Quality & use of medicines
The European Network of Official Medicines Control Laboratories
The OMCL Network brings together official laboratories based in 34 European member states and in seven non-European countries. Together, they ensure the quality of medicines on the market and prevent substandard and falsified medicinal products from reaching their final users. This safeguards patients’ health by ensuring the efficacy of their treatment and averting potential harm.
The EDQM co-ordinates the activities and the work programme of the General European OMCL Network (GEON), which is co-funded by the EU. The network members once again demonstrated their flexibility and resilience in reorganising and redeploying resources in 2023 to overcome a wide range of logistical, economic and political difficulties.
Quality management
Work programme
Mutual Joint Audits (MJAs)/Visits (MJVs) and Training Visits (TVs)
Harmonising quality management systems among OMCLs and achieving appropriate quality levels remain the principal goals of this programme. This enables the mutual recognition of test results between members, such as official batch-release testing of biologicals, market surveillance of authorised medicines and falsified medicines testing.
In 2023 the audit programme was able to conduct on-site assessments in laboratories once again, with some remote assessments taking place whenever necessary.
Fifteen full reassessment MJAs, one surveillance MJA and one TV were carried out in 2023. Since the launch of the quality management programme for OMCLs in 1997, a total of 239 MJAs, 52 MJVs and 28 TVs/tutorials have been conducted.
Training courses/workshops
The EDQM organised a two-day hands-on workshop entitled “Evaluation and Reporting of Results” to help partners working in OMCLs understand and implement the requirements of the ISO/IEC 17025:2017 standard.
PTS studies
The EDQM Proficiency Testing Scheme (PTS) provides laboratories with an objective means of assessing and demonstrating the reliability of their data. In 2023, five studies each were organised in the physico-chemical and biological fields.
International co-operation
The EDQM is a recognised stakeholder of the European Co-operation for Accreditation association (EA) and regularly attends the EA/Laboratory Committee (EA/LC) meetings in order 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 quality management (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 2023, seven guidelines or recommendation documents were published; a further two documents are under revision (see table QM Documents elaborated in 2023).
GEON activities
Work programme
GEON Annual General Meeting
The GEON Annual General Meeting was held in-person from 5 to 9 June 2023 in Madrid, bringing together over 260 participants on-site, attending nine different sessions. The four strategic goals of the network, addressed through specific examples, were once again a common thread throughout the meeting week.
Specific topics addressed included the application of capillary electrophoresis techniques in OMCLs for different analytical purposes, and collaboration, with examples of training support and information exchange upon the initiative of individual network members. During the General Session, new GEON Advisory Group members and a new group chairperson were elected.
General market surveillance studies
Two market surveillance studies (MSS) were completed in 2023: “Olanzapine API and tablets” (MSS060) and “Breaking of glass ampoules” (MSS061). A new MSS on Rosuvastatin API and tablets (MSS063) was launched.
Active Pharmaceutical Ingredients (API) Working Group
The conclusions of the MSSFP005 study on clustering Tadalafil API samples were published in the Journal of Pharmaceutical Sciences (Deconinck et al. 2023). Discussions in the network on the re-orientation of the scope of future fingerprint studies have been initiated.
OMCL Falsified Medicines Working Group
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 Sport Performance Enhancers” was finalised. More than 300 results were collected from 14 OMCLs. A wide variety of substances was identified by the OMCLs, the most frequently reported being ibutamoren, ostarine and cardarine.
The seventh MSSIP on “Nootropics” was launched. It was decided that a new MSSIP on antibiotics from illegal sources would be launched in 2024.
As part of the Suspicious Unknown Products (SUP) programme, a new study (SUP012) was organised in 2023, with the participation of 29 OMCLs, to identify the substance present in a “blind” sample.
OMCL Gene Therapy Products Working Group (GTWG)
Currently composed of 11 OMCLs, the GTWG’s 13th meeting was hosted by the Danish Medicines Agency in Copenhagen. The outcome of the study “Validation of a qPCR method for determination of viral genome titres of AAV2-based vector preparations” was published in Pharmeuropa Bio and Scientific Notes (Ridoux et al. 2023). The GTWG finalised the white paper on the challenges of Gene Therapy Medicinal Products (GTMP) testing in the GEON. Progress was also made in validating standard methods for quality control of adeno-associated virus (AAV) based vector products.
International co-operation
The OMCL Falsified Medicines Working Group continued its collaboration with the Customs Laboratories European Network (CLEN), with each body inviting the other to participate in MSSs or in conferences and symposia they organised.
EDQM representatives were involved in different meetings and training organised by WHO and the African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD), with the support of different international partners, to promote capacity building of African OMCLs.
Publications, databases and website
In 2023, two new general OMCL Network documents were finalised, and two others were revised.
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. In 2023, its widespread use was stable, with 960 CombiStats licences issued. This tool is used in 34 European countries and 34 others around the world.
EU/EEA-specific activities
Work programme
Market surveillance for products with a centralised marketing authorisation
The Centrally Authorised Product (CAP) regular programme covers an annual list of products drawn up by the European Medicines Agency (EMA) Secretariat together with the EMA Scientific Committees, and with final input from the OMCL CAP Advisory Group. In 2023, 38 medicinal products for human use, six for veterinary use and one API were scheduled for testing.
The 2023 CAP Generics programme included desloratadine, ibandronic acid and pemetrexed products.
The CAP Biosimilar programme projects on etanercept and rituximab were finalised.
An additional CAP market surveillance programme focuses on authenticity checks on parallel-distributed products, and testing of three products was concluded in 2023.
The results showed that the vast majority of the products tested were of the expected quality and complied with authorised specifications. By 31 December 2023, only one out-of-specification result was found, and a few regulatory or technical findings were reported to and followed up by the EMA.
Mutual Recognition Procedure/Decentralised Procedure post-marketing surveillance scheme
The 19th regular programme was carried out in 2023, covering roughly 1 300 product testing projects (completed). Testing reports for 2023 were issued by 28 different OMCLs and 15% of the tested products were for veterinary use. Regulatory issues were identified in 0.5% of projects. In 3.4% of cases, one or more out-of-specification results were reported. The OMCLs involved in this activity met twice in 2023 (June and November) to evaluate the programme and discuss ways of optimising collaboration.
In October 2023, the Heads of Medicines Agencies (HMA) Post-Marketing Risk-Assessment (PM RA) Tool working group organised a training session for quality assessors in collaboration with the Estonian State Agency of Medicines and the EU Network Training Centre (EU NTC); participants from 24 countries took part. The aim of the session was to clarify the purpose of the current pre-authorisation RA/TR (Test Recommendation) tool and its connection with the post-marketing surveillance programmes. In addition, the future post-marketing RA tool was introduced.
OCABR of biologicals for human use
The activities of the network 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 biologicals Official Control Authority Batch Release (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.
Priority activities in 2023 included maintaining regular batch release to ensure a steady supply of essential medicines – such as childhood vaccines and human clotting factors – to the public and preparing for new products coming to the market. OMCLs evaluated around 11 900 final batches of vaccines for human use and human blood-derived medicinal products, and screened about 12 460 plasma pools for safety. About 320 lots of COVID-19 vaccines were released in 2023, in contrast to the previous year, when over 1 700 lots were released, reflecting a welcome end to the pandemic period and the global public health crisis. A collaborative article, published in February in npj Vaccines by EDQM staff and members of the OCABR Network, on the contributions of the network to the control of COVID-19 vaccines during the pandemic described highlights of the challenges, successes and lessons learned for the future (Milne et al. 2023). The number of vaccines in the development pipeline is steadily increasing and OMCLs have reacted by preparing numerous new and revised guidelines and implementing new methods in preparation for batch release. This activity provides independent confirmation that the quality of these products meets the established requirements before they reach patients.
In line with the commitment to reduce, refine and replace the use of animals for quality testing (the 3R principles) in the context of batch release, the OMCLs presented several completed initiatives, including the implementation of in vitro tests for tick-borne encephalitis vaccines, examples using recombinant factor C (rFC) for endotoxin testing, and the move to multiplex serology formats for diphtheria (D), tetanus (T) and acellular pertussis (aP) potency testing. These techniques can significantly reduce the number of animals used. Ongoing work to move to a completely in vitro approach for D, T and aP are being followed closely by the network with a view to future implementation.
A successful training session on OCABR of human biologicals for newcomers was run as a hybrid event in November. Participants included OMCLs, NCAs and manufacturers from the EU and worldwide, with 44 participants on-site and 156 attending online.
Batch release of immunological veterinary medicinal products
The Veterinary Batch Release Network (VBRN) Advisory Group met twice in 2023 to move forward on important issues and prepare for the annual meeting in June. This was an election year for the Advisory Group and the new composition includes representatives from Belgium, Germany, Poland and the Slovak Republic.
The use of common templates to better co-ordinate activities for post-marketing surveillance was continued, with six OMCLs contributing data in 2023 covering future plans and reporting on 2022.
In addition to the normal programme, which includes Official Batch Protocol Review (OBPR) and OCABR for products on the restricted list, the network remained vigilant and co-ordinated a short-term testing strategy for a specific quality issue for a particular product which was reported at the annual meeting.
OMCLs involved in batch release of immunological veterinary medicinal products (IVMPs) also supported the 3R initiatives by implementing in vitro potency tests for rabies vaccine (inactivated) for veterinary use at several involved OMCLs.
The Advisory Group finalised the update of guidelines and network documents to be in line with the implementation of the new EU Veterinary Medicinal Products Regulation (2019/6) which became applicable on 28 January 2022.
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 also contributed its experience in networking to the benchmarking workshop on the role of networks in vaccine lot release organised at the Egyptian Drug Authority in Cairo in November. 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.
Publications, databases and website
By the end of 2023, the Mutual Recognition Procedure/Decentralised Procedure (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 17 800 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 2023, the database held about 2 200 templates.
One new and 13 revised batch-release guidelines for vaccines for human use and one revised guideline for human blood and plasma-derived medicinal products came into force.
