EDQM’s ISO 9001:2015 certification maintained

EDQM 08/02/2024 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 28 and 29 November 2023 by the official French standardisation body Association française de...

Read More

Save the date: EDQM conference celebrating 60 years of excellence in public health protection

EDQM 18/01/2024 Strasbourg, France

In 2024, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is celebrating 60 years of excellence in the protection and promotion of public health. We are delighted to announce the organisation of a conference to mark this occasion, on 11 and 12 June 2024, in Strasbourg...

Read More

OMCL confirms falsification of Ozempic® batches

EDQM 05/12/2023 Strasbourg, France

Following concerns that falsified batches of Ozempic® may have entered the market, the Official Medicines Control Laboratory (OMCL) Chemisches und Veterinäruntersuchungsamt (CVUA, Karlsruhe, Germany) and a member of the European OMCL Network, has determined by analytical testing that suspected...

Read More

Next-generation sequencing for adventitious virus detection in biologics: EDQM collaborates on article published in Biologicals

EDQM 08/11/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has co-authored a report with a broad range of academics and interested parties, entitled “Report of the third conference on next-generation sequencing for adventitious virus detection in biologics for humans and animals”....

Read More

Journal of Pharmaceutical Sciences publishes results of the OMCL fingerprint study on tadalafil API samples

EDQM 03/11/2023 Strasbourg, France

The Active Pharmaceutical Ingredient (API) Working Group of the General European OMCL Network (GEON) has conducted a market surveillance study on tadalafil, the results of which have been published in the Journal of Pharmaceutical Sciences, Vol. 112 (2023). An API fingerprint is a specific...

Read More

OMCL Gene Therapy Working Group study published

EDQM 26/10/2023 Strasbourg, France

The outcome of a study run in the framework of the European Network of Official Medicines Control Laboratories (OMCLs) Gene Therapy Working Group (GTWG) has been published online in Pharmeuropa Bio & Scientific Notes. The article, entitled “Validation of a qPCR method for determination of viral...

Read More

Validating analytical procedures for determining nitrosamines in pharmaceuticals: European OMCLs participate in collaborative study with international regulatory agencies

EDQM 08/09/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) and representatives of official medicines control laboratories (OMCLs) in Europe, as well as the US Food and Drug Administration, Health Canada and the Therapeutic Goods Administration, Australia, have co-authored an...

Read More

28th GEON annual meeting: another successful OMCL event

EDQM 19/06/2023 Strasbourg, France

The 28th annual meeting of the General European OMCL Network (GEON) was held in Madrid (Spain) from 5 to 9 June 2023 and brought together about 350 participants – on-site and online – from all over Europe and beyond. The four key strategic goals of the Network, which are pivotal for the future...

Read More

Ph. Eur. Commission keeps pace with veterinary vaccine development efforts

EDQM 02/06/2023 Strasbourg, France

The first DNA vaccine granted a marketing authorisation in the European Union (EU) dates back to 2016 and is intended to protect Atlantic salmon against salmon pancreas disease (SPD) caused by salmon alphavirus subtype 3. Veterinary vaccine manufacturers have been developing third generation...

Read More

Independent control of COVID-19 vaccines: article co-authored by the EDQM and members of the OCABR Network published in npj Vaccines

EDQM 27/02/2023 Strasbourg, France

The European Directorate for the Quality of Medicines & HealthCare (EDQM) and members* of the Official Control Authority Batch Release (OCABR) Network of the General European OMCL Network (GEON) have co-authored an article entitled “Independent Control of COVID-19 Vaccines by EU Official Control...

Read More

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...

Read More

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...

Read More

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...

Read More

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...

Read More

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

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...

Read More

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....

Read More

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...

Read More

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...

Read More

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)...

Read More

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...

Read More