Upcoming sponsor survey on CTR implementation

The follow-up sponsor survey on the CTR implementation is foreseen to be launched in September 2023.

Lead by the European Commission’s Directorate-General for Health and Food Safety (DG SANTE), an EU survey was conducted between 18 July and 9 September 2022. The survey collected the views of sponsor associations and sponsors that had submitted a clinical trial application under the CTR, with the aim of identifying critical hurdles perceived or experienced when submitting a clinical trial application under the CTR. A report summarising the responses to the survey and the processes implemented by the EMA, the Member States and the European Commission to provide solutions to the problems raised can be found here.

As part of ACT EU, a follow-up survey will be conducted in September 2023 to continue monitoring the implementation of the CTR and CTIS use and to inform improvements in the work of the European Medicines Regulatory Network on clinical trials. The second round of the survey aims to identify any remaining obstacles in the smooth implementation of the CTR and to measure progress achieved since the last survey. Further information, including the link to the survey, will be included in the September issue of this Newsletter.