Pharmacovigilance and ICH guidlines

PHARMACOVIGILANCEPHARMACOVIGILANCE
& ICH GUIDELINES& ICH GUIDELINES
Prepared by
Mr.C.STALIN.M.Pharm.,(Ph.D)
Technical Associate,
Adverse events Monitoring Centre,
Govt Kilpauk Medical college,
Chennai.

What is Pharmacovigilance??What is Pharmacovigilance??
Data gathering related to the
detection, assessment, understanding,
and prevention of adverse events.
Identifying new information about
hazards associated with medicines,
preventing harm to patients.

TermsTerms
Adverse Event (AE) – any untoward medical
occurrence that may present during treatment with a
pharmaceutical product but which does not
necessarily have a casual relationship with this
treatment.
Adverse Drug Reaction (ADR) – a response to a
drug which is noxious and unintended, and which
occurs at doses normally used in man.
Serious Adverse Event (SAE) – AE that is either
life-threatening, fatal, cause of prolong hospital
admission, cause persistent disability or concern
misuse or dependence.

E1 Clinical Safety for Drugs used
in Long-Term Treatment
The Extent of Population Exposure to Assess
Clinical Safety for Drugs Intended for Long-
Term Treatment of Non-Life Threatening
Conditions.
This document gives recommendations on the
numbers of patients and duration of exposure
for the safety evaluation of drugs intended for
the long-term treatment of non-life-
threatening conditions.

E2A-Clinical Safety Data
Management: Definitions and
Standards for Expedited Reporting
This document gives standard definitions and
terminology for key aspects of clinical safety
reporting.
It also gives guidance on mechanisms for
handling expedited (rapid) reporting of
adverse drug reactions in the investigational
phase of drug development.

E2B(R3)Clinical Safety Data
Management: Data Elements for
Transmission of Individual Case
Safety Reports
The ICH Steering Committee had taken a key
decision that technical specifications should no
longer be developed solely within ICH, but
should be created in collaboration with
Standards Development Organisations (SDOs)
to enable wider inter-operability across the
regulatory and healthcare communities.

E2B(R3) IWG Implementation:
Electronic Transmission of
Individual Case Safety Reports
In July 2013, the ICH Steering Committee
endorsed the establishment of the IWG on
E2B(R3) to assist with the implementation of
the E2B(R3) Implementation Guide
(published in July 2013) and help facilitate
transition from E2B(R2) to E2B(R3).

E2C(R2)Periodic Benefit-Risk
Evaluation ReportE2C, E2CA
This document gives guidance on the
format and content of safety
updates, which need to be provided
at intervals to regulatory authorities
after products have been marketed.

E2D Post-Approval Safety Data
Management: Definitions and
Standards for Expedited Reporting
This document provides a standardised
procedure for post-approval safety data
management including expedited reporting to
relevant authority. The definitions of the
terms and concept specific to post-approval
phase are also provided.
E2A definitions in clinical safety data
management was maintained in this
document as post-approval safety data
management, such as seriousness definition.

E2EPharmacovigilance
Planning
This was intended to aid in planning
Pharmacovigilance activities, especially in
preparation for the early postmarketing
period of a new drug .
The main focus of this Guideline is on a
Safety Specification and Pharmacovigilance
Plan that might be submitted at the time of
licence application.

E2F Development Safety Update
Report
The main focus of the DSUR is data from
interventional clinical trials (referred to in
this document as "clinical trials") of
investigational drugs including biologicals,
with or without a marketing approval,
whether conducted by commercial or non-
commercial sponsors.

E3Structure and Content of
Clinical Study Reports
This document describes the format and
content of a study report that will be
acceptable in all three ICH regions.
It consists of a core report suitable for all
submissions and appendices that need to be
available but will not be submitted in all
cases.

E4Dose-Response Information
to Support Drug Registration
This document gives recommendations
on the design and conduct of studies to
assess the relationship between doses,
blood levels and clinical response
throughout the clinical development of a
new drug.

E5(R1)Ethnic Factors in the
Acceptability of Foreign Clinical
Data
This document addresses the intrinsic
characteristics of the drug recipient and
extrinsic characteristics associated with
environment and culture that could affect the
results of clinical studies carried out in regions
and describes the concept of the "bridging
study" that a new region may request to
determine whether data from another region
are applicable to its population.

E6 Good Clinical Practice
Finalised
This Good Clinical Practices document
describes the responsibilities and
expectations of all participants in the
conduct of clinical trials, including
investigators, monitors, sponsors and
IRBs.

E6 Good Clinical Practice
Finalised
GCPs cover aspects of monitoring,
reporting and archiving of clinical trials
and incorporating addenda on the
Essential Documents and on the
Investigator's Brochure which had been
agreed earlier through the ICH process.

E7Studies in Support of
Special Populations
This document provides recommendations
on the special considerations which apply
in the design and conduct of clinical trials
of medicines that are likely to have
significant use in the elderly.

E8General Considerations for
Clinical Trials Finalised Guideline
This document sets out the general
scientific principles for the conduct,
performance and control of clinical
trials. The Guideline addresses a wide
range of subjects in the design and
execution of clinical trials.

E9 Statistical Principles for
Clinical Trials
This Bio statistical Guideline describes
essential considerations on the design and
analysis of clinical trials, especially the
"confirmatory" (hypothesis-testing)
trials that are the basis for
demonstrating effectiveness.

E10 Choice of Control Group and
Related Issues in Clinical Trials
This document addresses the choice of control
groups in clinical trials considering the ethical
and inferential properties and limitations of
different kinds of control groups.
 It points out the assay sensitivity problem in
active control equivalence / non-inferiority
trials that limits the usefulness of trial design
in many circumstances.

E11Clinical Investigation of
Medicinal Products in the
Pediatric Population
This document addresses the
conduct of clinical trials of medicines
in pediatric populations. This
document will facilitate the
development of safe and effective use
of medicinal product in pediatrics.

E12Principles for Clinical Evaluation
of New Antihypertensive Drugs
This therapeutic area document considers
the Clinical Evaluation of New
Antihypertensive Drugs. It provides a set of
"Principles" on which there is general
agreement among all three ICH regions
covering endpoints and trial designs.

E12Principles for Clinical
Evaluation of New
Antihypertensive Drugs
Since there are a few differences in the
requirements of the three regions that
have not been harmonised, this document
should be considered an "ICH Principle
Document" rather than an "ICH
Guideline".

E14The Clinical Evaluation of QT/QTc
Interval Prolongation and
Proarrhythmic Potential for Non-
Antiarrhythmic Drugs
 This document provides recommendations
to sponsors concerning the design, conduct,
analysis, and interpretation of clinical studies
to assess the potential of a drug to delay
cardiac repolarisation.

E15 Definitions for Genomic
Biomarkers, Pharmacogenomics,
Pharmacogenetics, Genomic Data
and Sample Coding Categories
This Guideline contains definitions of key
terms in the discipline of pharmacogenomics
and pharmacogenetics, namely genomic
biomarkers, pharmacogenomics,
pharmacogenetics and genomic data and
sample coding categories.

E16 Biomarkers Related to Drug or
Biotechnology Product Development:
Context, Structure and Format of
Qualification Submissions
The Guideline describes
recommendations regarding context,
structure, and format of regulatory
submissions for qualification of genomic
biomarkers, as defined in ICH E15.

E17General principle on
planning/designing Multi-
Regional Clinical Trials
This new guidance is proposed to provide
guidance on general principles on
planning/designing Multi-Regional
Clinical Trial (MRCT).

E18Genomic Sampling
Methodologies for Future Use
This new guidance is proposed to provide
guidance on genomic sample collection to
evaluate efficacy and safety of a drug for
regulatory approval.

Pharmacovigilance and ICH guidlines

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