EU Agencies Update

At the start of 2007, the European Union grew again to 27 member states, with the accession of Bulgaria and Romania boosting the EU's patient population to nearly 500 million. And European regulatory affairs have continued to become more complex.
In part this is a result of the rapid growth of the EU itself—with a total of 12 member states still trying to master the requirements they have had to take on board since they joined.
But it is equally a consequence of developments in technology and in health care. This year has been marked by uncomfortable reminders of the risks as well as the benefits of new medicines. Regulators have struggled to get a satisfactory grip on first-in-man trials in the wake of the disastrous Tegenero trial in 2006. There has been new emphasis on pharmacovigilance and on patient information. And clinical trial rules have come in for criticism for making medicines development more difficult while putting patients at greater risk.

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