQM documents between the EDQM Certification of Substances Department (DCEP) and CEP holders or applicants during the CEP lifecycle. Specific instructions are given to the intended users for the creation and the...

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Implementation of the European Pharmacopoeia Supplement 10.8 – Notification for CEP holders

EDQM 21/01/2022 Strasbourg, France

Supplement 10.8 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 2022, and to follow the...

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CEP holders invited to comment on draft monographs published in Pharmeuropa 34.1

EDQM 20/01/2022 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 34.1. The table below lists the substances...

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European Paediatric Formulary: two draft texts released for public consultation

EDQM 14/01/2022 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has just released Issue 4 of Pharmeuropa PaedForm, which contains two texts for public consultation, Simple syrup (preservative-free) and Phosphate 60 mg/mL Oral solution, prior to their inclusion in the European Paediatric...

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All you ever wanted to know about procedure 4 but never dared ask!

EDQM 14/01/2022 Strasbourg, France

This document is intended to help stakeholders understand the advantages of applying for a monograph elaboration via procedure 4. It describes how Group P4 has elaborated P4 monographs over the last 10 years. It also applies to monographs on biotherapeutics as elaborated by the P4bio Working...

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New for non-liquid, non-parenterally administered veterinary vaccines: maximum bioburden limit replaces sterility requirements

EDQM 13/01/2022 Strasbourg, France

Sterility requirements in non-liquid and non-parenterally administered veterinary vaccine monographs have been replaced by a maximum bioburden limit to allow the development of new innovative vaccine presentation forms while maintaining the same safety guarantees. The revised sterility...

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OMCL fingerprint studies on omeprazole and sildenafil API samples published in scientific journals – Update

EDQM 11/01/2022 Strasbourg, France

The Active Pharmaceutical Ingredient (API) Working Group of the General European OMCL Network (GEON) has conducted two market surveillance studies on omeprazole and sildenafil, the results of which have been published in the Journal of Pharmaceutical and Biomedical Analysis, Vol. 208 (2021)...

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Certification monthly report of activities: End of December 2021

EDQM 10/01/2022 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. December 2021 Certification Monthly Report For more information, access the Certification Database.

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Revised Colony-forming cell assay for human haematopoietic progenitor cells (2.7.28) and Nucleated cell count and viability (2.7.29) in Pharmeuropa 34.1

EDQM 10/01/2022 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapters Colony-forming cell assay for human haematopoietic progenitor cells (2.7.28) and Nucleated cell count and viability (2.7.29), published in this quarter’s issue of Pharmeuropa (34.1) for comment...

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3 new reference standards and 11 replacement batches released in December 2021

EDQM 07/01/2022 Strasbourg, France

New Ph. Eur. reference standards 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...

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“CEP of the future”: project update

EDQM 06/01/2022 Strasbourg, France

The consultation phase of the project to design the Certificate of suitability to the monographs of the European Pharmacopoeia (CEP) of the future has been completed. The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the survey outcome and a roadmap for...

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Pharmeuropa 34.1 just released

EDQM 05/01/2022 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 34.1 is 31 March 2022. Users and interested parties are welcome to comment on these drafts. It should be...

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Veterinary batch release network welcomes VMD, UK, as an observer

EDQM 22/12/2021 Strasbourg, France

The Veterinary Batch Release Network (VBRN) for immunological veterinary medicinal products (IVMPs) and the Veterinary Medicines Directorate (VMD), UK, have signed a memorandum of understanding (MOU) to renew the exchange and collaboration on common activities related to batch release of IVMPs...

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BSP study outcomes published in Pharmeuropa Bio & Scientific Notes

EDQM 21/12/2021 Strasbourg, France

Upon conclusion of a Biological Standardisation Programme (BSP) study, the outcome is made available in Pharmeuropa Bio & Scientific Notes providing readers with useful information regarding the method(s) used and, where appropriate, the value assignment of the established reference standard....

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European Pharmacopoeia Supplement 10.8 now available

EDQM 15/12/2021 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Supplement 10.8 is now available and will be applicable in 39 European countries as of 1 July 2022. This volume is included in the 2022 subscription (10.6, 10.7 and 10.8) to the 10th Edition of the Ph. Eur. Subscriptions for print and/or electronic versions...

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Certification monthly report of activities: October & November 2021

EDQM 14/12/2021 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. October & November 2021 Certification Monthly Report For more information, access the Certification Database.

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New-format order confirmation for reference standards and publications

EDQM 10/12/2021 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has updated its order confirmations to make them easier to read, including clearly identifying: the estimated shipping date for each product; any information the EDQM needs from you in order to ship your order; if your...

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Outcome of the 171st session of the European Pharmacopoeia Commission, November 2021

EDQM 06/12/2021 Strasbourg, France

The 171st session of the European Pharmacopoeia (Ph. Eur.) Commission took place on 23 and 24 November 2021. At this session, the Commission adopted 75 texts for publication in the 11th Edition of the European Pharmacopoeia: 66 revised texts and nine new texts, including: the revised and...

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13 replacement batches released in November 2021

EDQM 03/12/2021 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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Journal of Pharmaceutical and Biomedical Analysis publishes results of the OMCL fingerprint study on omeprazole API samples

EDQM 02/12/2021 Strasbourg, France

The Active Pharmaceutical Ingredient (API) Working Group of the General European OMCL Network (GEON) has conducted a market surveillance study on omeprazole, the results of which have been published in the Journal of Pharmaceutical and Biomedical Analysis, Vol. 208 (2021). An API fingerprint is a...

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Change in EDQM timelines for CEP applications

EDQM 26/11/2021 Strasbourg, France

On 1 October 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) commenced the use of a new IT tool to manage CEP applications. The implementation of this tool requires that timelines for evaluation of all CEP applications and their revisions/renewal be specified in...

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SAVE THE DATE! Conference celebrating the publication of the 11th Edition of the European Pharmacopoeia (19-21 September 2022)

EDQM 15/11/2021 Strasbourg, France

After almost two years of online events, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is eager to announce the organisation of an international conference to celebrate the publication of the 11th Edition of the European Pharmacopoeia (Ph. Eur.). This in-person event...

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EDQM Laboratory’s ISO 17025:2017 accreditation renewed

EDQM 15/11/2021 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) Laboratory successfully obtained the renewal of its accreditation according to the ISO/IEC 17025:2017 standard in October 2021 from the Belgian accreditation organisation BELAC, confirming the validity of the results...

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Shipments of orders in December: check EDQM order reception deadlines

EDQM 09/11/2021 Strasbourg, France

To check whether orders for publications or reference standards can be shipped in 2021, users are invited to consult the EDQM order reception deadlines for December. The dates by type of item are given in the following document: Order & shipment deadlines – December 2021. See also: Ph. Eur....

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PDG signs-off on milestone harmonised general chapter on chromatography

EDQM 08/11/2021 Strasbourg, France

The harmonised general chapter Chromatography was signed-off by the Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP), on 28 September 2021. The coordinating pharmacopoeia for...

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Joint presentation of EDQM and DH-BIO about Council of Europe principles of voluntary non remunerated blood donation / prohibition of financial gain with respect to donation at Members of the European Parliament hosted event

EDQM 05/11/2021 Strasbourg, France

Human plasma is the critical component of numerous therapeutic products used in the treatment of life-threatening diseases, including bleeding or immune system disorders and other severe pathologies. In recent years, the global use of and demand for plasma for fractionation have grown and it is a...

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5 new Ph. Eur. reference standards and 19 replacement batches released in October 2021

EDQM 04/11/2021 Strasbourg, France

New Ph. Eur. reference standards 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...

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CEP holders invited to comment on draft monographs published in Pharmeuropa 33.4

EDQM 20/10/2021 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 33.4. The table below lists the substances...

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Implementation of the European Pharmacopoeia Supplement 10.7 – Notification for CEP holders

EDQM 19/10/2021 Strasbourg, France

Supplement 10.7 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 2022, and to follow the...

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PDG prepares pilot for global expansion of membership

EDQM 18/10/2021 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 preparing a pilot to integrate additional world...

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European Pharmacopoeia device version to be discontinued

EDQM 15/10/2021 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) will discontinue the device version of the European Pharmacopoeia (Ph. Eur.) as of the 11th Edition, which is scheduled for publication in July 2022, and focus efforts on the online and paper versions. The EDQM was the...

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Revised osmolality chapter for public comment in Pharmeuropa

EDQM 14/10/2021 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter on Osmolality (2.2.35), published in this quarter’s issue of Pharmeuropa (33.4) for comment (deadline 31 December 2021). The revision work focused on the osmolality reference solutions using...

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Registrations open! Brand new Quality Risk Management training for blood establishments

EDQM 14/10/2021 Strasbourg, France

The supply of blood components involves a series of complex processes composed of numerous steps, each carrying intrinsic and extrinsic risks. Blood establishments must continuously adapt to new regulatory and technical requirements in quality management as part of their risk avoidance strategy....

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Application date closed - Recruitment in progress : Scientific Assistant – Hazard Classification

EDQM 13/10/2021 Strasbourg, France

Do you have experience in chemical hazard classification and/or Safety Data Sheet (SDS) requirements? Are you detail-oriented and able to work under pressure and meet deadlines? 

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European Day for Organ Donation and Transplantation, 9 October 2021: Join us online to celebrate! #JustSayYesEODD

EDQM 09/10/2021 Strasbourg, France

This year, celebrations for the European Day for Organ Donation and Transplantation (EODD) will take place online on Saturday, 9 October. EODD is an opportunity to discuss organ, tissue and cell donation and transplantation and reflect upon their importance, as well as to thank donors, their...

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4 new Ph. Eur. reference standards and 21 replacement batches released in September 2021

EDQM 08/10/2021 Strasbourg, France

New Ph. Eur. reference standards 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...

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Certification monthly report of activities: September 2021

EDQM 08/10/2021 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. September 2021 Certification Monthly Report For more information, access the Certification Database.

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New in European Paediatric Formulary: Phosphate oral solution monograph

EDQM 07/10/2021 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has added a new monograph, Phosphate 60 mg/mL Oral Solution, to the European Paediatric Formulary. Elaborated by a dedicated European Pharmacopoeia (Ph. Eur.) working party, the monograph was initially published in Issue 3...

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Draft monograph on Oxygen (98 per cent) published for comment in Pharmeuropa

EDQM 06/10/2021 Strasbourg, France

A new draft monograph, Oxygen (98 per cent) (3098), has been published for comment in this quarter’s issue of Pharmeuropa (33.4), the European Pharmacopoeia (Ph. Eur.) online forum. The deadline for comments on the new monograph is 31 December 2021. This draft monograph is the outcome of a...

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Pharmeuropa 33.4 just released

EDQM 05/10/2021 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 33.4 is 31 December 2021. Users and interested parties are welcome to comment on these drafts. It should...

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European Pharmacopoeia Supplement 10.7 now available

EDQM 04/10/2021 Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) Supplement 10.7 is now available and will be applicable in 39 European countries as of 1 April 2022. This volume is included in the 2022 subscription (10.6, 10.7 and 10.8) to the 10th Edition of the Ph. Eur. Subscriptions for print and/or electronic versions...

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Join us online to celebrate the European Day for Organ Donation and Transplantation on 9 October 2021! #JustSayYesEODD

EDQM 30/09/2021 Strasbourg, France

Organ, tissue and cell transplantation is one of the great medical success stories of modern times. In many cases, it is the only life-saving treatment for patients with end-stage organ failure, devastating burn injuries or blood cancers, and in many others it can significantly improve the...

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Risk of the presence of mutagenic azido impurities in losartan active substance

EDQM 29/09/2021 Strasbourg, France

In April 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) reported that it had received information about the possible presence of potentially mutagenic azido impurities in certain sartan active substances. Investigations requested by the EDQM indicated that only a...

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Certification of suitability: revised terms of reference and rules of procedure

EDQM 27/09/2021 Strasbourg, France

A revised version of the terms of reference and rules of procedure for the Certification of suitability to the monographs of the European Pharmacopoeia (CEP) procedure has been adopted by the Certification Steering Committee and is available on the website of the European Directorate for the...

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New EDQM IT tool for the management of CEP activities – Impact for CEP applicants and CEP holders

EDQM 24/09/2021 Strasbourg, France

From the beginning of October 2021, the CEP Department (DCEP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) will use a new IT application for the management of its activities. The implementation of this tool will entail certain changes in the way the EDQM...

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OMCL Annual Meeting 2021: European Quality Control Programmes and Strategies for Medicines

EDQM 22/09/2021 Strasbourg, France

The 26th Annual Meeting of the European Network of Official Medicines Control Laboratories (OMCLs) took place from 6 to 10 September 2021 and was held virtually due to the ongoing pandemic situation. The meeting, organised by the European Directorate for the Quality of Medicines & HealthCare...

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Newsletter Transplant 2021 now available

EDQM 21/09/2021 STRASBOURG, FRANCE

The 2021 edition of the Newsletter Transplant has just been published. It summarises comprehensive information and data for 2020 from 82 countries worldwide on donation and transplantation activities, management of waiting lists, organ donation refusals and authorised centres for transplantation...

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Certification monthly report of activities: August 2021

EDQM 14/09/2021 Strasbourg, France

The latest monthly activity report for the Certification of Substances Department (DCEP) is now available. August 2021 Certification Monthly Report For more information, access the Certification Database.

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2 new Ph. Eur. reference standards and 15 replacement batches released in August 2021

06/09/2021 Strasbourg, France

New Ph. Eur. reference standards 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...

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Publication of a new general chapter on balances in European Pharmacopoeia Supplement 10.6

EDQM 03/09/2021 Strasbourg, France

At its 168th session (November 2020), the European Pharmacopoeia (Ph. Eur.) Commission adopted a new general chapter: Balances for analytical purposes (2.1.7). This new chapter is included in Supplement 10.6 of the Ph. Eur., published in July 2021. This addition to section 2.1. Apparatus fills a...

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Revised guidance for electronic submissions for CEP applications

EDQM 01/09/2021 Strasbourg, France

As the eCTD format is mandatory for the submission of all applications for Certificates of suitability to the monographs of the European Pharmacopoeia (CEPs), except for applications for the risk of transmissible spongiform encephalopathy (TSE) (PDF format) and for substances for veterinary use...

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6 new reference standards and 16 replacement batches released in July 2021

EDQM 05/08/2021 Strasbourg, France

New Ph. Eur. reference standards 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...

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New publication on an EDQM Biological Standardisation Programme study for standardisation of allergen products

EDQM 03/08/2021 Strasbourg, France

Following the successful completion of the BSP090 study on recombinant major allergens, in collaboration with project leaders from the Paul-Ehrlich-Institut, an article on one of the major study outcomes “Validation of a candidate European Pharmacopoeia standard method for quantification of major...

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Preventing food contamination: new multi-analyte methods for the determination of substances migrating from printing inks to food or food simulants

EDQM 28/07/2021 Strasbourg, France

The quality and safety of materials and articles which come into contact with food need to be controlled. The European Directorate for the Quality of Medicines & HealthCare (EDQM) therefore develops guidelines for such items through the work of the European Committee for Food Contact Materials...

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Join the EDQM as Head of the Communications Section!

EDQM 22/07/2021 Strasbourg, France

Do you have professional media or communications experience, including drafting press releases, social media news and responding to journalist requests, gained in a medical/scientific setting?

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CEP holders invited to comment on draft monographs published in Pharmeuropa 33.3

EDQM 15/07/2021 Strasbourg, France

CEP holders are requested to consult the list of substances for which draft revised monographs of the European Pharmacopoeia (Ph. Eur.) have been published in Pharmeuropa 33.3. The table below lists the substances affected by these revisions and for which CEPs have been granted.

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Implementation of the European Pharmacopoeia Supplement 10.6 – Notification for CEP holders

EDQM 13/07/2021 Strasbourg, France

Supplement 10.6 of the European Pharmacopoeia (Ph. Eur) is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on 1 January 2022, and to follow the instructions given below. The table at the end of this announcement...

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New monograph on a single-source anti-TNF-alpha monoclonal antibody released for public consultation in Pharmeuropa

EDQM 12/07/2021 Strasbourg, France

A new draft monograph, Golimumab concentrated solution (3103), has been published in this quarter’s issue of Pharmeuropa (33.3), the European Pharmacopoeia (Ph. Eur.) online forum for comment. Following the adoption and publication of the monographs for Etanercept (2895) and Infliximab...

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