Sampling and testing of centrally authorised products

The European Medicines Agency (EMEA) published recently a summary of results of the first 10 years' working of its programme of sampling and testing of products that have been authorised through the Centrally Authorised Products provisions f the European Medicines Directives.

The EMEA scheme, which is run as part of its responsibilities for the "co-ordination of the supervision, under practical conditions of use, of medicinal products authorised within the European Community", is carried out with the co-operation of the European Directorate for the Quality of Medicines (EDQM) and local competent authorities" national testing programmes. It complements these national surveillance schemes which focus mainly on nationally authorised products and/or products authorised through the mutual recognition procedure.

Under the EMEA scheme, testing results are classified as:

• complying with no identified problems
• regulatory issues identified
• out of specification results, or
• health risk

Currently about 40 products per year are tested and under the scheme so far there have been nearly 300 products tested representing a significant proportion of the products authorised through the centralised procedure. To date, no products tested have been reported as presenting a risk to health.

For the future, the EMEA does not see any major changes to the programme although there will be a move to a more risk-base approach to inclusion in the annual programme rather than automatic inclusion on the third anniversary of authorisation. EMEA envisages partially implementing this change in the 2009 programme. Also, the EMEA will be seeking to optimise the use of member states" official laboratory resources in the annual programmes.

The full report makes interesting reading and can be found on the EMEA website..