Centrally Authorised Products (CAP) Sampling & Testing Programme

These activities involve the EU/EEA OMCL Network only.

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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). 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.

Currently, 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 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, 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.

Achievements in 2012

The programme for sampling and testing of Centrally Authorised Products (CAP) continued successfully in 2012 and entered its 14th 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.

The 2012 work programme included 33 medicinal products for human use (11 biologicals and 22 chemical products) and 8 medicinal products for veterinary use (4 immunobiological products and 4 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 on two products. The total number of products tested in 2012 (41) corresponds to the optimal range considering the operational capacities of the OMCL Network.

About 44 per cent of the products (i.e. 18 products) had already been tested during a previous programme. The re-testing 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 2012 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.

The "General Procedure for Sampling and Testing of Centrally Authorised Products" (PA/PH/CAP (05) 49 9R) was revised in 2012 due to the implementation of new forms and streamlining of working processes.

A CAP standard procedure for handling future CAP Generics programmes had been drafted based on the experience acquired with the 2011 Clopidogrel generics trial programme. The “General Procedure for Sampling and Testing of Generic Centrally-Authorised Products” (PA/PH/CAP (12)32 6R) is an adaptation of the current CAP sampling & testing procedure. It was released after adoption by the OMCL Network in December 2012.

In December 2010, the co-ordination activities of the EDQM with respect to the CAP Sampling and Testing Programme successfully underwent ISO9001 certification. Follow-up audits were successfully passed in December 2011 and 2012.