ICH GUIDELINES FOR PHARAMACOVIGILANCE

Organization and objectives of ICH

The International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory
authorities and pharmaceutical industry to discuss scientific and technical aspects of
pharmaceuticals and develop ICH guidelines.
Objective of ICH-
1. To promote public health
2. To reduce cost of research work duplications.
3. To maintain and formulate guidelines on quality, safety and efficacy based regulations
for consumers.
4. Reduce cost of clinical trials and time consumption.
5. Harmonization of subject of pharmaceutical
Organization of ICH
Efficacy guidelines
 E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for
Long-TermTreatment of Non-Life Threatening Conditions
 E2B (R2) Maintenance of the Clinical Safety Data Management including Data Elements
for Transmission of Individual Case Safety Reports
 E2B (R3) Clinical Safety Data Management: Data Elements for Transmission of Individual
CaseSafety Reports
 E2C (R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed
Drugs
 E2C (R2) Periodic Benefit-Risk Evaluation Report
 E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited
Reporting
 E2E Pharmacovigilance Planning
 E2F Development Safety Update Report
 E2A Clinical Safety Data Management:
Definitions and Standards for Expedited
Reporting
What should be reported:
• Single cases of Serious, Unexpected ADRs
•Overdosing

Reporting time frames:

• For fatal or life threatening , unexpected ADRs(7 days)
•Serious , unexpected reactions ( 15 days)

How to report:
CIOMS Forms has been widely used
 Minimum criteria for reporting (key data elements for inclusioin in expedited reports of serious adverse drug
reactions:
•Patient details( Iinitials,Gender,Age,Weight,Height)
•Suspected Medicinal Products ( Batch number,dosage form and strength ,Route of administration,Starting date and
Time of day,Stopping date and time , duration of treatment,Indications for which suspect medicinal product was
prescribed or test)
•Other treatmentr(concomitant medicinal products and non medical products therapies,provide the same information
as for the suspected productinformation
•Details of suspected adverse drug reactions ( Start date and time of onset of reaction ,Stop date and time or duration
of reaction,Dechallenge and rechallenge information)
•Administrative and sponsor/ Company details( Name and address of sponsor ,Date event report was first received by
sponsor/ manufacturer,country in which event occurred,Source of report).
Post approval safety management:
Post approval safety management (E2D) guideline was finalized in 2003 and provides a
standardized procedure for post approval safety data management, including post approval
expedited reporting to the concerned authority.
It parallels and adds to the E2A document, which covered preapproval (clinical trial) safety
data management, by covering postmarketing safety data management.
This document standardizes data management of cases from consumers, literature, internet,
and other types of postmarketing cases.
 ( ICSR )
INDIVIDUAL CASE SAFETY REPORTS

• IT IS AN ADVERSE EVENT REPORT FOR AN INDIVIDUAL PATIENT AND

IT IS ALSO A SOURCE OF DATA IN PHARMACOVIGILANCE PROCESS.
THESE REPORTS HELP FOR MAINTAINING THE DATA BASE OF AN
ADVERSE EVENT ON INDIVIDUAL BASES IN WHO) THIS DOCUMENT
ALSO HELPS TO OBSERVE AND MAINTAIN DATA OF EXPECTED OR
UNEXPECTED REPORTS.
STANDARDS FOR EXPEDITED REPORTING

1. SERIOUS, EXPECTED ADVERSE DRUG REACTIONS (WHICH CAN VARIES AMONG THE COUNTRIES)
2. SERIOUS AND UNEXPECTED ADRS.
3. NON SERIOUS AND UNEXPECTED ADRS.
4. NON-SERIOUS AND EXPECTED ADRS
5. LACK OF EFFICACY
6. OTHER OBSERVATIONS & OVERDOSE
IMPORTANT INFORMATION FOR MAKING A VALID
ICSRS.
1. ADMINISTRATIVE INFORMATION :- COUNTRY, TYPE OF REPORT, QUALIFICATION
OF REPORTER, LITERATURE REFERENCE.
2. PATIENT INFORMATION :- AGE OF PATIENT, SEX, MEDICAL HISTORY OF PATIENT,
SERIOUSNESS OF EVENT, DEATH INFORMATION, CHILDHOOD INFORMATION.
3. REACTION INFORMATION :- ORIGINALITY OF EVENTS OR REACTION, DATE OF
ONSET OF ACTION, SERIOUSNESS, LABORATORY TESTS.
4. DRUG INFORMATION OR HISTORY :- DRUG USED BY PATIENT WITH THEIR
CHARACTERIZATION, TRADE NAME, DATE OF STARTING USAGE AND STOP USAGE
OF DRUG SO THAT INVESTIGATOR SHOULD CALCULATE THE DURATION OF DRUG
TAKEN AND THEIR ONSET OF TIMING.
THIS INCLUDES SOME OTHER POINTS WHICH ARE:
1. DRUG INFORMATION WITH DRUG ADMINISTRATION
DATA
2. DRUG ONSET TIME
3. DOSE INDICATION
4. CHALLENGES AND RE-CHALLENGES OF DRUG
 SUBMISSION OF ICSR’S :
• THE SUBMISSION OF ICSR’S IS EASY IN NOWADAYS. AFTER COLLABORATION WITH VARIOUS
NATIONAL AND PHARMACOVIGILANCE CENTERS IT IS EASY TO SUBMIT THE ADR REPORTS FROM
THE ANY PART OF THE WORLD. EACH AND EVERY COUNTRY HAS THEIR ADR CENTERS WHICH
ARE CONNECTED WITH THE WHO CENTER DATABASE. WE CAN REPORT ELECTRONICALLY BY
THE VARIOUS OFFICIAL SITES OF CENTERS OR WHO. THERE ARE SOME GUIDELINES ACCORDING
TO THEM AN ICSR CAN UPLOAD ON THE SITES OF DA, OR NO DATABASE. THESE GUIDELINES ARE
GIVEN IN ICH GUIDELINES OR MAIN SITE OF ICH.
• FOR SUBMISSION OF INDIVIDUAL CASE STUDY REPORTS PLEASE GO TO THE FDA MAIN SITE AND
FOLLOW THE GIVEN INSTRUCTION ON THE SITE
WWW.FDA.GOV
 PSUR
PERIODIC SAFETY UPDATE REPORT
• PERIODIC REPORTING IS THE PREPARATION AND SUBMISSION OF SAFETY
INFORMATION LIKE
• 1 ADVERSE EVENT
• 2LACK OF EFFICACY
• 3 MEDICATION ERROR
• 4 ACCIDENTAL EXPOSURE
• • SAFETY INFORMATION SUBMISSION OF MEDICINAL PRODUCT ON A PERIODIC OR TIMELY BASIS
FOR EXAMPLE
• EVERY YEAR
• EVERY 3 MONTHS
•EVERY 6 MONTHS.

• MAJOR TYPES OF PERIODIC REPORTS ARE

• DSUR- DEVELOPMENT SAFETY UPDATE REPORT•
• ITS A PERIODIC REPORT FOR DRUGS UNDER DEVELOPMENT(INCLUDING MARKETED DRUGSTHAT
ARE UNDER FURTHER STUDY).•
• IT IS SUBMITTED ON ANNUAL BASIS.
• • IT REPLACES THE CURRENT IND ANNUAL REPORT (AR) IN US AND ANNUALSAFETY
REPORT(ASR) IN EU
• • PSUR - PERIODIC SAFETY UPDATE REPORT
• • PADER - PERIODIC ADVERSE DRUG EXPERIENCE REPORT
 DIFFERENCE BETWEEN PSUR & PBRER

PSUR PBRER

• NO BENEFIT EVALUATION • BENEFIT EVALUATION

• RISK EVALUATION ( RISK • RISK EVALUATION (RISK

MINIMISATION PROCEDURES FOR
LIMITED PRODUCTS)
• NO INTEGRATED RISK BENEFIT
ANALYSIS
MINIMISATION PROCEDURES FOR ALL
SIGNIFICANT RISK ASSOCIATED WITH
ALL THE PRODUCT)
• INTEGRATED RISK BENEFIT ANALYSIS
 PSUR
• • PSURS ARE IMPORTANT PHARMACOVIGILANCE DOCUMENTS APPLYING TO
DRUG ALREADY APPROVED FOR MARKETING - REGULARLY UPDATING
REGULATORY AUTHORITIES ON THE WORLDWIDE SAFETY EXPERIENCE OF
APPROVED DRUGS.
GOOD CLINICAL
PRACTICES (GCP)

By Rajat madaan
PHARMACOVIGILANCE
PLANNING GUIDELINES

By Rajat madaan