The Medicines and Healthcare Products Agency (MHRA) is having consultations with the pharma industry and clinical research organisations (CROs) about the European Commission’s proposal to have a new clinical trials regulation. The MHRA is committed to ensure that the proposed  regulatory framework does not create unnecessary burden on researchers but would only ensure making Europe Union (EU) attractive and competitive for  human studies.  Global and Indian pharma companies/CROs would need to provide their views by December 31, 2012.

Two companies from Karnataka namely Biocon and CRO Ecron Acunova are present in the EU. The former’s Oral Insulin IN105 underwent clinical trials in the EU and the latter has its European headquarters in Frankfurt, Germany.  

The EC is keen to have one submission for both single-state and multi state trials replacing the current practice of separate submissions to the National Competent Authority and the Ethics Committees.

The proposed Regulation will replace the Clinical Trials Directive 2001/20/EC which was a concern amongst commercial and academic researchers since its introduction in 2004. The Directive reduced the attractiveness of the EU for clinical trials because it brought administrative and regulatory hassles, lacked clarity, created delays and increased costs for researchers. This led fall in the number of clinical trials conducted in the EU by 25 per cent between 2007 and 2011. Similarly in the UK too, clinical  trials fell by 22 per cent over the same period. Therefore, the Government made the revision a priority in the 2011 Plan for Growth. It felt the Commission’s proposal created a more favourable environment for clinical trials in the EU, reported MHRA.

The Commission’s Impact Assessment estimates that the proposal will reduce administrative costs by 270 million Euros across the EU as a consequence of  streamlining the authorisation procedure. It would also bring down the  compliance costs by Euros 440 million and generate savings to the tune of Euros  34 million removing the requirements for insurance and reducing the requirements for safety reporting for low interventional trials.

“It is heartening to note the objectives of change. The EU is demonstrating that a regulator has to balance the interest of several stakeholders in the life science research ecosystem. While regulators and NGOs in some countries are primarily focused on participant safety and public health, MHRA publicly accepted that changes in regulation it effected in early 2000 slowed down the number of clinical trials in their geography by 25 per cent. In order to promote academic and pharmaceutical research towards better health care, MHRA is willing to remove hurdles and ambiguities which increases time and cost to take new medicines to clinic. This will make Europe regain its competitive edge in clinical research, said DA Prasanna, chairman and founder, Ecron Acunova.

The proposed changes to the EU’s Clinical trial regulations are timely and in the right direction. The scope of changes and the central theme: ‘Risk-adapted regulation’ would allow judicious use of regulators’ limited resources and time. It would encourage many Indian generic drugs and biosimilar product companies to conduct clinical trials in EU by reducing time, complexity and cost and allowing affordable and safe products to be made available to patients quickly. This is in line with other regulatory agencies like the US FDA, which has also proposed risk based monitoring but is lot more comprehensive. India also could look at adapting some of the important aspects of these proposed changes to simplify, streamline the regulatory process for drug development, stated Nageswara Rao, general manager, Clinigene International, a subsidiary of Biocon.