Five years ago — in May 2014 — the European Parliament and Commission decided on a new Clinical Trial Regulation (EU No. 536/2014) to replace the existing Clinical Trials Directive 2001/20/EC. Since then, a complete legislative period has gone by but the regulation still has not been implemented.
The main point that prevents the implementation of the regulation is the setup of the data portal that is foreseen to allow for a one-time submission across the European Union. This portal is still under construction and the leading agency, the European Medicines Agency, encountered many difficulties in the design and setup of the portal. This is the main reason we are still waiting for the go-live date. The move of the EMA from London to Amsterdam as a result of Brexit was also another reason implementation has been delayed.
According to the EMA website, the implementation will now take place in 2020. (Realistically, this will occur in the fourth quarter 2020; thus, it would have taken more than six years to implement.) In the meantime, a discussion has started about whether it would make sense to update the regulation first and then implement an updated regulation. This implies that the original regulation as decided in May 2014 will never come into force in its original form.
When it is implemented, the regulation will have a major impact on the timelines for clinical trial study startup, especially when you compare the regulation’s timelines with those in EU member states. Under the new regulation, startup timelines will be harmonized across all EU countries. This leaves the pharmaceutical industry with an average startup timeline of close to 100 days for competent authority review followed by ethics review, as compared to 35 days in Belgium (known to be a fast startup country) under the current system.
Companies have to consider changes in timelines as the EMA gets closer to implementing the new regulation. It will certainly have an effect on milestones like first-patient-first-visit. For this reason, sponsors planning a study start in 2020 may prefer to be under the old system during the transition time and, therefore, should submit clinical trial applications earlier in 2020, if at all possible. Additionally, the new system may bring further uncertainties regarding timelines and approvals. Therefore, sponsors may prefer to stick to what they know so they can avoid as many unknowns as they can.
In the end, when implementation comes, I expect it will come quickly and with little warning, leaving us as an industry with a short transition period. So be prepared.