Clinical Trials: all change 2019

For the last 18 years, clinical trials in the EU have been governed by the Clinical Trails Directive. The directive itself was seen at the time as a major milestone in ensuring more transparent and structured regulations relating to clinical trials. However, as time has moved and the landscape regarding clinical trials has changed, an updated set of regulations was needed. In 2014, the EU drafted the Clinical Trails Regulation. This regulation will replace the current directive from 2019. The regulation is intended to bring a much more harmonised approach and deliver major improvements including:

• consistent rules for conducting clinical trials throughout the EU
• publicly available information on the authorisation, conduct and results of each clinical trial carried out in the EU
• a streamlined application procedure for all clinical trials conducted in Europe via a single EU portal and database. All applicants must be registered before assessment.
• a single authorisation procedure for all clinical trials, to allow a faster and more thorough assessment by all concerned EU countries
• the extension of the silent agreement principle to the authorisation process, giving more legal certainty to sponsors and researchers, in particular SMEs and academics
• strengthened transparency for clinical trials data

Naturally there have been some bumps along the road and, initially, the transition was slated for 2015. However, more time was required to set up the IT infrastructure of the portal and so 2019 is the new target timeline.

Much work has been going on to update all the various supporting guidelines found in Eudralex 10, and companies are encouraged to familiarise themselves with these as they are continually being updated, with new additions made. There is an accepted 3-year transition period for all trials conducted and initiated whilst the Directive is still in force. The new regulation also contains important updates to relevant GCP and GMP directives and sponsors, manufacturers and all relevant parties should ensure alignment to the new set of regulations.

Although the exact date of implementation has yet to be made clear by the EMA, what is clear is that it is closer to completion than previously understood, and the agency should have an audited version of the portal for final evaluation by early 2019. Once the regulation goes live it is expected that the transition period will require good planning and strategy by companies, and sound regulatory acumen and intelligence to adequately prepare, plan and execute all clinical strategies and programs. ELC Group is proud to be at the forefront of helping its clients prepare for the future through our strategic partnerships and wealth of experience and expertise. We look forward to helping more potential clients prepare for this exciting new phase in clinical trials management.