The UK Government has announced vide press release dated July 06, 2021 that the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada have jointly published new guidance to improve the safety of patients in clinical trials through improved quality of the periodic safety reports known as Development Safety Update Reports (DSURs). The guidance shall be applicable to both marketed and non-marketed medicines that are undergoing clinical trials.
The DSURs review the safety of medicinal products used in clinical trials and are produced every year. At present, even though trial sponsors will have conducted assessments regarding safety concerns, these detailed safety assessments are not always included in the DSUR. This makes it difficult for some regulators to find out if all safety concerns have been thoroughly investigated and whether appropriate measures have been taken to mitigate the risks associated with the use of the investigational medicinal products during a trial.
The guidance builds on relevant existing international standards, including the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidance E2F, the Council for International Organizations of Medical Sciences (CIOMS) Working Group VII as well as each country’s relevant clinical trial legislation. It will further will improve transparency and ask sponsors to explain in the region-specific information section how they assessed the data included in the DSUR.
*Tanvi Singh, Editorial Assistant has put this story together.
