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November 2018

Coming Soon: New EU Clinical Trial Portal and Database

On June 16, 2014, the European Union published Regulation EU No. 536/2014, which intends to “…ensure a greater level of harmonization of the rules for conducting clinical trials throughout the EU.” Though it was endorsed by the EMA Management Board on December 14, 2014, the Regulation will become applicable six months after the European Commission publishes a confirmation notice, which is estimated to take place in 2019.

This Regulation has introduced several changes, including a new EU Clinical Trial Portal and Database which has been referred to as “the backbone of the new regime for clinical trials in Europe.” The EU Portal will provide a single-entry point for data submission, and the EU Database will house all submitted data.

The Regulation will also simplify safety reporting via a web-based form, increase transparency around clinical trials data by making information submitted through the EU Database publicly available (unless matters of confidentiality prohibit access), and easier-to-follow guidelines. The EU Portal and Database are expected to go live in 2020.

Also of interest are the rules around low-level interventions, the intention of which is to identify additional adverse reactions, clinical effects, and other new and important information. These trials are already covered by a marketing authorization and other evidence-based means, and therefore pose a low risk to patients.

These innovations in the European clinical trial space are intended to change the process of drug approval in the EU for the better. It is important to look to processes recently adopted by other countries as potential improvements in other nations, and to determine what additional review may be required to successfully shape this new legislation.

 

References:

Tenti, E., Simonetti, G., Bochicchio, M. T., & Martinelli, G. (2018). Main changes in European Clinical Trials Regulation (No 536/2014). Contemporary clinical trials communications11, 99-101. doi:10.1016/j.conctc.2018.05.014 https://ec.europa.eu/health/human-use/clinical-trials/regulation_en

Disclaimer: This article and the SCRS website are public resources of general material and do not constitute legal or professional advice.