The ten accession candidate countries expected to join the European Union in May 2004 - Cyprus, Czeck Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, The Slovak Republic and Slovenia - began work with the European Agency for the Evaluation of Medicinal Products (EMEA) on 1 April 2003 in a new phase of cooperation and will join scientific committees and working parties as observers. This builds on successful PERF (Pan-European Regulatory Forum) (1) preparatory training and exchange programmes.

As part of the ongoing preparations for accession, the EMEA has put in place a programme of benchmarking visits to national authorities of the accession countries, including Bulgaria and Romania. The visits are intended to enhance the implementation of an integrated quality management system to ensure good regulatory practices in the EU and provide targeted audit training for participating quality professionals (2).

References

1. http://perf.eudra.org

2. Document EMEA/D/8004/03, 31 March 2003, http://europa.eu.int