EMEA "Will Not Be European FDA:" Sauer

It is neither desirable nor achievable for the European Union to have a totally centralized drug approval system, employing 3,000 staff in-house for this purpose as is the case with the US Food and Drug Administration, according to Fernand Sauer, the executive director of the European Medicines Evaluation Agency.

At the Agency's inauguration in London's Docklands on January 26, Mr Sauer said that the national competent authorities will remain the pillar of the EMEA, which is based on the centers of excellence existing around Europe. A European list of about 1,600 experts has been established, to serve within the multidisciplinary and multinational teams coordinated by the EMEA scientific committees. The national authorities will continue to perform their duties, but from now on will act on behalf of the EU.

Mr Sauer also said that the EMEA's timeframe for drug registrations will be much tighter than that of the FDA, with products being approved within 300 days as opposed to the FDA's average of four years. Strachan Heppell, chairman of the EMEA Management Board, added that the EMEA would aim to match the standards of the FDA and, if possible, do better.