Newsroom OMCL
Collaborative study on validation of an ELISA method for determination of physical particle titre of AAV2 vectors: outcome published
The Gene Therapy Working Group (GTWG) of the General European Official Medicines Control Laboratory (OMCL) Network (GEON) organises collaborative studies to validate analytical methods for the quality control of gene therapy products. A recent study focused on the validation of an ELISA method...
OMCL Network welcomes Türkiye as a full member
The Analysis and Control Laboratories Department of the Turkish Medicines and Medical Devices Agency has become a full member of the General European OMCL Network (GEON), co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM). It is the first Turkish official...
Publication of outcome of study for Human Immunoglobulin (molecular size) BRP replacement batches
The outcome of the recently completed Biological Standardisation Programme study for the establishment of Human immunoglobulin (molecular size) Biological Reference Preparation (BRP) replacement batches 4, 5 and 6, has been published in the online journal Pharmeuropa Bio & Scientific Notes. The...
Making a significant difference – 2023 EDQM annual report published in new engaging digital format
The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe has published its 2023 annual report. For the first time, the report is completely digital, with a new, intuitive design and interactive features, facilitating your discovery journey and making it...
Improved CombiStats online application now available
The CombiStats online application is available as of 4 July 2024, with an improved interface, a new licensing system and a dedicated user workspace. Users are invited to start using the online application, by creating an account and following the registration steps. The contact person who placed...
30th anniversary of the OMCL Network – Celebrating the success of international collaboration for safe medicines at the 29th GEON meeting
The 29th Annual Meeting of the General European Official Medicines Control Laboratories Network (GEON) was held from 13 to 17 May 2024 in Ohrid (North Macedonia). Over 230 participants representing 63 official medicines control laboratories (OMCLs) from 38 countries attended this meeting, which...
First OMCL analytical procedures for determination of nitrosamine drug substance-related impurities (NDSRIs) and intermediate-related contaminants published
The official medicines control laboratories (OMCLs) of the General European OMCL Network (GEON) began developing procedures for the determination of N-nitrosamine contaminants in 2018. The resulting procedures have been published for information on the website of the European Directorate for the...
EDQM’s ISO 9001:2015 certification maintained
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...
OMCL confirms falsification of Ozempic® batches
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...
Next-generation sequencing for adventitious virus detection in biologics: EDQM collaborates on article published in Biologicals
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”....
Journal of Pharmaceutical Sciences publishes results of the OMCL fingerprint study on tadalafil API samples
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...
OMCL Gene Therapy Working Group study published
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...
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...