An EU Regulation intended to encourage research into advanced therapies by micro, small and medium-size enterprises (SMEs) has been published in the Official Journal and is expected to enter force next week.

The Italian government said that its reorganisation of AIFA, the national medicines regulatory agency, is nearly complete as a new board of directors was installed yesterday.

Independent researchers and researchers investigating advanced therapies in Spain should find it easier to gain approval for clinical trials thanks to a new support office, says the health ministry.

It's been a busy week for the European Medicines Agency. Not only has it recommended marketing approval of the first advanced therapy product under the new regulatory framework, it has also finally decided that all drugs containing the opioid painkiller dextropropoxyphene should be withdrawn for safety reasons.