Posted by Michael Wonder on 06 Jul 2021
MHRA releases guidance in collaboration with Health Canada to improve patient safety in clinical trials through improving the quality of Development Safety Update Reports
6 July 2021 - The Medicines and Healthcare products Regulatory Agency and Health Canada have published guidance to improve the safety of patients in clinical trials through improved quality of the periodic safety reports known as Development Safety Update Reports.
The guidance applies to both marketed and non-marketed medicines that are undergoing clinical trials.
