Centrally Authorised Products Testing (CAP)

Background: current regulatory context

Since 1995, the Commission of the European Communities has granted community marketing authorisations for new medicines. Products that receive this authorisation can ipso facto be marketed throughout the EU and the EEA. A co-ordinated approach to quality control in the various markets then becomes necessary and involves the EU / EEA Member States of the OMCL Network. The surveillance of products having received such a marketing authorisation is organised by the EMEA and the EDQM. Each yearly programme includes products that were granted a community marketing authorisation 3 years before. In case of a specific problem, additional products can be included.

Operational procedure

An operational procedure for sampling and testing of community authorised products has been developed, based on a collaboration between the EMEA, the EDQM and the national authorities. A contract was signed in June 1999 between the EMEA and the EDQM that will govern a yearly programme for the surveillance of the medicinal products. For these medicines, the network decided that sampling from three different countries on average would be sufficiently representative of the European Union market. Samples are collected in principle throughout the entire medicines distribution chain (wholesalers, community or hospital pharmacies) by national inspectors. Samples of each product are sent to the EDQM, which allocates them to two national control laboratories for testing in accordance with well-established protocols derived from marketing authorisation dossiers. The analysis and results are collected by the EDQM. A report is established and sent to the EMEA for any follow-up that might be needed.

Achievements in 2007

The programme for sampling and testing of Centrally Authorised Products (CAP) was successfully continued in 2007 and entered its 9th consecutive year. Since its implementation, the programme has been continuously improved thanks to the close collaboration of all stakeholders:

• the EMEA which is the sponsor and has the overall responsibility for the programme,
• the EDQM which coordinates sampling and testing operations on the basis of the information provided by the marketing authorisation (MA) holders upon request from the EMEA, and reports to EMEA the outcome of sampling and testing operations, especially the control results, with proposals for follow-up actions where necessary,
• the national inspection services of the designated Member States within the EEA which perform product sampling on the market,
• the OMCLs of the EU/EEA OMCL Network which perform analytical testing of products.

The CAP programme covers medicinal products for both human and veterinary use. In 2007, it included 40 products divided between 14 non-chemical products (biotech or veterinary immunological products) and 26 chemical/pharmaceutical products. In addition, testing was also carried out on the active substances of 3 of these products.

These figures correspond to an increase of 25% compared to the 2006 CAP programme. The different partners of the programme agreed that a fixed number of products would be included in each yearly programme. The target of at least 40 products was considered to be appropriate and this target number was met in 2007. This number also allows the inclusion of products on an ad hoc-basis should specific issues emerge. Products to be included in the 2007 programme were selected by the EMEA expert committees from those authorised in 2004 (year n-3), thus guaranteeing that the selected products have indeed been launched and manufactured on a large scale. In addition, some products tested in previous years were included for re-testing based on specific recommendations from concerned authorities.