Quality & use of medicines
The European Network of Official Medicines Control Laboratories
The OMCL Network brings together official laboratories from 35 European member states and seven non-European countries to protect public health by ensuring the quality and safety of medicines on the market. By preventing substandard and falsified medicinal products from reaching patients, the network plays a critical role in safeguarding public health, ensuring that treatments are effective and averting potential harm. The OMCL Network is committed to upholding these high standards through robust market surveillance studies and anti-falsification initiatives.
Co-ordinated by the EDQM and co-funded by the EU, the General European OMCL Network (GEON) thrives on collaboration. From facilitating swift communication and knowledge sharing to harmonising standards and testing methodologies and pooling resources, the GEON is instrumental in safeguarding public health and promoting trust in medicinal products. By working together, the laboratories enhance their collective capacity to respond quickly and efficiently to challenges, delivering results that have a positive impact on public health across Europe and beyond.
Quality management
Work programme
Mutual Joint Audits (MJAs)/Visits (MJVs) and Training Visits (TVs)
Harmonising QMSs among OMCLs and achieving appropriate quality levels remain the principal goals of this activity. This enables the mutual recognition of test results between members, in programmes such as official batch release testing of biologicals, market surveillance of authorised medicines and falsified medicines testing.
In 2024 the audit programme was conducted primarily as on-site assessments in laboratories, with one audit conducted remotely.
Nine full reassessment MJAs and one training visit were carried out in 2024. Since the launch of the QM programme for OMCLs in 1997, a total of 248 MJAs, 52 MJVs and 29 TVs/tutorials have been conducted.
Training courses/workshops
The EDQM organised two workshops: a workshop for auditors of the MJA/MJV system for sharing auditing experience in September 2024, and a workshop on Computerised Systems Validation in October 2024.
PTS studies
The EDQM Proficiency Testing Scheme (PTS) programme provides laboratories with an objective means of assessing and demonstrating the reliability of their data. In 2024, five studies each were organised in the physico-chemical and biological fields.
International co-operation
The External Quality Assurance Assessment Scheme (EQAAS) phase 11, organised in collaboration with WHO, was finalised in 2024.
The EDQM is a recognised stakeholder of the European Co-operation for Accreditation association (EA) and regularly attends EA/Laboratory Committee (EA/LC) meetings, with the objective to strengthen collaboration with EA/LC members, and clarify technical questions of interest to the OMCL Network related to the interpretation of ISO/IEC 17025:2017 requirements.
Publications, databases and website
Common QM guidelines supporting laboratories in the implementation of ISO/IEC 17025:2017 requirements are drafted by experts belonging to the network and are updated on a regular basis under the co-ordination of the EDQM Secretariat. In 2024, two guidelines were published; five other documents are currently under revision (see table “Quality Management Documents elaborated in 2024”).
GEON activities
New GEON member
The Analysis and Control Laboratories Department of the Turkish Medicines and Medical Devices Agency became a full GEON member in August 2024. Türkiye acceded to the Convention on the Elaboration of a European Pharmacopoeia in 1993 and has been a member of the EPC ever since. It formally requested GEON membership in 2022. The GEON looks forward to co-operating closely with the Turkish OMCL in the various network programmes and working groups. This is a tangible result of the EDQM’s strategic efforts to expand its international outreach to tackle global health issues more effectively.
Work programme
GEON Annual General Meeting
The GEON Annual General Meeting was held in person from 13 to 17 May 2024 in Ohrid, North Macedonia, bringing together about 230 participants from 38 member states on-site, attending nine different sessions. In light of the 30th anniversary of the OMCL Network, part of the meeting was dedicated to reflecting on the history of the network and to presenting and discussing challenges in the years to come.
A number of presentations covered different aspects of the GEON strategic goal of capacity building. Another part of the meeting focused on different QMS topics relevant for the network. For the first time the topic of green chemistry was discussed, and it was decided to elaborate a strategy for the network.
Watch the OMCL Network 30th anniversary session of the EDQM 60th anniversary conference below for a lively and informative discussion of how the OMCL Network ensures quality control of medicinal products through collaboration and mutual recognition of test results.
General market surveillance studies
The testing phase of the market surveillance on rosuvastatin API and tablets (MSS063), which was launched at the end of 2023, took place during 2024. The market surveillance study on medical face masks (MSS064) was finalised. A new study was launched on pregabalin hard capsules (MSS062).
Active Pharmaceutical Ingredients (API) Working Group
The re-orientation of the scope of the API WG activities and of future market surveillance fingerprint studies (MSSFP), initiated in 2023, was confirmed in 2024 by the review of the corresponding API WG position paper and the MSSFP procedure.
In 2024, the MSSFP006 study on lenalidomide was launched, with a focus on API quality surveillance, in line with the revised scope of the API WG.
OMCL Falsified Medicines Working Group
The report of the sixth market surveillance study on suspected illegal products (MSSIP) on “Selective androgen receptor modulators (SARMs), metabolic modulators and small-molecule growth hormone secretagogues used as performance enhancing substances” was issued in December 2024. The most frequently reported substances were ibutamoren, ostarine and cardarine.
The results from the seventh MSSIP study on “Nootropics” were collected by November 2024. The most frequently identified substances were levodopa, ephedrine/pseudoephedrine and modafinil and its analogues. The final report is expected to be delivered in 2025.
The eighth MSSIP study on “Antibiotics from illegal sources” was launched in February 2024.
The OMCL document “Aide-Memoire: Testing of Suspected Illegally Traded and Falsified Medicines” was revised mainly to introduce a new chapter for medical devices. A revised version of the “Aide-Memoire: How to identify a falsified monoclonal antibody/antibody containing fusion protein” was also released.
As part of the Suspicious Unknown Products (SUP) programme, a new study (SUP013) was organised in 2024, with the participation of 27 OMCLs, to identify the substance present in a blind sample.
OMCL Gene Therapy Products Working Group (GTWG)
The OMCL GTWG is currently composed of 11 OMCLs. The 14th meeting of the group was held virtually in September, during which OMCL capacity building in gene therapy products testing – to support centralised market surveillance – was discussed. This was also an important topic at the OMCL annual meeting. Progress was made in validating standard methods for quality control of adeno-associated virus (AAV) based vector products. This included the publication of results from a study entitled “Validation of an ELISA method for determination of physical particle titre of AAV2-based vector preparations” (details below) and two ongoing projects, one on infectious genome titres and the other on AAV2/8 physical particle titre by enzyme-linked immunosorbent assay (ELISA).
Nitrosamines – Sampling strategies and testing methods
Members of the GEON have been involved in various activities related to the detection of nitrosamines in APIs and medicinal products since mid-2018. A dedicated OMCL testing group has met 16 times since then and has extended its scope beyond the nitrosamine group (including nitrosamine drug substance-related impurities – NDSRIs) to the determination of mutagenic impurities at trace levels (e.g. azido impurities reported in tetrazole sartans).
Based on the lessons learned during the nitrosamine contamination incident, an addendum to the internal OMCL Network document “Incident management” was issued in December 2024. This addendum contains additional points to be considered in cases where limited resources and/or a limited number of OMCLs capable of performing the necessary testing would be available during a crisis.
A hands-on training session for OMCLs on nitrosamine testing was held in June 2024 by the Swissmedic OMCL in Bern. In the context of the Centrally Authorised Product (CAP) Sampling and Testing co-operation programme with the European Medicines Agency (EMA), a dedicated nitrosamine testing programme for centrally authorised products was set up and scheduled to run starting in January 2025.
More information on initiatives to prevent nitrosamine contamination is available on the EDQM’s dedicated nitrosamines web page.
International co-operation
The EDQM facilitated exchanges between the World Organisation for Animal Health (WOAH) and the OMCL Network for the establishment of collaboration projects in the fight against substandard and falsified medicines. In addition, discussions were held with WHO to find synergies between their “Global surveillance and monitoring system for substandard and falsified medical products” (GSMS) database (currently under development) and the EDQM’s Know-X database.
EDQM representatives were involved in different meetings and training sessions organised by WHO, the EMA and the African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD) with the support of different international partners in promoting capacity building of African OMCLs.
Publications, databases and website
In 2024, four new general OMCL Network documents were finalised, and five others were revised.
A publication by the GTWG entitled “Validation of an ELISA method for determination of physical particle titre of AAV2-based vector preparations” was published in Pharmeuropa Bio & Scientific Notes (see Bibliography).
CombiStats
CombiStats is a recognised reference tool for the statistical analysis of bioassay results which contributes to the mutual recognition of data and results by all interested parties. A new online version of the tool was released in October 2024 to replace the desktop version. CombiStats, accessible through an individual and secure connection (e-mail and password), now offers a modern user interface, dedicated workspaces, a large set of statistical models and other updates such as an audit trail. A more flexible licence management system was also introduced. As of early December 2024, nearly 800 licences for the online application had been sold. This statistical tool is used in more than 30 European countries and 30 others around the world.
EU/EEA-specific activities
Work programme
Market surveillance for products with a centralised marketing authorisation
The CAP regular programme covers an annual list of products drawn up by the EMA Secretariat together with the EMA Scientific Committees and with final input from the OMCL CAP Advisory Group. In 2024, 36 medicinal products for human use, seven for veterinary use and one API were scheduled for testing.
The 2024 CAP Generics programme included lenalidomide, meloxicam and zoledronic acid products.
In response to the increasing number of biosimilars in 2024, adalimumab was selected as the next project under the Biosimilar programme as a continuation of the first three projects covering the molecules filgrastim, etanercept and rituximab.
An additional CAP market surveillance programme focuses on authenticity checks on parallel-distributed products, and testing of seven products was concluded in 2024.
The results of the 2024 programmes showed that the vast majority of products tested were of the expected quality and complied with the authorised specifications. By 31 December 2024, no products with out-of-specification results had been found. However, regulatory, technical or editorial findings for a few products were reported to and followed up by the EMA.
Mutual Recognition Procedure/Decentralised Procedure post-marketing surveillance scheme
The 20th regular programme was carried out in 2024, covering roughly 1 100 product testing projects (completed). Testing reports for 2024 were issued by 27 different OMCLs; 16% of tested products were for veterinary use. Regulatory issues were identified in 3.4% of projects. In 3.5% of cases, one or more out-of-specification results were reported. The OMCLs involved in this activity met twice in 2024 (May and November) to evaluate the programme and discuss ways to optimise collaboration.
The HMA Post-Marketing Risk Assessment (PM RA) Tool working group continued discussions to find appropriate solutions for the collection of post-marketing risk signals from different stakeholders. In January 2024, new features were implemented in the MRP/DCP/API database hosted by the EDQM, allowing the collection of risk signals from OMCLs, based on the laboratory testing results of MRP/DCP products.
OCABR of biologicals for human use
The activities of the network for Official Control Authority Batch Release (OCABR) foster the mandatory mutual recognition of batch release for human vaccines and medicinal products derived from human blood and plasma. OMCLs perform a quality review of every batch through testing and protocol review.
The human OCABR annual meeting focused on blood products, vaccines and common issues, and provided an opportunity to exchange expertise, optimise resources and develop strategies to enhance the common approach.
The election for two OCABR Advisory Group posts took place in 2024. The final composition of the OCABR Advisory Group includes three representatives for the blood field (from the Netherlands, Spain and Germany) and three for the vaccine field (from Belgium, Austria and France).
In 2024 the OMCLs evaluated close to 12 600 final batches of vaccines for human use and human blood-derived medicinal products and screened about 14 000 plasma pools for safety. This activity provides independent confirmation that the quality of these products meets the established requirements before they reach patients. About 135 COVID-19 vaccine lots were released in 2024, in contrast to 2023 and 2022, when over 320 and 1 700 lots were released, respectively, reflecting the end of the COVID-19 global health emergency. Despite a decrease in the demand for COVID-19 vaccines, the total number of vaccine lots assessed increased compared to 2023. This reflects the introduction of new vaccines on the European market, such as two new vaccines for respiratory syncytial virus (RSV) and one for chikungunya virus, as well as a growing demand for travel vaccines like yellow fever, typhoid fever, Japanese encephalitis and tick-borne encephalitis (TBE) vaccines. The number of vaccines in the development pipeline is steadily increasing and OMCLs have reacted by preparing numerous new and revised guidelines and by implementing new methods in preparation for batch release.
Several examples where the collaboration between OMCLs and the presence of a backup OMCL were critical to the resilience and reliance of the batch release system were reported. In the blood field, this included co-operative efforts to evaluate and resolve technical issues noted during HIV-antibody testing in certain plasma pools. As demand for testing capacity increased, a new optimisation strategy for testing recombinant protein vaccines, initiated in 2023, contributed to better use of resources.
In 2024, OMCLs continued their commitment to the 3R principles (reduce, refine, replace) for animal testing in batch release. OMCLs continued the exercise of data collection and reporting on the use of animals for OCABR, which started in 2022. According to the data provided by OMCLs, a global decrease can be seen over the years 2019 to 2022. The network decided to continue the exercise in 2025. Discussion on the animal use reporting table triggered a revision of the OCABR guideline on mechanisms to reduce in vivo testing by OMCLs during OCABR.
Several OMCLs reported plans to implement in vitro methods for diphtheria (D), tetanus (T) and acellular pertussis (aP) antigenicity testing. The EDQM held a virtual meeting in July 2024 that allowed interested OMCLs to share information and set the stage for a potential future alignment of their strategies.
In view of the removal of the rabbit pyrogen test from the Ph. Eur., OMCLs have been preparing to implement the monocyte activation test (MAT) where relevant, as well as to revise the product-specific guidelines. Progress in the replacement of the limulus amoebocyte lysate (LAL) test with recombinant factor C test for bacterial endotoxins was also noted.
OMCLs are seeing an increase in their batch release activities, resulting in the participation of additional OMCLs who are newer to the activity. In addition, new marketing authorisation holders (MAH)/manufacturers are arriving on the scene. In response, a new general guideline to promote a common approach in the OMCL–MAH/manufacturer interactions was adopted in May. The guideline was well received, and it was proposed to prepare a version that could be shared with manufacturers.
Batch release of immunological veterinary medicinal products
The Veterinary Batch Release Network (VBRN) is an important forum for the confidential exchange of quality and technical information on immunological veterinary medicinal products (IVMPs) and related methods and is a key link in the regulatory chain. It fosters the mandatory mutual recognition of OCABR of IVMPs, and has enabled the adoption of a goodwill agreement to mutually recognise Official Batch Protocol Review (OBPR) certificates between member states provided the procedure and rules codified by the network are followed.
The network is overseen by an elected advisory group consisting of four representatives from different member states. The current composition includes representatives from Belgium, Germany, Poland and the Slovak Republic. A plenary meeting bringing together all the representatives is held annually. The VBRN Advisory Group met twice in 2024 to move forward on important issues and prepare for the annual meeting in May.
The Advisory Group developed a new guideline to support OMCLs and competent authorities (CAs) in the development of an electronic platform based on the experience of one OMCL and supplemented with feedback and experience from other network members. The use of common templates to better co-ordinate activities for post-marketing surveillance was continued, with six OMCLs contributing data in 2024, covering future plans and reporting on 2023. The annual meeting was an opportunity for the network to reflect on how OMCLs could make the best use of the information collected and the Advisory Group will propose a revision of the current strategy to this end.
The short-term testing strategy initiated in 2023 for a quality issue concerning an oral rabies vaccine (live) continued in 2024 and was extended to include another product from the same manufacturer with a similar manufacturing process. The OMCLs involved in the testing of these products successfully interacted with their CAs and the manufacturing process was investigated, resulting in amendments to the marketing authorisation (MA). The OMCLs involved are closely monitoring the issue and will report at the next annual meeting.
OMCLs involved in the batch release of IVMPs also supported 3R initiatives. An OMCL reported that they had successfully implemented an in vitro potency test for rabies vaccine (inactivated) for veterinary use. Other OMCLs expressed interest in exchanging standard operating procedures in order to build overlapping capacities and competencies regarding in vitro testing of these vaccines, as well as in investigating whether it would be possible to develop a common method.
The VBRN Advisory Group met representatives of IVMP manufacturers in March. The meeting was productive, allowing for open exchange and reminders of good practices, a review of lessons learned from the COVID-19 crisis, updates on new developments and a review of plans for the implementation of 3R strategies.
A successful training session on OBPR of IVMPs for newcomers, attended by 35 participants from 14 countries, was run virtually in October.
International co-operation
The Human OCABR Network continued co-operation in the global arena via its Memoranda of Understanding with authorities from Canada, the United Kingdom, Australia, Israel and the Taiwan Food and Drug Administration (TFDA). The EDQM and members of the EU OCABR Network also contributed to the activities of the WHO Network for National Control Laboratories for WHO prequalified biologicals.
The VBRN continued co-operation with the United Kingdom via a Memorandum of Understanding.
Publications, databases and website
By the end of 2024, the MRP/DCP Product Testing Database – set up in 2007 to improve co-operation on planning, sampling and reporting of testing activities carried out on MRP and DCP products within the OMCL Network – held more than 19 000 records, with contributions from 37 different OMCLs. Database access is restricted to OMCLs and health authorities.
Risk-assessment templates, which also include test recommendations for MRP and DCP products, have been regularly transferred to this database since March 2020. By the end of 2024, the database held about 3 300 templates.
Two new and seven revised batch release guidelines for vaccines for human use were published. In addition, the EU Administrative Procedure for OCABR was revised to add a new annex (annex IIh).
