These activities involve the EU/EEA OMCL Network only.
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 yearly programme includes products selected through a risk-based approach. Previously, a systematic approach was used, i.e. each yearly programme included products that had been granted a community market authorisation 3 years previously.
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) upon a request from 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.
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.
Achievements in 2016
The programme for sampling and testing of Centrally Authorised Products (CAP) continued successfully in 2016 and entered its 18th consecutive year. Since its initiation, the programme has been continuously improved thanks to the close collaboration among its partners.
In 2007, the programme partners agreed that a fixed number of products (i.e. 40) would be included in each annual programme. This target number allows for the inclusion of products on an ad-hoc basis should specific issues emerge.
30 medicinal products for human use (10 biologicals and 20 chemical products) and 7 medicinal products for veterinary use (3 immunobiological products and 4 chemical products) were tested as part of the 2016 work programme. In addition to the finished dosage form, testing of active substances (APIs) was performed for 3 products.
Furthermore two generics surveillance programmes on Repaglinide and Leflunomide-based products were run in 2016.
About half of the products (i.e. 20 products) had already been tested during a previous programme. The re-testing of products demonstrates the commitment of the EMA, the EDQM and the OMCLs to ensure that the quality of products is controlled several times during their life-cycle. Repeated testing is mainly carried out because of major changes in the manufacturing process of the product(s) since their initial testing or because of a high number of Marketing Authorisation variations related to quality.
End of 2016, ISO 9001-compliance of the EDQM’s coordination activities with respect to the CAP Sampling and Testing Programme was re-certified by AFNOR Certification.
In 2014, it was decided to run a pilot project on biosimilars to check the possibility to test biological products on the same model as chemicals products within the Generics programmes. Within this framework, a feasibility study on Filgrastim-based products was organised in 2016 and successfully finalised.