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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