A majority of hospitals are involved in research studies which often take the form of clinical trials. In 2012 the European Commission published a proposal to revise the Clinical Trials Directive 2001/20/EC . The new legislative text, the Clinical Trials Regulation, was adopted in April 2014.
In 2010, HOPE contributed to this new legislation by releasing a paper answering the Commission public consultation on the assessment of the functioning of the “Clinical Trials Directive” 2001/20/EC and released a position paper. HOPE considers the Regulation to be a significant improvement to the previous Directive on Clinical Trials and a clear attempt to streamline the authorisation of new clinical trials.
On 28 May 2016, the Regulation was fully applicable.
On 24 March 2017, the Commission released its Implementing Regulation on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014.
The next evaluation of the impact of the Regulation on Clinical Trials on scientific and technological progress in Europe is planned for 2025.