Development Safety Update Reports

The Development Safety Update Report (DSUR), also known as the ctIMP Annual Safety Report is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study) among the International Conference on Harmonisation (ICH) regions.

US and EU regulators consider that the DSUR, submitted annually, would meet national and regional requirements currently met by the US Investigational New Drug Annual Report and the EU Annual Safety Report, respectively, and will therefore take the place of existing safety reports.

The main objective of a DSUR is to present a comprehensive annual review and evaluation of pertinent safety information collected during the reporting period related to a drug under investigation, whether or not it is marketed, by:

• Examining whether the information obtained by the sponsor during the reporting period is in accord with previous knowledge of the investigational drug’s safety.
• Describing new safety issues that could have an impact on the protection of clinical trial subjects.
• Summarising the current understanding and management of identified and potential risks.
• Providing an update on the status of the clinical investigation/development programme and study results.

For international trials, reference on DSUR production and submission will be detailed in contractual agreements and/or specific protocol documents.

It is the responsibility of the sponsor to send our DSUR reports annually for every ctIMP study to the MHRA and to the main REC.