The Development safety update report (DSUR) is pre-marketing periodic report which covers safety information of drugs, biological, vaccines and combo products under development (including marketed drugs that are under further study) among the ICH regions.
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| Development Safety Update Report (DSUR) |
DIBD (Development International Birth Date)
DIBD is the date of first approval (or authorisation) for conducting an interventional clinical trial in any country.
Objective of a DSUR
The main objective of a DSUR is to present an annual review and evaluation of pertinent safety information collected during the reporting period to:
(1) Summarize the current understanding and management of identified and potential risks;
(2) Describe new safety issues that could have an impact on the protection of clinical trial subjects;
(3) Examine whether the information obtained by the sponsor during the reporting period is in accord with previous knowledge of the product’s safety;
(4) Provide an update on the status of the clinical investigation/development programme.
Scope of DSUR
The DSUR should provide safety information from all ongoing clinical trials that the sponsor is conducting or has completed during the review period including:
• Clinical trials conducted using an investigational drug whether with or without a marketing approval, i.e., human pharmacology, therapeutic exploratory and therapeutic confirmatory trials (Phase I – III);
• Clinical trials conducted using marketed drugs in approved indications, i.e., therapeutic use trials (Phase IV);
• Other therapeutic use of an investigational drug; and
• Comparability trials conducted to support changes in the manufacturing process of medicinal products.
When should a DSUR be prepared?
A sponsor overseeing more than one clinical trial of a single investigational drug should prepare one DSUR for that drug with a single data lock point (DLP) wherever possible. If this is not possible, an explanation should be provided in the covering letter.
Periodicity and DLP of DSUR
The DSUR should be submitted no later than 60 calendar days from the DSUR data lock point. The data lock point of the DSUR should be based on the date of the sponsor’s first authorisation to conduct a clinical trial in any country. This date is termed the “Development International Birth Date” (DIBD).
DSUR for Combination products
In general, a single DSUR should be prepared for clinical trials involving a fixed combination product. For trials involving drug combinations that are not fixed, it can be appropriate to prepare a stand-alone DSUR. Alternatively, information on the multidrug regimen trials can be included in the DSUR of one or all of the components.
Reference Safety Information
The Investigator’s Brochure (IB) in effect at the start of the reporting period should serve as the reference safety information for the DSUR for an investigational drug whether or not the drug has a marketing approval.
The report should clearly indicate the version number and date of the IB used for this purpose. If the IB has been revised during the reporting period and not previously submitted to the relevant regulatory authority, the sponsor should provide a copy of the revised version of the IB as an attachment to the DSUR.
Format and Presentation of DSUR
Table of Contents
Title page
Executive Summary
Table of Contents
1. Introduction
2. Worldwide Marketing Approval Status
3. Actions Taken in the Reporting Period for Safety Reasons
4. Changes to Reference Safety Information
5. Inventory of Clinical Trials Ongoing and Completed during the Reporting Period
6. Estimated Cumulative Exposure
6.1 Cumulative Subject Exposure in the Development Programme
6.2 Patient Exposure from Marketing Experience
7. Data in Line Listings and Summary Tabulations
7.1 Reference Information
7.2 Line Listings of Serious Adverse Reactions during the Reporting Period
7.3 Cumulative Summary Tabulations of Serious Adverse Events
8. Significant Findings from Clinical Trials during the Reporting Period
8.1 Completed Clinical Trials
8.2 Ongoing Clinical Trials
8.3 Long-term Follow-up
8.4 Other Therapeutic Use of Investigational Drug
8.5 New Safety Data Related to Combination Therapies
9. Safety Findings from Non-interventional Studies
10. Other Clinical Trial/ Study Safety Information
11. Safety Findings from Marketing Experience
12. Non-clinical Data
13. Literature
14. Other DSURs
15. Lack of Efficacy
16. Region-Specific Information
17. Late-Breaking Information
18. Overall Safety Assessment
18.1. Evaluation of the Risks
18.2 Benefit-risk Considerations
19. Summary of Important Risks
20. Conclusions
Appendices to the DSUR
For more details on DSUR, please read below documents:
Overview of ICH E2F –Development Safety DevelopmentSafety Update Report (DSUR)
Regards,
PV Drug Safety Academy