The European Commission published on Thursday 23 July a new version of its frequently asked questions on the implementation of Regulation 536/2014 on clinical trials. This document clarifies and completes a previous version, although the regulation will probably not be applied before 2021.
Further delays predicted
The Clinical Trials Regulation establishes a procedure for the examination of draft clinical trials of medicines common to all EU Member States, with a two-part evaluation: part I devoted to scientific evaluation and part II to ethical evaluation.
It entered into force 6 years ago and was supposed to come into force 6 months after the launch of a European portal centralising all information relating to clinical trial projects for medicines (Article 80 of the Regulation).
However, this step keeps being postponed because the portal is still not functional. According to a Commission official, these delays are due to technical problems. The official adds, without giving further details on the timetable, that an “independent evaluation of the system will start in December 2020”.
Additions to the questions/answers
Despite these delays, the Commission’s Directorate-General for Public Health has updated its questions and answers on the 2014 regulation. In particular, it has added new answers on the problems of missing documents in an application (2.10) and on the situations in which serious adverse reactions can be qualified as unexpected because of their specificities, severity or frequency (7.11). See the document: https://bit.ly/32Yq06V (Original version in French by Sophie Petitjean)