The document details the Periodic Safety Update Report (PSUR), focusing on its objectives, principles, and differences from other periodic reports like PADER and PBRER. It outlines the structure and requirements for PSUR submissions, emphasizing the need for regular updates based on the latest safety data. Additionally, it discusses the importance of PSUR in pharmacovigilance for maintaining drug safety and regulatory compliance.

1. TOPIC – PSUR
Presented By : Mr.Sourav Chander
Reg.no. 71910684
Under Guidance of : Ms.Jagpreet
kaur (ass. Proff.)
PSUR-Periodic
Safety Update
Report

2. CONTENT
• Periodic Reporting
• PSUR
• Major types of Periodic Reports
• Differences between PSUR and PADER
• Differences between PSUR and PBRER
• The frequency of these reports
• PSUR OBJECTIVES
• Principles of PSUR
• The content and format of PSUR

3. PERIODIC REPORTING
Periodic Reporting is the preparation and submission of
SAFETY INFORMATION
LACK OF
EFFICACY
MEDICATION ERRORS
OFF LABEL USES
Withdrawal
symptoms
ADVERSE
EVENTS
ACCIDENTAL
EXPOSURE
Product Quality
Issues

4. PSUR
SAFETY INFORMATION SUBMISSION OF
MEDINICAL PRODUCT on a periodic or timely
basis e.g
 Every year or
 every 3 months or
 every 6 months.

5. MAJOR TYPES OF PERIODIC
REPORTS ARE:
DSUR- Development Safety Update Report
• It’s a periodic report for drugs under
development(including marketed Drugs that are under
further study).
• It is submitted on annual basis.
PSUR-Periodic Safety Update Report
PADER-Periodic Adverse Drug Experience Report
PBRER: Periodic Benefit Risk Evaluation Report

6. DIFFERENCES BETWEEN PSUR
AND PADER ARE OUTLINED
BELOW:
PSUR PADER
Approved by worldwide Agencies Approved by US FDA
Adverse events occuring 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.

7. The guidelines for PSUR were revised 2012
With the
recognition of the
fact that
Assessment of the risk of a
medicinal product is more
meaningful when evaluated
in context of its Benefits.
Hence the report format of PSUR
CHANGED
(Periodic Benefit Risk Evaluation Report: ICH E2C (R2)),
PBRER

8. Is an aggregate safety report that is
accepted worldwide including the
European Union, Japan, and Canada.
PSUR/PBRER

9. Though US-FDA recommends periodic submission of a
But Marketing Authorization Holder(The company that is
authorized to sell the drug) can submit
Along with NDA listings (also called US Supplement/FDA
PSUR) in place of PADER after obtaining a waiver.
PADER

10. SOME DIFFERENCES BETWEEN PSUR AND
PBRER ARE:
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.

11. THE FREQUENCY OF THESE
REPORTS IS:
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
PADER
Quarterly for first 3 years followed by
annually
PBRER Half-yearly for first 2 years followed
by Annually

13. PSUR
• PSURs are important pharmacovigilance documents
applying to drugs already approved for marketing-regularly
updating regulatory authorities on the worldwide safety
experience of approved drugs.

14. A tool for post-
authorization evaluation
PSUR
OBJECTIVES
Assessment of the
benefit-risk balance of
the medicinal product
Recommendations for any
necessary changes to the
product information or risk
management plan.
Present a comprehensive,
concise and critical analysis
of the risk-benefit balance
of the medicinal product
To provide information to
regulatory authorities for
their benefit-risk
assessment
To facilitate
communication with
healthcare professionals
and patients about the
safe use of the product

15. PRINCIPLES OF PSUR
Data collection: PSUR
should be based on the
latest available safety data
from all relevant sources,
including clinical trials,
post-marketing surveillance,
and scientific literature.
Continual evaluation: PSUR
should be updated regularly
to reflect any new safety
data and to ensure the
ongoing evaluation of the
product's safety profile
throughout its lifecycle.
Compliance: PSUR should
comply with regulatory
requirements and
guidelines.
Communication: PSUR
should provide relevant
safety information to
healthcare professionals,
regulatory authorities, and
patients as appropriate.
Risk management: PSUR
should evaluate the
effectiveness of risk
management measures and
propose new measures if
necessary.
Benefit-risk assessment:
PSUR should provide an
assessment of the product's
benefit-risk balance based
on the latest safety data and
the product's intended use.

17. THE CONTENT AND FORMAT OF PSUR
• The content and format of PSURs are specified in the
International Council for Harmonisation (ICH) guideline E2C(R2).
• It is a pharmacovigilance document that provides an evaluation
of the safety of a medicinal product over a specific period of
time.
• The PSUR is submitted by the marketing authorization holder
(MAH) to the regulatory authorities at defined intervals

18. THE CONTENT AND
FORMAT OF PSUR
Part I: Title page including
signature
Part II: Executive Summary
Part III: Table of Contents
PSUR
Part1 Part2 Part3

19. PSUR TITLE PAGE
Name of the medicinal product(s)& substance
International birth date (IBD)
Reporting interval
Date of the report
Marketing authorisation holder details

20. PSUR EXECUTIVE SUMMARY
CONCISE SUMMARY OF CONTENT
Purpose to Provide
IMPORTANT INFORMATION
INCLUDE
 Medicinal products, therapeutic classes ,mechanism(s) of action,, indication(s), pharmaceutical
formulation(s),dose(s) and route(s) of administration;
 Number of countries in which the medicinal product is authorised;
 Summary of the overall benefit-risk analysis evaluation
 Conclusions.

21. TABLE OF CONTENTS
• 1.Introduction
• 2. Worldwide marketing authorisation status
• 3.Actions taken in the reporting interval for safety reasons
• 4. Changes to reference safety information
• 5. Estimated exposure and use pattems
• 5.1. Cumulative subject exposure in clinical trials
• 5.2. Cumulative and interval patient exposure from
marketingexperience
• 6. Data in summary tabulations
• 6.1. Reference information
• 6.2. Cumulative summary tabulations of serious adverse events
fromclinical trials
• 6.3. Cumulative and interval summary tabulations from post-
marketing data sources

22. • 7. Summaries of significant findings from clinical trials during thereporting interval
• 7.1 Completed clinical trials
• 7.2. Ongoing clinical trials
• 7.3. Long-term follow-up
• 7.4. Other therapeutic use of medicinal product
• 7.5. New safety data related to fixed combination therapies
• 8. Findings from non-interventional studies
• 9. Information from other clinical trials and sources
• 10. Non-clinical Data
• 11. Literature
• 12 . Other periodic reports
• 13. Lack of efficacy in controlled clinical trials
• 14. Late-breaking information
• 15. Overview of signals: new, ongoing or closed

23. 16. Signal and risk evaluation
16.1. Summaries of safety concems
16.2. Signal evaluation
16.3. Evaluation of risks and new information
16.4. Characterisation of risks
16.5. Effectiveness of risk minimization (if applicable)
17. Benefit evaluation
171. Important baseline efficacy and effectiveness information
17.2. Newly identified information on efficacy and effectiveness
17.3. Characterisation of benefits
18. Integrated benefit-risk analysis for authorised indications
18.1. Benefit-risk context - Medical need and important alternatives
18.2. Benefit-risk analysis evaluation
19. Conclusions and actions
20. Appendices to the PSUR