Need for PSUR

Limited No. Of patients in clinical trial

Exclusion of certain patient at risk

Lack of significant long term treatment

Limitation of concomitant medication

 Need for PSUR

Closely Monitored

Priorities will be given

during 1st year of
to both serious and
commercialization
unexpected
Surveillance of marketed Drugs
 PSUR

Timely detection and

Record drug information
mutual exchange of safety
from different resources
data
 Why PSUR?

Significant Periodic
Whether
Relevant Relate data variation in opportunity
changes
new safety to patient demography for overall
required in
information exposure related to safety
PI
safety evaluation
 Timelines for PSUR

PSUR INDIA

First 2 years Every 6months Next 2 years annually

PSUR US

First 3 years Every 3 months Annually

PSUR EU

First 2 years Every 6months Next 3 years annually

 General Principles

One report for All dosage form Fixed combination

active substance and formulation in drugs
one PSUR
General Scope of information
All clinical and
nonclinical safety
data

ADR not AE

Spontaneous
Reports

Clinical study and

literature cases

Lack of efficacy

Increase in
frequency of
documented ADR
International birth date

International Birth Date

Date of first marketing authorization for the
product granted to any company in any
country
MAH Submit PSUR within 60 days of data
lock point
Reference Safety Information

CCDS-Company Core Data Sheet

CCSI-Company Core Safety Information
Listed
Unlisted
Expectedness
 Source of Information

Direct report to MAH

Literature

ADR Reporting of Regulatory Authorities

Epidemiological database
 Line listing and summary Tabulation

All non All non

Individual
Summary All serious serious serious
case line
Tabulation ADRs unlisted listed
listing
ADRs ADRs
 Title Page

Periodic Safety Update Report for Product

MAH name and address
Period covered by this report
International Birth Date
Date Of Report
 Table Of Content
Introduction

World Wide Market Authorization Status

Update of Regulatory Authority or MAH action taken for safety reason

Patient Exposure

Presentation of Individual case histories

Studies

Other information

Overall Safety Evaluation

 Introduction

This is a PSUR of Paracetomol covering the period

____________t0_____________

The report summarizes all adverse reaction reported in

connection of ABC Pharma

ABC PARAT got approval for 500mg and 650mg

World wide market authorization status

• Date of marketing Authorization

• Limits of indication and safety

• Treatment indication and Population Covered

• Lack of Approval

• Withdrawal

• Launch Date

• Trade name
Update of Regulatory Authority
MA Withdrawal and
Suspension

Failure to obtain
marketing authorization

Clinical trial suspension

Dosage Modification

Change in target
population or indication

Formulation change
Reference safety information

Changes to CCSI

New Contraindication

New Precaution

New Warning

New ADR

New Reaction
Patient’s exposure

Number of prescribed drugs.

Number of drugs sold.

Presentation of the line listing
MAH case reference number

Country

Source

Age & sex

Daily dose

Date of onset

Description of event

Patient outcome : resolved, fatal, improved, unknown

comments
 Presentation of the line listing

MAH Country Source Age Daily Date of Date of Description Patient Comments
Ref . & sex dosage onset treatment outcome
No

01340 USA Spont 31 , f 500mg 02.05.09 14.05.09 Bleeding Resolved Nil

tds To gastric ulcer
20.05.09

01351 UK Liter 29 , m UNK UNK UNK Oral thrush Ongoing Concomitant

steriod may
be the cause
MAH analysis of individual case histories

Brief comments on
Unanticipated
data concerning
findings
individual cases.
 Studies

Completed
Clinical Nonclinical Epidemiological
studies

Studies specifically planned

Studies in progress

Published studies
Newly analyzed company sponsored
studies
Studies
containing
Clinical Non clinical
important
report study reports.
safety
information

Study Study
design results
 Published safety studies

Relevant published
abstracts from
Reports in
meeting Publication
scientific/ medical
containing reference.
literature.
important safety
finding.
 Other information

Efficacy related information.

Product used to treat serious or life
threatening diseases.
Medically relevant lack of efficacy reporting.
 Late breaking news

Any important new

information received
after database was
frozen for review and Important follow up
report preparation. data.

Significant new
cases.
 Overall safety evaluation

Concise analysis of Change in

Serious unlisted
data presented so characteristics of
reaction.
far. listed reaction.

Increased reporting
Non- serious
frequency of listed
unlisted reaction.
reaction.
Overall safety evaluation

Effects of long term

Drug interaction
treatment

Experience in
Experience with
special patient
overdose
groups

Positive or negative
Drug abuse or experience with
misuse pregnancy or
lactation