An SME takes the AAP: the story of Soliris
Alexion recently became the first pharmaceutical company to have an orphan drug (Soliris) authorised via the European Medicines Agency’s (EMEA’s) accelerated assessment procedure (AAP). Frédéric Bassi, the company’s European Product Manager, spoke to EURALex about the challenges the procedure poses and the simultaneous benefits of obtaining “SME status”. Soliris received orphan drug designation from the EMEA in October 2003. After that it was became the subject of phase III clinical trials in both Europe and the US.

CMD (v) clarifies procedure for changing Reference Member State
The Coordination Group for Mutual Recognition and Decentralised Procedures (veterinary) (CMD (v)) has clarified a procedure that marketing authorisation holders should apply in order to change the Reference Member State (RMS) for their products. The authority has pointed out that this procedure is not regulated in the present pharmaceutical legislation, however, it may be necessary to implement during the life-cycle of a veterinary product. As the CMD (v) noted, a marketing authorisation holder’s (MAH’s) request to change the RMS is only allowed in “exceptional circumstances”, for example when the marketing authorisation for a given drug is no longer valid in that Reference Member State.

UK pharmaceutical industry expresses anxiety over PPRS reform
UK minister for health Alan Johnson’s announcement about his intention to re-open negotiations with the drugs industry on the Pharmaceutical Price Regulation Scheme has been met with some concern by the pharmaceutical industry. The move, however, is in line with conclusions reached in report published by the Office of Fair Trading (OFT) - UK’s consumer and competition authority - in February of this year (see EURALex, Issue 180, p29) .