EU States "Must Own Mutual Recognition"

Two years' experience with the European Union's new centralized systemof medicines registration has been highly successful, but for the mutual recognition procedure the situation is different, the fourth Conference of Medicines Agencies, held last week in The Hague, The Netherlands, heard.

Koen Wiedhaup, group director, pharma, at Akzo Nobel, said mutual recognition's obvious advantages over the former multi-state procedure include very few cases of arbitration; where they occur, the Committee for Proprietary Medicinal Products' opinion is binding. But on the other hand, he said, the procedure seems to lack "ownership," and he called for more transparency and communication at an earlier stage between all involved parties.

Dr Wiedhaup noted the recent US study showing a median time for review of a group of 15 drugs by the US Food and Drug Administration of 5.8 months, while for the European Medicines Evaluation Agency and the European Commission it was 12.2 months. Two factors play a crucial role in the reasons for this, he said. First, in Europe there is no single source of legislation covering the total process, which leads to unclearly defined steps and deadlines. Second, the EU system allows more time than the FDA to complete the individual steps. The deadline for a CPMP opinion is 210 days after validation of the dossier and the maximum time allowed for a Commission decision is 90 days, yet in roughly 50% of approvals the total time has exceeded 300 days.