DEVELOPMENT SAFETY UPDATE REPORT IN PHARMACOVIGILANCE

 WHAT IS DSUR?

The DSUR is the pre-marketing periodic safety update report. It is the annual clinical trial safety report (for the adverse reactions observed during clinical studies) which is submitted to health authorities among the ICH regions.

DSUR is submitted instead of annual clinical trial safety reports in US and in EU.

A DSUR is the pre-marketing equivalent of the post-marketing Periodic Safety Update Report (PSUR).

PURPOSE OF DSUR

  • During the clinical development of an investigational drug, periodic analysis of safety information is crucial to the ongoing assessment of risk to trial subjects. 

  • It is also important to inform regulators and other interested parties (e.g., ethics committees) at regular intervals about the results of such analyses and the evolving safety profile of an investigational drug, and apprise them of actions proposed or being taken to address safety concerns.

  • This purpose is served by a DSUR.US and EU regulators consider that the DSUR, submitted annually, would meet national and regional requirements currently met by the US IND Annual Report and the EU Annual Safety Report, respectively, and can therefore take the place of these existing reports.

OBJECTIVE

The main objective of a DSUR is to present an annual review and evaluation of pertinent safety information collected during the reporting period to:

  • Summarize the current understanding and management of identified and potential risks.

  • Describe new safety issues that could have an impact on the protection of clinical trial subjects.

  • Examine whether the information obtained by the sponsor during the reporting period is in accord with previous knowledge of product’s safety

  • Provide an update on the status of clinical investigation/development program.


A DIAGRAM SHOWING THE WORK OF DSUR


WHEN A DSUR SHOULD BE PREPARED

  • A DSUR should be prepared after the first authorization of a clinical trial worldwide.

  • A copy of DSUR should be submitted to each concerned European Member State (MS) if a clinical trial is authorized in this MS for the investigational drug.

  • The dates of DSUR submission can be synchronized by preparing a PSUR international.

  • The DSUR submission should not be longer than 1 year.

  • The DSUR is always submitted on a yearly basis.

  • Also it is not allowed to change the submission date given by Regulatory Authorized.

FEW MORE POINTS ABOUT DSUR

  1. A single DSUR should be prepared for clinical trials involving a fixed drug combination.

  2. For clinical trials involving drug combination a stand-alone DSUR can be prepared.

  3. Drug medical device combination DSUR needs to prepare if therapeutic effect is achieved either by drug or medical device.

Reference Safety Information (RSI) Investigation brochure (IB) serves as the RSI for an investigational drug irrespective of its marketing authorization status.

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