AGGREGATE SAFTEY UPDATE REPORTS

Introduction

When a medicinal product is under investigation it is important to periodically analyse the safety profile of the investigational product in order to ensure the safety aspect of the trial subjects hence it is imperative to report to the health authorities and other concerned departments at regular intervals of time about the safety and risk of investigational product so that needed interventions can be provided correctly. PSUR, DSUR, and PBRER are the aggregate safety update reports.

PSUR (periodic safety update report)

PSUR is the pharmacovigilance documents that collect the data related to safety aspects of the marketed products worldwide. It contains an assessment of the risk benefit ratio of drugs at defined points in time after approval. Marketing authorization holders must submit the PSUR at defined intervals after the medicinal product is authorized.

PSUR mainly includes data on the benefits and the risks of medicines. The results of all studies carried out with the particular medicinal products. The main aim of periodic safety update report is to present an in-depth and critical evaluation of the benefit and risks balance of the product in the context of cumulative information. PSUR thus determines whether risks for medicines have been identified or whether the risk-benefit ratio of medicine then changed accordingly and the necessary measures can be decided taking into account public safety.

DSUR (Development safety update report)

This document is the periodic regulatory safety report which is used for the drugs which are under development and for the marketed products that are under further study (amongst the ICH regions). DSUR covers drugs biologicals, vaccines, and combo products. In simple words, DSUR encompasses a safety summary of medicinal products under investigation.

The prime objectives of DSUR is that it furnishes comprehensive annual analysis of the relevant safety information collected during the clinical trial about an experimental product whether or not it is marketed. This safety document communicates to the regulators and Ethics Committee at regular intervals about adequate monitoring and evaluation of the safety profile of the investigational product. The sponsor should present a DSUR report briefly and very clearly to the regulators in order to ensure that appropriate monitoring and evaluation of the investigational product is done. DSUR should be prepared after the first authorization of a clinical trial anywhere in the world.

DSUR mainly includes

  • The progress of the clinical investigation. 
  • Safety information of the product.
  • Issues that may impact the safety of the trial participants.
  • Brief statement about the present understanding and management of identified and potential risks.
  • Statement indicating whether the data from the current reporting period aligns with the known Safety information of the investigational product or not

PBRER (Periodic Benefit Risk Evaluation Report)

The Periodic safety update report was changed in the year 2012 and is now referred to as the Periodic Benefit and Risk Assessment Report (PBRER) in many countries. The PBRER would emphasize the benefit more than the PSUR, especially when making risk assessments. The main difference between PSUR and PBRER is in the below table.

PSURPBRER
No benefit evaluation.Benefit evaluation.
Risk evaluation (risk minimization procedures for limited products)Risk evaluation (Risk minimization procedures for all significant risks associated with all products).
No integrated risk benefits analysis.Integrated risk benefits analysis.

The prime objectives of the PBRER are: –

  • To contain an evaluation of new relevant information that became available to the market authorization holder (MAH) during the reporting interval in the context of cumulative information.
  • To examine whether new information is in accord with previous knowledge of the benefit and risk profile.
  • To summarize relevant new safety information that may impact the benefit and risk profile. 
  • To summarize any important new efficacy and effectiveness information.
  • To conduct an integrated benefit and risk (B/R) evaluation.