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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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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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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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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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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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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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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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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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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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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Clostridium septicum vaccine antigen assays: new article available online in Pharmeuropa Bio & Scientific Notes

EDQM 29/06/2021 Strasbourg, France

The outcome of Part 2 of the BSP130 collaborative study run under the common aegis of the European Partnership for Alternative Approaches to Animal Testing (EPAA) and the European Directorate for the Quality of Medicines & HealthCare (EDQM) Biological Standardisation Programme (BSP) has just been...

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The Council of Europe appoints future EDQM Director

EDQM 28/06/2021 Strasbourg, France

The Council of Europe has appointed Petra Dörr, PhD, as future Director of the European Directorate for the Quality of Medicines & HealthCare (EDQM). She will take over the function from the current Director, Susanne Keitel, in October 2021. Petra Dörr comes to the EDQM with more than 25 years of...

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New Pharmeuropa Bio & Scientific Notes article: Factor VIII BRP

EDQM 11/06/2021 Strasbourg, France

An article on the successful outcome of a recent study of the Biological Standardisation Programme (BSP) of the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been published in Pharmeuropa Bio & Scientific Notes, the EDQM’s free online journal. The study for the...

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New OCABR guidelines on COVID-19 recombinant spike protein vaccines and non-replicating adenovirus-vectored COVID-19 vaccines

EDQM 23/04/2021 Strasbourg, France

The new Official Control Authority Batch Release (OCABR) Guideline for Pandemic COVID-19 Vaccine (Recombinant Spike Protein), 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 20 April 2021. The...

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

EDQM 07/04/2021 Strasbourg, France

The Guideline for Pandemic COVID-19 vaccine (mRNA) has been updated to include a model protocol for the submission of manufacturers’ data. This key guideline has been in force since 12 November 2020 with the list of tests to be carried out by an Official Medicines Control Laboratory (OMCL) for...

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New status of NIBSC (UK) as observer within OCABR network post-Brexit

EDQM 19/01/2021 Strasbourg, France

The Official Control Authority Batch Release (OCABR) Network for human vaccines and medicinal products derived from human blood and plasma and the National Institute of Biological Standards and Control (NIBSC, United Kingdom) have signed a memorandum of understanding (MOU) to renew, post-Brexit,...

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EDQM’s ISO 9001:2015 certification maintained

EDQM 13/01/2021 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare’s (EDQM) ISO 9001:2015 certificate has been maintained following the second surveillance audit of its quality management system on 7 and 8 December 2020 by the official French standardisation body Association française de...

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Brexit: End of mutual recognition of Official Control Authority Batch Release between the EU/EEA and the UK

EDQM 08/01/2021 Strasbourg, France

The United Kingdom left the EU on 31 January 2020 and the transition period for Brexit, during which EU legislation still applied, is over as of 31 December 2020. A trade deal for relations after 31 December 2020 has been negotiated between the EU and the UK, but the deal does not include mutual...

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Annual OMCL Network meeting focuses on role of OMCLs during the COVID-19 pandemic

EDQM 28/05/2020 Strasbourg, France

The annual meeting of the European Network of Official Medicines Control Laboratories (OMCLs) took place from 12 to 15 May 2020, online and with a reduced programme due to the COVID-19 crisis. It was attended by more than 350 participants from 39 countries and was organised by the EDQM. The...

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