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 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.
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.
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.
The concerted CAP sampling and testing activities have entered their 21st consecutive year. Since its initiation, the programme has been continuously improved thanks to the close collaboration between its partners.
In 2019, three new programmes were added to the well-established CAP Regular and Generics programmes. The Regular programme remains unchanged: a list of products to be included in the annual programme is prepared by the EMA Secretariat, together with the EMA Scientific Committees, with input from the OMCL Network and with the EDQM applying a risk-based approach. However, changes were made to the CAP Generics test programmes in order to increase the yearly turnover of tested products; as of 2019, three generics programmes are conducted each year.
The 2019 CAP Regular programme included 37 medicinal products for human use (16 biologicals, including 2 insulin-based products, and 21 chemical products) and 8 medicinal products for veterinary use (4 immunobiological products and 4 chemical products). In addition to the finished dosage form, testing of the active pharmaceutical ingredient (API) was performed for 4 products. As part of the 2019 CAP Generics surveillance programme, products containing Capecitabine, Duloxetine and Sildenafil were tested.
Due to the increasing number of biosimilars, a Biosimilar programme was created. Three projects will be conducted over a period of five years (2019-2024) on CAP products containing Filgrastim, Etanercept and Rituximab.
A dedicated programme for the testing of Parallel distributed products was also introduced; currently, tests are limited to authenticity checks.
Because a high percentage of APIs used for the manufacture of medicines for the European market are produced outside of the EU/EEA, an ad-hoc CAP API programme has finally become part of the current co-operation agreement between the EDQM and the EMA. This new programme allows sampling and testing of a maximum of three APIs per year in connection with suspected GMP issues.
The results of the 2019 programmes showed that the vast majority of products tested were of the expected quality and complied with the authorised specifications. By 31 December 2019, one “confirmed out-of-specification” result and several regulatory and technical findings had been reported to and followed up by the EMA.
Towards the end of 2019, ISO 9001-compliance of the co-ordination activities of the EDQM with respect to the CAP Sampling and Testing Programme was re-certified by AFNOR.
Status January 2020