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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 In recent years, this systematic approach has been replaced by a risk-based approach (RBA).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 2011

The programme for sampling and testing of Centrally Authorised Products (CAP) was successfully continued in 2011 and entered its 13th consecutive year. Since its initiation, the programme has been continuously improved thanks to close collaboration among its partners.

In 2007, the programme partners 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.

The "General Procedure for Sampling and Testing of Centrally Authorised Products" PA/PH/CAP (05) 49, was revised in 2010 due to the implementation of new forms and streamlining of working processes. The updated version was released in December 2010 and is available on the EDQM website.

The 2011 work programme included 37 regular medicinal products for human use (16 biologicals and 13 chemical products) and 8 medicinal products for veterinary use (5 immunobiological products and 3 chemical products). One ad-hoc testing was performed according to the recommendations from the Rapporteur. In addition to the finished dosage form, testing of active substances [API] was performed for 9 products. The 2011 CAP programme included for the first time a group of CAP Generics and was dealt with by adapting the current CAP sampling & testing procedure to this new situation. A CAP standard procedure for handling future CAP Generics programmes will be drafted based on the experiences acquired during this trial programme. The first CAP generic product to be tested was Clopidogrel, 75 mg, film-coated tablets (6 products). The total number of products (43) tested corresponds to the optimal range considering the operational capacities of the OMCL Network.

About half of the regular products (i.e. 15 products) had already been tested during a previous programme. 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.

Repeat testing was carried out in 2011 mainly because of major changes in the manufacturing process of the product(s) since their initial testing or because of a high number of MA variations related to quality.

In December 2010 the coordination activities of EDQM with respect to the CAP sampling and testing programme had successfully undergone ISO9001 certification. A follow up audit was successfully passed in December 2011.