On 2nd April MEPs voted to adopt the new Clinical Trials Regulation by a huge majority of 547 in favor and 17 against. The Regulation means that as of mid-2016 any clinical trials undertaken in the EU will need to make their results public. More importantly for orphan drugs however, is the fact that the Regulation brings with it a streamlined application process, removing red tape surrounding clinical trials and therefore making cross border trials far simpler to undertake.
The result of the old directive becoming the new Clinical Trials Regulation, means that there can no longer be variations on how to conduct clinical trials across the EU, there will now be ‘one continent, one law’. The Clinical Trials Regulation will put in place a ‘one stop portal’ for all applications to conduct clinical trials, simplifying the approval process.
Orphan drug clinical trials are usually conducted across borders, due to their being low numbers of patients to participate in studies. With new regulation, the ability to conduct multinational trials is far simpler, with one application being submitted, compared with multiple applications under the old system. Alongside this, the time frame for agreeing to a trial has become far more competitive, countries now have 60 days to agree the trial, from putting the proposal into the portal, to countries completing risk assessments for ethics and science. There is 60 days to agree the whole clinical trial process and if countries don’t outwardly reject the trial, there is a legal precedent that the trial can go ahead. Therefore demonstrating the significant improvement that the Regulation provides for orphan drug clinical trials.
The Regulation provides a simplified system for all clinical trials being conducted in the EU and its positive impact on orphan drug development cannot be understated, it will facilitate cross border trials and reduce the red tape involved.
If you are interested in finding out more about either Clinical Trials or Orphan Drugs why not join us at the Fast Tracking Orphan Drugs Briefing on 10th July where you can learn about new early access programs and EMA licensing developments. Or join us on 9th September for our Clinical Trials Briefing, where we will be discussing the new Regulation detailed above and the impacts it will have on the pharmaceutical industry.