Health Canada-MHRA Guideline: Increasing Transparency When Presenting Safety Information in the DSURPublished on August 17, 2021
On July 6, 2021, Health Canada and the Medicines and Healthcare products Regulatory Agency (MHRA) jointly published a Guideline on how to increase transparency when presenting safety information in the Development Safety Update Report (DSUR): region-specific requirements for Canada and the United Kingdom, with the aim to protect patient safety in clinical trials by improving the quality of safety information provided in Development Safety Update Reports (DSURs). The development of this guideline is part of a global collaborative effort and draws from principles outlined in existing international standards, which include:
- International Conference on Harmonisation (ICH) Guidance E2F (finalized under Step 4 in August 2010);
- Development Safety Update Reports (DSUR): Harmonizing the Format and Content for Periodic Safety Report during Clinical Trials (Council for International Organizations of Medical Sciences [CIOMS] Working Group VII, 2006); and
- Relevant clinical trial legislation in each country.
Currently, DSURs that are submitted for review include listings of serious adverse events and reactions, but do not include detailed safety assessments for previous or newly identified safety concerns during the reporting period. This presents a challenge for regulators in ensuring safety concerns have been thoroughly investigated and whether appropriate risk-mitigating measures have been taken for the use of the investigational drug in the trial.
The new guidelines, which apply to both marketed and non-marketed medicines undergoing clinical trials, outline the requirements for DSURs submitted to Health Canada and the MHRA. Notably, it describes how sponsors should present comprehensive safety information collected during the reporting period. In the region-specific information section, sponsors must provide a summary of the process for reviewing the safety data included in the DSUR, including how the safety information was reviewed in light of the cumulative safety profile of the investigational drug. Region-specific information must also describe how the sponsor evaluated each signal identified during the reporting period and how signal-related decisions were made (e.g. whether a signal is considered opened or closed).
With the publication of these new guidelines, increased safety data transparency in DSURs has the potential to facilitate regulatory review and hopefully reduce the volume of requests for information from health authorities. Over time, it will be interesting to observe the true impact of these guidelines to the regulatory review of DSURs, especially with other health authorities (e.g. Medsafe in New Zealand) reviewing their national legislation and seeking to align with the new guidance.
Author: Lydia To
- Guideline: increasing transparency when presenting safety information in the Development Safety Update Report (DSUR): region-specific requirements for Canada and the United Kingdom. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/increasing-transparency-presenting-safety-information-development-safety-update-report-regions-requirements-canada-united-kingdom.html
- Clinical trials for medicines: manage your authorisation, report safety issues. https://www.gov.uk/guidance/clinical-trials-for-medicines-manage-your-authorisation-report-safety-issues#development-safety-update-reports-dsurs
To Distribute or Not to Distribute? Health Canada’s Guide to distributing drugs intended for the Canadian market for consumption or use outside Canada
Further to Health Canada’s amendments to the Food and Drug Regulations (FDR) to make the provisions under the one-year Interim Order respecting drug shortages (safeguarding...
Health Canada Draft Revised Guidance Documents on Post-NOC Changes - Quality for Consultation
On August 6, 2021, Health Canada issued five draft revised Guidance Documents on Post-Notice of Compliance (NOC) Quality Changes for stakeholder consultation. The...