Working Group XVI – Development Safety Update Report

Background

In countries that adhere to the 2010 principles of the International Conference (now Council) on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), the Development Safety Update Report (DSUR) is considered the standard report for informing regulators of the evolving safety profile of drugs under development. The content and format of a DSUR are discussed in ‘Development Safety Update Reports (DSUR): Harmonizing the Format and Content for Periodic Safety Report during Clinical Trials’ (CIOMS Working Group VII, 2006) and further described in the ICH E2F Guideline.
Post-marketing update reports have evolved from focusing only on the safety of an approved medicinal product1 [Periodic Safety Update Report (PSUR)] to providing an assessment of both the risks and benefits of the drug [Periodic Benefit-Risk Evaluation Report (PBRER), see ICH E2C(R2) Guideline]. Similarly, DSURs should evolve from reports that focus only on safety to provide a more comprehensive and transparent picture of available information of both the risks and benefits of a medicinal product under development. During the clinical development phase, signal detection can occur in a variety of ways and should lead to prompt communication of new safety issues through updates to the investigator’s brochure and, where appropriate, through urgent risk mitigation measures. The assessment of cumulative safety data in the DSUR should be used to inform risk assessment and management.
Currently, DSURs include listings of serious adverse reactions observed during the reporting period, cumulative summary tabulations of serious adverse events, evaluations of the risks, summary of important risks, and benefit-risks considerations. However, they lack a structured and clear description of how sponsors identified the risks, what signals were assessed during the reporting period, and how efficacy data contributed to the conclusion drawn regarding the benefit-risk evaluation.

CIOMS full concept note on Development Safety Update Report.

Working Group objectives

1. to recommend improvements to the content and format of the DSUR in accordance with expanding safety activities and evolving regulatory requirements.
2.  to review how the DSUR can be updated to better communicate information about the safety and benefit-risk balance of the investigational drug to the regulatory authorities.

Progress

• 1st meeting held on 25-26 February 2025 (Geneva)

CIOMS Working Groups usually take around 3 years to finalize their consensus document and recommendations. Most groups hold one or two in-person meetings per year, with virtual meetings in between. The groups make use of collaborative efforts and capitalize on existing initiatives in order to provide output that is as comprehensive as possible, does not duplicate other efforts and has added value.