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Centrally Authorised Products (CAP) Sampling & Testing Programme

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). Ipso facto, they can be marketed in all EU / EEA Member States. A co-ordinated approach to controlling the quality of these products then becomes 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, and has overall responsibility for, the programme. Whereas, the EDQM coordinates the sampling and testing operations. This includes reporting the results 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.


Before, each yearly programme included products that had been granted a community market authorisation 3 years previously. In recent years, this systematic approach has been replaced by a risk-based approach (RBA).

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 who then coordinates the sampling and testing operations on the basis of the information provided by the marketing authorisation holders (MAH) upon request from the EMA. Samples are collected, in principle throughout the entire medicines distribution chain (i.e. from wholesalers and community and hospital pharmacies) by nominated national sampling contacts. Samples are collected from three different countries on average. These are sent to the EDQM, who allocates them to national control laboratories for testing in accordance with well-established protocols derived from marketing authorisation (MA) dossiers. The EDQM collects the analysis and results and establishes a report, which includes the quality control results and proposals for follow-up action if necessary; this is sent to the EMA.

Achievements in 2009

The CAP Sampling & Testing Programme was successfully continued in 2009. It entered its 11th consecutive year. Since its initiation, the programme has been continuously improved thanks to close collaboration among its partners.


In 2007, the programme partner's agreed that a fixed number of products would be included in each annual programme. 40 products was considered to be an appropriate target; this number allows for the inclusion of products on an ad hoc-basis should specific issues emerge.

 

In 2009, the programme comprised a total of 42 medicinal products, corresponding to 34 medicinal products for human use (14 biologicals and 20 chemical/pharmaceutical/radiopharmaceutical) and 8 medicinal products for veterinary use (1 immunobiological and 7 chemical). Testing on the active pharmaceutical ingredients (APIs) of 5 different products was carried out. Compared to 2008, there was an increase of 3% on the total number of products included in the programme.

 

The RBA was phased in with the support of 6 volunteering OMCLs, who ranked potential "candidate products". As of 2010, the RBA completely replaces the former "n-3" rule for selecting the CAP to be included in the annual programme.

 

8 products which had already been in one of the previous year's programmes were included in the current list. They were selected on the basis of proposals from OMCLs. The retesting of products demonstrates the commitment of the EMA, the EDQM and OMCLs to ensure that products are checked several times during their life-cycle and not only once every three years after the granting of the MA.

 

The main reasons leading to repeat testing in 2009 were either because of major changes in the manufacturing process of the product(s) since their initial testing or because of the high number of MA variations in the quality field. As of 2010, decisions on repeat testing will be taken on a risk ranking basis according to the RBA.

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