Ich Guidelines - Efficacy Series

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ICH GUIDELINES FOR QUALITY

CONTROL OF HERBAL DRUGS
(EFFICACY – E SERIES )
PRESENTED BY:
NANDANA .V
ROLL NO: 20
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EFFICACY GUIDELINES – ( E SERIES )
 These guidelines is concerned with the design, conduct,

safety and reporting on various aspects of clinical testing
in humanbeings.
 It also covers novel type of medicines derived from
biotechnological processes and the use of
pharmacogenetics /pharmacogenomics techniques to
produce better targeted medicines.
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E1 – Clinical safety for drugs intended for long term treatment
• The objective of this guideline is to present an accepted set of principles for the
safety evaluation of drugs intended for the long-term treatment of non-life-threatening
diseases.
• This guideline gives information on duration of drug exposure and it’s relationship to
both time and magnitude of occurrence of adverse effects.
• The clinical trial team includes pharmacologists , pharmaceutical scientists,
physicians, statisticians and nurses as well as social workers and other health care
professionals.
Phases of clinical trials
 Phase1 trials - In this researchers test an experimental drug or treatment in a small

group of healthy human volunteers ( 20-80) to evaluate it’s safety, minimum effective
dose, determine a safe dosage range and identify side effects.
 Phase 2 trials - In this experimental study drug or treatment is given to large group
of patients ( 50-300) to study the safety and effectiveness of an investigating
molecule or agent or intervention and evaluate how it affects the human body.
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Phase 3 trials- The experimental study drug or treatment is given to large

of people (250-1000) to confirm it’s effectiveness , monitor side effects ,
compare it to commonly used treatments and collect information .
 Phase 4 trial- It is conducted to further evaluate the long term safety and
effectiveness of a treatment. They usually take place after the treatment
has been approved for standard use.
E2A- E2F : Pharmacovigilance
E2A - Clinical safety data management
• This document gives standard definitions and terminology for key aspects
of clinical safety reporting.
E2B(R3) - Maintenance of the ICH guideline on clinical
safety data management
• The objective of the working group is to identify , define and standardize
the data elements for the transmission of individual case safety reports .
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E2C (R1) - Clinical safety data management: periodic safety

update reports for marketed drugs.
E2D – Post approval safety data management
• It is important to establish an internationally standardized procedure in order
to improve the quality of post-approval safety information and to harmonize
the way of gathering and reporting information.
E2E – Pharmacovigilance planning
• The main focus of this guideline is on a Safety Specification and
Pharmacovigilance Plan that might be submitted at the time of license
application.
E2F – Development safety update report
• It’s main focus is collection of data from clinical trials of investigational drugs
including biological with or without a marketing approval.
E3 - Structure and content of clinical study report
• The objective of this guideline is to allow the compilation of a single core
clinical study report acceptable to all regulatory authorities of the ICH regions.
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E4 – Dose response information to support drug registration
• This information can help identify an appropriate starting dose, the best way
to adjust dosage to the needs of a particular patient, and a dose beyond
which increases would be unlikely to provide added benefit or would produce
unacceptable side effects.
E5 – Ethnic factors in the acceptability of foreign clinical data
• This guidance is based on the premise that it is not necessary to repeat the
entire clinical drug development program in the new region and is intended to
recommend strategies for accepting foreign clinical data as full or partial
support for approval of an application in a new region.
E6 – Guideline for Good Clinical Practice
• Good Clinical Practice (GCP) is an international ethical and scientific quality
standard for designing, conducting, recording and reporting trials that involve
the participation of human subjects.
• The objective of this ICH GCP Guideline is to provide a unified standard for
the European Union (EU), Japan and the United States to facilitate the mutual
acceptance of clinical data by the regulatory authorities in these jurisdictions.
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E7- Studies in support of special populations: geriatrics

• 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 elderly.
E8 – General considerations for clinical trials
• This document set out "General Considerations for Clinical Trials" and
intended to describe internationally accepted principles and practices in
the conduct of both individual clinical trials and overall development
strategy for new medicinal products.
E9 – Statistical principles for clinical trials
• This guideline describes essential considerations on the design and
analysis of clinical trials , especially the confirmatory trials that are the
basis for demonstrating effectiveness.
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E10 – Choice of control group and related issues in clinical trials
• This guideline describes the general principles involved in choosing a control

group for clinical trials intended to demonstrate the efficacy of a treatment and
to discuss related trial design and conduct issues.
E11- Clinical investigation of medicinal products in the
pediatric population
• The goal of this guidance is to encourage and facilitate timely pediatric
medicinal product development internationally.
• This guidance provides an outline of critical issues in pediatric drug
development and approaches to the safe, efficient, and ethical study of
medicinal products in the pediatric population.
E12 – Clinical evaluation of new Anti hypertensive drugs
• It describes core principles for the evaluation of antihypertensive that are
accepted in the three ICH regions, but some region-specific differences
remain.
• The primary basis of assessment of efficacy of antihypertensive drugs is the
effect of the drug on systolic and diastolic blood pressures.
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E14 – Clinical evaluation for non Antiarrhythmic potential

• 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 repolarization.
• This assessment should include testing the effects of new agents on the
QT interval as well as the collection of cardiovascular adverse events.
E15 – Definitions for genomic biomarkers ,
Pharmacogenomics, Pharmacogenetics, Genomic data
• In order to develop harmonized approaches to drug regulation, it is
important to ensure that consistent definitions of terminology are being
applied across all constituents of the ICH.
• An agreement on definitions will facilitate the integration of the discipline
of pharmacogenomics and pharmacogenetics into global drug
development and approval processes.
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E16 –Qualification of genomic biomarkers

• The use of biomarkers has the potential to facilitate the availability of
safer and more effective drug or biotechnology products, to guide dose
selection and to enhance their benefit-risk profile.
• This guideline is based on previous experiences with submissions
containing biomarker data in the various regions.
• E17- Multi regional clinical trials
• With the increasing globalization of drug development, it has become

important that data from multi-regional clinical trials (MRCTs) can be
accepted by regulatory authorities across regions and countries as the
primary source of evidence, to support marketing approval of drugs .
• The purpose of this guideline is to describe general principles for the
planning and design of MRCTs with the aim of increasing the
acceptability of MRCTs in global regulatory submissions.
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E18 – Genomic sampling and the management of genomic data
• This guideline will facilitate the implementation of genomic studies by

enabling a common understanding of critical parameters for the
unbiased collection, storage, and optimal use of genomic samples
and data.
• This guideline also intends to increase awareness and provide a
reminder regarding subjects’ privacy, protection of the data
generated, the need to obtain suitable informed consent, and the
need to consider transparency of findings.
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REFERENCE
 International Journal of Pharmacy and Biological Sciences ICH
guidelines- E series; A review by K Bhavyasri, R Sai Chandana, M
Sumakant and D Rambabu.
 Textbook of Herbal Drug Technology by SS Agarwal and Paridhavi
2nd edition, Page no: 464 – 467.

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1

ICH GUIDELINES FOR QUALITY

EFFICACY GUIDELINES – ( E SERIES )

 These guidelines is concerned with the design, conduct,

E1 – Clinical safety for drugs intended for long term treatment

Phases of clinical trials

 Phase1 trials - In this researchers test an experimental drug or treatment in a small

Phase 3 trials- The experimental study drug or treatment is given to large

E2C (R1) - Clinical safety data management: periodic safety

E4 – Dose response information to support drug registration

E7- Studies in support of special populations: geriatrics

E10 – Choice of control group and related issues in clinical trials

• This guideline describes the general principles involved in choosing a control

E14 – Clinical evaluation for non Antiarrhythmic potential

E16 –Qualification of genomic biomarkers

• With the increasing globalization of drug development, it has become

E18 – Genomic sampling and the management of genomic data

• This guideline will facilitate the implementation of genomic studies by

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