EU publishes clinical trials regulation

A new regulation that will allow sponsors to submit a single application to conduct a clinical trial in Europe has been (see BioCentury Extra, April 2).

EMA said it has been working in parallel on a transparency policy to proactively release patient-level clinical trial data. The agency's board is to discuss implementation at a meeting next month. EMA said that policy will provide a "bridge" until the new legislation comes into force in 2016 (see BioCentury Extra, March 24). ...