While the Clinical Trials Regulation (EU No. 536/2014) (the Regulation) was adopted in April 2014, the Regulation does not come into operation until 6 months after the clinical trials portal and database (the EUPD) has been set up, independently audited, and notification of the successful audit published by the Commission. The operation of this database has been delayed a number of times, as the development of a system to cover so many aspects of the new Regulation is taking longer than expected.
The EUPD aims to increase the efficiency of clinical trials conducted in the EU by creating a single entry point for the submission of clinical trial applications and ethics committee approvals, as well as adverse event reporting, and a database of key documents for, and the results of, clinical trials. Further, many of the documents submitted will be publicly available under the new transparency rules.
In a recent meeting, the EMA Management Board heard that the development of the auditable version of the EUPD is nearing completion and that its development has entered an “intensive phase of testing”. Where needed, development resources are being adjusted to ensure quality and progress are in line with the project plan. The EMA Board also agreed refinements to the governance, reporting and user engagement process to support the project through the final phases of development. Currently, its anticipated release is November 2018. Provided this goes to plan, the independent audit will start in early 2019, and so the Regulation will be applicable towards the end of next year. Despite being treated as a priority, the EMA Management Board has warned that some further planning adjustments may be required to account for the EMA’s relocation to Amsterdam.
In the meantime, other aspects of the introduction of the Regulation are continuing. In April 2018, the Commission published Draft Questions and Answers on the Regulation. This document is under preparation by the Commission, but has been submitted for discussion to the Commission’s expert group on clinical trials. It goes some way to explaining the scope of the EUPD (and other aspects of the Regulation), in particular, where the results of sub-studies will need to be submitted, and the dates by which clinical trial sponsors must notify their relevant Member State of key events (such as the start of the clinical trial and the first patient/first visit). Some questions are still blank, as the Commission and key stakeholders continue to discuss the interpretation and operation of the Regulation.
The Commission has indicated that this document will be updated from time to time, as is the case with the current version of the Questions and Answers under the Clinical Trials Directive 2001/20/EC.