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 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.
The programme for sampling and testing of Centrally Authorised Products (CAP) continued successfully in 2013 and entered its 15th 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 2013 work programme included 38 medicinal products for human use (12 biologicals and 26 chemical products) and 7 medicinal products for veterinary use (3 immunobiological products and 4 chemical products). Two ad-hoc tests were performed according to the recommendations of the Rapporteur. In addition to the finished dosage form, testing of active substances (API) was performed for 7 products. The total number of products (45) corresponds to the optimal range considering the operational capacities of the OMCL Network.
About 49 per cent of the products (i.e. 22 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. Repetition of testing was carried out in 2013 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 10R) was revised in 2013 in order to detail the current working processes.
A CAP standard procedure for handling future CAP Generics programmes was drafted in 2012 based on the experiences acquired with the 2011 Clopidogrel generics trial programme. The document “General Procedure for Sampling and Testing of Generic Centrally-Authorised Products” (PA/PH/CAP (12) 32 9R) was fine-tuned in 2013 and was released after adoption by the OMCL Network in December 2013.
In December 2013, the co-ordination activities of the EDQM with respect to the CAP Sampling and Testing Programme successfully underwent an ISO9001 re-audit conducted by AFNOR.
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