The Medicines and Healthcare products Agency (MHRA) is consulting on the European Commission’s proposal for a Clinical Trials Regulation. The Government is committed to ensuring that the European Union (EU) regulatory framework for clinical trials does not create unnecessary burdens on researchers and makes the EU an attractive place to conduct clinical trials. We are interested to hear the views from interested parties on the Commission’s proposal.


The proposal and the Commission’s impact assessment are available at: Revision of the Clinical trials Directive (external link)


The European Commission proposes to simplify the rules for the conduct of clinical trials and harmonise the way trials are conducted in the European Union. The proposed Regulation will replace the Clinical Trials Directive 2001/20/EC which has been the subject of significant concern amongst commercial and academic researchers since its introduction in 2004. It is widely acknowledged that the Directive reduced the attractiveness of the EU for conducting clinical trials on medicines. The Directive brought in unnecessary administrative and regulatory burdens, lacked clarity in some aspects and some Member States introduced additional requirements when implementing the Directive which limited harmonisation, created delays and increased costs for researchers.


The number of clinical trials conducted in the European Union fell by 25 percent between 2007 and 2011. In the UK, the number of commercial trials fell by 22 percent over the same period. Although this decline cannot be attributed solely to the Directive, it did have an effect on the cost and feasibility of conducting clinical trials. The Government made the revision of the Directive a priority in the 2011 Plan for Growth. The Government believes that the Commission’s proposal has the potential to create a more favourable environment for the conduct of clinical trials in the European Union.


The proposed legal text takes the form of a Regulation which replaces the existing Directive 2001/20/EC. One of the Government’s objectives for the new legislation has been to reduce the scope for different interpretation and implementation between Member States to improve efficiency and reduce costs and burdens for industry and for academic researchers while at the same time protecting trial subjects and safeguarding public health. As Regulations are directly binding in all Member States, the change of legal form should dramatically reduce the scope for Member States to introduce additional national requirements. Moreover, an effective mechanism for the assessment of multi-state trials will only be successful if all Member States work according to the same rules. The Government believes that a Regulation is therefore an appropriate instrument for harmonising the conduct of clinical trials in the Union.


The Commission’s Impact Assessment estimates that the proposal will lead to the following burden reduction:

  • A reduction of administrative costs by 270 million Euros across the EU as a consequence of streamlining the authorisation procedure;
  • A reduction of compliance costs by 440 million Euros across the EU as a consequence of streamlining the authorisation procedure;
  • A saving of 34 million across the EU as a consequence of removing the requirements for insurance and reducing the requirements for safety reporting for low interventional trials.  

We are keen to hear the views of interested parties on the European Commission’s proposal. Responses can be be filled in online, sent by email ( or by post to Sandor Beukers, 5th Floor, 151 Buckingham Palace Road, London, SW1W 9SZ by 31 December 2012.


Responses to the consultation will be published on the MHRA’s website (unless individual respondents ask us not to publish their response).


In addition to the consultation document, you will find below a link to the online response sheet and a consultation response sheet that can be used to send you response electronically or by post.


Posted on the UK MHRA website on 6 November 2012