These activities involve the EU/EEA OMCL Network only.

Background

Since 1995, the Commission of the European Union has being granting community marketing authorisations for new medicines for both human and veterinary use. These are known as centrally authorised products (CAP). Such products can be marketed in all EU/EEA member states, so a co-ordinated approach to controlling the quality of these products is necessary. In June 1999, a contract governing an annual CAP Sampling & Testing Programme was signed by the European Medicines Agency (EMA) and the EDQM. The EMA is the sponsor of the programme and has overall responsibility for it, whereas the EDQM co-ordinates the sampling and testing operations. The EDQM’s duties include reporting the results of the testing programme and proposing follow-up actions, if necessary, to the EMA. National inspection services gather sample products from the market and members of the EU/EEA OMCL Network test them.

Since 2009, each annual programme has included products selected using a risk-based approach. Previously, a systematic approach had been used, i.e. each yearly programme included products that had been granted a community market authorisation 3 years previously.

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The Procedure

The list of products to be included in the annual programme is prepared by the EMA Secretariat in collaboration with the EMA Scientific Committees. This is sent to the EDQM, which then co-ordinates the sampling and testing operations on the basis of the information provided by the marketing authorisation holders (MAH) at the request of the EMA. Samples are collected, in principle, from throughout the entire medicines distribution chain (i.e. from wholesalers and community and hospital pharmacies) by nominated national sampling contacts. Samples are collected, on average, from three different countries. These are sent to the EDQM, which allocates them to national control laboratories for testing in accordance with well-established protocols derived from marketing authorisation (MA) dossiers. The EDQM collects the analyses and results and produces a report, which includes the quality control results and proposals for follow-up action, if necessary. This report is sent to the EMA.

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Benefits of the CAP Sampling & Testing Programme

A position paper: The advantages and benefits of the CAP Surveillance Project, was released in November 2013. This document underlines the value of this multi-disciplinary activity and also includes a statistical evaluation of the programme as well as a chapter discussing future considerations.

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Achievements in 2023

The concerted Centrally Authorised Products (CAP) Sampling & Testing programme has entered its 25th consecutive year. Since its initiation, the programme – originally covering ‘regular’ medicinal products for human and veterinary use and generics – has been continuously improved thanks to the close collaboration between its partners. Two new programmes were added to the CAP in 2019.

A list of products to be included in the annual Regular programme is jointly prepared by the EMA Secretariat and the EMA Scientific Committees, with input from the OMCL Network and the EDQM, applying a risk-based approach. For the Generics programme, three testing campaigns are conducted every year. 

The 2023 CAP Regular programme included 38 medicinal products for human use (17 biologicals, including two insulin-based products, and 21 chemical products) and six medicinal products for veterinary use (three immunobiological products and three chemical products). Additional active pharmaceutical ingredient (API) testing was performed for one product.

The 2023 CAP Generics surveillance programme covered products containing desloratadine, ibandronic acid and pemetrexed.

In response to the increasing number of biosimilars, a five-year (2019-2023) Biosimilar programme, comprising three projects on CAP products containing filgrastim, etanercept and rituximab. While the Filgrastim project was finalised in 2022, the Etanercept and Rituximab projects were completed in 2023.

At the same time, the Parallel distributed products testing programme was set up to verify the authenticity of the products selected. Three products were tested under this programme in 2023.

The results of the 2023 programmes showed that the vast majority of products tested were of the expected quality and complied with the authorised specifications. As of 31 December 2023, only one product with out-of-specification results had been found. In addition, regulatory or technical findings for a few products had been reported to and followed up by the EMA.

The EDQM’s co-ordination activities with respect to the CAP Programme are certified by AFNOR Certification and audited on a regular basis.