New Clinical Trial Regulation Now Live

As of 31 January 2022, Regulation (EU) 536/2014 is now in force.  The new Regulation sets out new and harmonised requirements for clinical trials with a view to establishing the EU as major hub for clinical research.

Clinical trials are a vital part of the development of new and safe medicines and medical treatment.  Prior to 31 January 2022, the conduct of clinical trials was regulated under Directive 2001/20/EC.  The Clinical Trials Directive represented an important step towards the harmonisation of experimental research, but has seen recent criticism by stakeholders (ranging from patients to researchers and industry players).  This is largely due to the disproportionate regulatory requirements and high costs imposed under the Directive, which also required multiple submissions and authorisations to be filed at each Member State level. Under the old Directive, there was a decline in the competitiveness of the EU as a preferred location for clinical research.