Changes are being made to the clinical trials regime, intended to simplify the clinical trials procedure by introducing a single set of procedures across the EU. The new system will not take effect until May 2016 at the earliest, but will include:
- A single set of rules, including tight timetables for member states and sponsors;
- A single web-based application portal;
- Division of trials into higher and lower risk categories;
- A new database to store and make clinical trial information publicly available;
- Rules allowing co-sponsorship to take account of collaborative agreements, for example between a drug company and an academic institution;
- Rules specifying that trials in non-EU countries can only be used to support an EU application for marketing authorisation if they have met EU requirements.