A long-awaited regulation introduces major changes in the way that clinical trials are conducted across the EU, including a single application portal and new trial transparency requirements.

Days before the EU Clinical Trial Regulation is set to come into effect, a new initiative has been launched to track and support its successful implementation and help deliver other trial-related reforms. 

The European Medicines Agency is expecting a lively pipeline of advanced therapy medicines over the next few years. It is also making final preparations for the introduction of the new EU clinical trials system from the end of January next year.