The document outlines various types of aggregate safety reports, including preapproval reports like developmental safety update reports (DSUR) and post-approval reports such as periodic safety update reports (PSUR) and periodic benefit-risk evaluation reports (PBRER). It details the objectives, structures, and reporting timelines for these documents, which aim to evaluate the safety and risk-benefit balance of medicinal products throughout their lifecycle. Additionally, it highlights the frequency of submissions required for each report type and provides comparative insights between them.

1. AGGREGATE
REPORTING

4. DIFFERENT TYPES OF AGGREGATE REPORTS
 Preapproval aggregate reports are:
 Developmental Safety Update Report{DSUR}
 Investigational New Drug{IND} report in United States & Annual Safety
Report{ASR} in Europe are also getting replaced by DSUR
 Post approval aggregate reports are:
 Periodic Safety Update Report{PSUR} OR
 Periodic Benefit Risk Evaluation Report{PBRER}
 Periodic Adverse Drug Experience Report{PADER}

5. BENEFITS OF AGGREGATE REPORTING

6. DRUG SAFETY UPDATE REPORT
 Drug Safety Update Reports{DSURs} are new , intentionally-harmonized , safety
documents covering the safety summary of medicinal products during their
development or clinical trial phase.
 OBJECTIVES
 The potential risks are summarized based on the current understanding and
management.
 Examine changes in the product safety profile.

7. STRUCTURE OF DSUR
TABLE OF CONTENTS
TITLE PAGE
EXECUTIVE
SUMMARY

8. REPORTING TIMELINES
 Should be submitted no later than 60 calendar days from the DSUR data lock
point
The DSUR presents an annual reviews and evaluation of safety information
• It focus on clinical trial drugs like drugs, vaccines and biologics.
• Safety and welfare of the subjects
• Investigational drug data should be equal to comparator drug.

9. PERIODIC SAFETY UPDATE REPORTS{PSUR}
Periodic Safety Update Reports{PSUR’s} are pharmacovigilance documents intended to
provide an evaluation of the risk-benefit balance of a medicinal product for submission by
marketing authorization holders{MAH’s} at defined time points during the post-authorization
phase.
OBJECTIVE:-
 To present a comprehensive and critical analysis of the risk-benefit balance of the
medicinal product taking into account new or emerging information in the cumulative risk-
benefit analysis.
 This evaluation of risk-benefit assessment should be undertaken in the context of ongoing
pharmacovigilance and risk management.

10. CONTENT AND FORMAT
TABLE OF CONTENTS
TITLE PAGE
EXECUTIVE SUMMARY

11. REPORTING TIMELINES
 Within 70 calendar days PSURs intervals up to 12 months
 Within 90 calendar days – if in excess of 12 months
 Timeline for ad hoc PSURs requested by CA-timeline will be provided by CA or
else 90 days.

12. PERIODIC BENEFIT RISK EVALUATION
REPORTS
 Periodic Benefit Risk Evaluation Reports (PBRERs) are pharmacovigilance
documents for preparation and submission by marketing authorization holders at
defined time points during the post-authorization phase with objective to provide a
comprehensive, concise and critical evaluation of the risk-benefit balance of a
medicinal product taking into account new or emerging information in the context
of cumulative information on risks and benefits
 OBJECTIVES:-
 To present overall benefit-risk profile.

13. FORMAT AND CONTENTS OF PBRER

14. REPORTING TIMELINE
 A Market Authorization Holder {MAH} is required to make the PBRER
submission:
 Every 6 months for the first 2 years after the product is marketed
 Once a year for the following 2 years

15. PERIODIC ADVERSE DRUG EXPERIENCE
REPORTS{PADERs}
 A PADER is a type of aggregate safety report required to be submitted by a
sponsor or marketing authorization holder (MAH) to the US Food and Drug
Administration (FDA) after obtaining marketing authorization approval.
 OBJECTIVE:-
 To provide summary data on safety profile of the drug and to update and evaluate
a medicine global data and provide information about drug safety

16. FREQUENCY OF THE REPORTS
REPORT NAME FREQUENCY
DSUR Annual
PSUR For EMA, every 6 months for 2
years and annually for 3 years
For PMDA, every 6 months for
3 years and then annually
PADER Quarterly for first 3 years
followed by annually
PBRER Half-yearly for first 2 years
followed by annually

17. PSUR PBRER
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 benefit analysis Integrated risk benefit analysis
DIFFERENCES BETWEEN PSUR AND PBRER
DIFFERENCES BETWEEN PSUR AND PADER
PSUR PADER
Approved by worldwide Agencies Approved by US FDA
Adverse events occurring around the
world
Adverse events occurring in the
U.S.(especially 15 day report)
Overall safety evaluations with specific
highlighting.
Non-Serious Adverse Events can be
exempted.

18. REFRENCES
 http://www.slideshare.net/TuracozHealthcareSolutions/periodic-safety-update-
reports-gvp-guidelines-and-changes?from_m_app=android
 https://gauravkantgoel.medium.com/periodic-safety-reports-76b452e0303a
 http://www.slideshare.net/RohithKNair/periodic-safety-update-report-
psur?from_m_app=android
 https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-
pharmacovigilance-practices-gvp-module-vii-periodic-safety-update-
report_en.pdf
 https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-2-f-
development-safety-update-report-step-3_en.pdf

19. Thank you
BOLLAM.SARIKA -007/0122
bollamsarika@gmail.com