The European Parliament voted on the text of the new Clinical Trials RegulationUndertaking Follow Up
European Clinical Trials Regulation
The Academy's 2011 report 'A new pathway for the regulation and governance of health research' highlighted the need for a full revision of the EU Clinical Trials Directive 2001/20/EC. The report emphasised the need to amend the Directive to ensure a more proportionate approach to the approval and monitoring of clinical trials of the safety or efficacy of medicines.
In July 2012 the European Commission published proposals for a new Regulation to replace the Clinical Trials Directive. The Academy has undertaken a number of activities to influence the development of the Regulation, including: convening stakeholder meetings; developing joint briefings and statements; and responding to consultations.
The European Parliament voted on the text of the new Clinical Trials Regulation April 2014. It is anticipated that the provisions of the new Regulation will become applicable in mid/end 2016.
We will continue to liaise with our partners to monitor the implementation of the Regulation, especially on issues such as the development of the EU portal and database and to ensure that the Regulation's vision of greater risk proportionality is adopted by regulators across all processes from authorisation to monitoring of trials and GCP inspections.
The Academy has recently developed the following briefings and statements with partner organisations:
- Joint statement from non-commercial and commercial organisations on the proposed European Clinical Trials Regulation [Nov 2012]
- Paper outlining the academic and charity sectors’ position on proposals for clinical study reports [May 2013]
- Academic and charitable sector position on the possibility of
ICH-GCP becoming a legal requirement in the Clinical Trials Regulation [Oct 2013]
In response to the Medicines and Healthcare products Regulatory Agency's 2012 consultation on the proposed new EU Clinical Trials Regualtion, the Academy submitted a letter and joint statment on the Regulation that was developed with partner organisations.
Following on from submissions to the European Commission's 2010 consultation on the impact of the European Clinical Trials Directive, the Academy has responded in the following ways to the 2011 concept paper on proposed changes:
- An Academy response.
- A response from the Federation of European Academies of Medicine (FEAM).
- A joint statement from non-commercial research organisations in the UK.
The Academy has responded to the European Commission's 2010 consultation on the impact of the European Clinical Trials Directive 2001/20/EC.
We have also contributed to a response from the Federation of European Academies of Medicine (FEAM) and a subsequent FEAM statement on this topic.