Industry Experience With New EU Procedures

The European Union's centralized drug approval procedure appears, 20months after introduction, to be functioning as a transparent and efficient review process, but the mutual recognition procedure has yet to achieve the same level of satisfaction, say the results of an ongoing international industry survey of the procedures conducted by the Centre for Medicines Research International.

The Centre examined the experience of 17 companies with 24 applications up to August 1996. Under the mutual recognition procedure, 14 applications already authorized in the Reference Member State have revealed a number of procedural difficulties, it says. When it comes to choosing the RMS, only four candidates (France, Germany, the Netherlands and the UK) out of the 15 have been favored. Since the speed of review varies considerably between countries, competency and efficiency are possible deciding factors.

The RMS produces an assessment report for mutual recognition - the time taken varies from 30 to 320 days, with a mean of 62 days. Concerned Member States then confirm receipt of a valid application, which takes on average 1-15 days. Although not wide, this discrepancy is still an important factor in determining the timing of a mutual recognition application, notes the report.