Newsroom OMCL
Validating analytical procedures for determining nitrosamines in pharmaceuticals: European OMCLs participate in collaborative study with international regulatory agencies
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...
28th GEON annual meeting: another successful OMCL event
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...
Ph. Eur. Commission keeps pace with veterinary vaccine development efforts
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...
Independent control of COVID-19 vaccines: article co-authored by the EDQM and members of the OCABR Network published in npj Vaccines
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...
Full OCABR guideline for Pandemic COVID-19 vaccine, Inactivated, now available
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...
The EDQM participated in a conference on Next Generation Sequencing
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...
Revised OCABR Guideline for Pandemic COVID-19 vaccine (mRNA) now available
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...
OMCL Annual Meeting 2022: European Strategies for Work Sharing and Collaboration in Testing of Medicines
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...
OMCL Annual Meeting 2022: European Strategies for Work Sharing and Collaboration in Testing of Medicines
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...
EDQM ISO 9001:2015 certification renewed
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....
OMCLs participate in international regulatory collaboration on the analysis of nitrosamines in metformin‑containing medicines
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...
New OCABR guideline on inactivated COVID-19 vaccines
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...
Full OCABR Guideline for Pandemic COVID-19 vaccine (Recombinant Spike Protein) now available
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...
OMCL fingerprint studies on omeprazole and sildenafil API samples published in scientific journals – Update
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)...
Veterinary batch release network welcomes VMD, UK, as an observer
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...
BSP study outcomes published in Pharmeuropa Bio & Scientific Notes
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....
Journal of Pharmaceutical and Biomedical Analysis publishes results of the OMCL fingerprint study on omeprazole API samples
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...
OMCL Annual Meeting 2021: European Quality Control Programmes and Strategies for Medicines
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...
Clostridium septicum vaccine antigen assays: new article available online in Pharmeuropa Bio & Scientific Notes
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...
The Council of Europe appoints future EDQM Director
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...