REPORTING CRITERIAS TO

HEALTH AUTHORITY
PRESENTED BY
DASARI KRISHNA
Reporting criteria:
It is recommended to much information to be collected at the time of the initial report for the purpose regulatory reporting It
has 4 key elements of ADR cases . They are
An identifiable reporter
An identifiable patient
An adverse reaction
Suspected drug or product
Reporting time frame :
The expedited reporting of serious and unexpected ADR requires as soon as possible
This reporting should not be later than 15 calendar days of initial receipt information by MAH
The regulatory reporting time is start on the date when any of the MAH first receiving a case report
that fulfils minimum criterias as well be reporting
This date should be consider as day zero
When additional medically relevant information is received for previously reported case , the
reporting time clock is considered to begin again for submission of the follow up report
SUSAR : Suspected unexpected serious adverse reactions
In Eu clinical trials or trials in any country or spontaneously or publication should be reported to
health authority
The fatal or life-threatening SUSAR should be reported <7 days from receipt follow-up <8 or more
days
Other SUSAR and safety issues should be reported to health authority in <15 days and follow up as
soon as possible

Non-serious ADR:
Cases of non serious ADRs ,whether expected or not
Non-serious ADR should be included in the periodic safety update report according to the ICH E2C
guidelines
1. PSUR : It is good pharmacovigilance Module 7. The periodic safety update report is one part of the New European
pharmacovigilance legislation
The PSUR is the benefitICH E2C guidelines
Objective of PSUR :
The main objectives is present 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
The evaluation of risk assessment should be under taken in the content ongoing pharmacovigilance and risk
management
IBD and Data lock point :
The date the first marketing approval for the any country in the world is the International Birth Date
The data lock point is date designated of the cut off for data to be included .It is based on (IBD)

Reporting time lines :

MAH should submit PSURs to EMA
Within 70 calendar days of the data lock point for PSURs covering intervals up to 12 months
Within 90 calendar days of the data lock point for PSURs covering intervals in excess of 12 months

PSURs should provide greater emphasis on analysis of cases reports to include

Scientific evaluation of the benefit risk profile

Summaries of relevant scientific / clinical data available sales / prescription data
Preparation of PSUR :
Prepare single of PSUR for all medicinal products containing the same active substance with information on all
indications , routes ,forms and dosing whether authorized under different names / or procedures
2. DSUR overview :
The DSUR present an annual review and evaluation of safety information
Its focus on clinical trials drugs like drugs ( include vaccines and biologics
Safety and welfare of the subject
Investigational drug data should be equal to comparator drug
Subject US annual report EU annual report

Data lock point Effective date if IND IBD

Purpose IND progress report CT safety report

Short term trials <1 year from end of the study

Reports contain all study info:
Protocol
Purpose
Patient population

3. PBRER (periodic benefit risk Evaluation Report)

ICH published the ICH E2C guidelines on periodic benefit-risk evaluation Report .
The PBRER is a new report with some concepts and principles from the PSUR and DSUR as well as new information on
benefits and risks. The PBRER emphasizes cumulative information as well as information in the reporting intervals.
4. PERIODIC ADVERSE DRUG EXPERIENCE REPORTS ( PADER) :
How frequently are post approval cumulative reports of safety submitted ?
The FDA generally requires PADERs quarterly during the first 3 years after the medicine is approved and annual report s
thereafter.
The EMA requires PSUR every 6 months for 2 years ,annually for the 3 following years ,and then every 5 years (at the time
of renewal of registration).
In japan authorities requires a survey of a cohort of a few thousand patients established by certain number of identifiable
institutions during the 6 years following approval , with the systematic information reported annually in this cohort.
Analysis of the 15 days reports submitted during the reporting period.
EudraVigilance ( European Union drug regulatory authorities Pharmacovigilance ):
The European medicine agency is responsible for the development ,maintenance ,and coordination of EudraVigilance, a
system designed for the reporting of suspected side effects .
Reports submitted to EudraVigilance include suspected side effects of medicines reported during both the pre and post
authorization phases . The system allows the detection of signals of suspected side effects that were previously unknown ,
and of new information on known side effects
Data collected in Eudra Vigilance :
pre authorization module :
Suspected unexpected serious adverse reactions ( SUSARs ) reported by sponsors CT
Data from investigational CT
Post authorization module :
Suspected serious side effects
Healthcare professionals spontaneous reporting
Post-authorization studies
World wide scientific literature
Transmission of an infectious agent via medicinal product.
THANK U