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Nivedita ICH GUIDELINES
1.
2. WHAT IS ICH
• Technical Requirements for Registration of
Pharmaceuticals for Human Use”
• ICH is a joint initiative involving both regulators and
research- based industry representatives of the EU, Japan
and the US in scientific and technical discussions of the
testing procedures required to assess and ensure the
safety, quality and efficacy of medicines
ICH Guidelines
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ICH is the “International Conference on Harmonization of
3. ICH LOCATED
• The ICH Secretariat is based in Geneva. The
biennial meetings and conferences of the ICH
Steering Committee rotate between the EU, Japan,
and the USA.
4. To increase international harmonization of technical requirements
to ensure that safe, effective and high quality medicines are
developed.
To harmonize technical requirements for registration or marketing
approval.
To develop and register pharmaceuticals in the most efficient and
cost effective manner.
To promote public health.
To prevent unnecessary duplication of clinical trials on humans.
To minimize the use of animal testing without compromising
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OBJECTIVES OF
ICH
safety and effectiveness of drug.
ICH Guidelines
5. To promote international harmonization by bringing together
representatives from the three ICH regions (EU, Japan and USA)
To discuss and establish common guidelines.
To make information available on ICH, ICH activities and ICH
guidelines to any country or company that requests the information
To promote a mutual understanding of regional initiatives in order to
facilitate harmonization processes related to ICH guidelines
regionally and globally
To strengthen the capacity of drug regulatory authorities and industry
to utilize them.
GOAL OF ICH
ICH Guidelines
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6. ICH is comprised of representatives from six parties that represent
the regulatory bodies and research-based industry in the European
Union, Japan and the USA.
In Japan, the members are the Ministry of Health, Labour and
Welfare (MHLW), and the Japan Pharmaceutical Manufacturers
Association (JPMA).
In Europe, the members are the European Union (EU), and the
European Federation of Pharmaceutical Industries and Associations
(EFPIA).
In the USA, the members are the Food and Drug Administration
(FDA), and the Pharmaceutical Research and Manufacturers of
America (PhRMA).
Additional members include Observers from the World Health
Organization (WHO), European Free Trade Association (EFTA), and
Canada. The Observers represent non-ICH countries and regions.
MEMBERS OF ICH
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7. ICH
STRUCTURE
ICH Guidelines
The ICH structure consists of the ICH Steering Committee, ICH
Coordinators, ICH Secretariat and ICH Working Groups.
ICH Steering Committee
The Steering Committee is the body that governs the ICH, determines
the policies and procedures for ICH, selects topics for harmonization
and monitors the progress of harmonization initiatives. Each of the
six ICH parties has two seats on the ICH Steering Committee.
ICH Coordinators
The Coordinators are fundamental to the smooth running of the ICH
and are nominated by each of the six parties. An ICH Coordinator
acts as the main contact point with the ICH Secretariat.
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8. ICH
SECRETARIA
T
ICH Guidelines
The Secretariat is primarily concerned with preparations for, and
documentation of, meetings of the Steering Committee as well as
coordination of preparations for Working Group and Discussion Group
meetings. Information on ICH Guidelines and the general ICH process
can be obtained from the ICH Secretariat.
ICH Working Group
Depending on the type of harmonization activity needed, the Steering
Committee will endorse the establishment of one of three types of
working group i.e., Expert Working Group (EWG), Implementation
Working Group (IWG) or Informal Working Group.
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9. the ICH
from the ICH Secretariat and
Steering Committee with
ICH
ICH OPERATES THROUGH ADMINISTRATIVE
SUPPORT COORDINATORS.
ICH Guidelines
The Steering Committee meets at least twice a year .
During these meetings, new topics will be considered for adoption,
reports are received on the progress of existing topics, and
maintenance and implementation of the guidelines are discussed.
The topics identified for harmonization by the Steering Committee
are selected from Safety, Quality, Efficacy, and Multidisciplinary
matters.
ICH OPERATION
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10. Step-1: Drafts are prepared and circulated through many revisions
until a "final harmonized draft" is completed
Step-2: This draft is signed by the EWG as the agreed-upon draft and
forwarded to the Steering Committee for signing which signifies
acceptance for consultation by each of the six co-sponsors
Step-3: The three regulatory sponsors initiate their normal consultation
process to receive comments.
STEPS IN THE
ICH PROCESS
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11. • Step-4 is reached when the Steering Committee agrees that there
is sufficient scientific consensus on the technical issues. This
endorsement is based on the signatures from the three regulatory
parties to ICH affirming that the Guideline is recommended for
adoption by the regulatory bodies of the three regions.
• Step-5: The
incorporated
process is complete
into national
when the guidelines are
or regional internal
procedures(implementation in the 3 ICH regions.)
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ICH Guidelines
13. • "Quality" Topics
CHEMICAL AND TESTING, IMPURITY
ICH Guidelines 13
i.e.,
Quality
those relating to
Assurance (Stability
pharmaceutical
Testing, etc.)
• Efficacy" Topics, i.e., those relating to clinical studies in human
subject (Dose Response Studies, Good Clinical Practices, etc.)
• Safety" Topics, i.e., those relating to in vitro and in vivo pre-
clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.)
• Multidisciplinary" Topics, i.e., cross-cutting Topics which do not
fit uniquely into one of the above categories.
15. Studies of
S1A: Guideline on the Need for Carcinogenicity
Pharmaceuticals
Carcinogenicity studies should be performed for any
pharmaceutical whose expected clinical use is continuous for at
least 6 months.
circumstances under which
This document provides a consistent definition of the
it is necessary to undertake
carcinogenicity studies on new drugs. These recommendations
take into account the known risk factors as well as the intended
indications and duration of exposure.
CARCINOGENICITY
STUDIES(S1A- S1C)
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16. THE OBJECTIVES OF CARCINOGENICITY STUDIES ARE TO
IDENTIFY A TUMORIGENIC POTENTIAL IN ANIMALS AND TO
ASSESS THE RELEVANT RISK IN HUMANS.
ICH Guidelines 16
S1B: Testing for Carcinogenicity of Pharmaceuticals
This document provides guidance on the need to carry out
carcinogenicity studies in both mice and rats, and guidance is also
given on alternative testing procedures which may be applied
without jeopardizing safety.
S1C(R2): Dose Selection for Carcinogenicity Studies of
Pharmaceuticals
This document addresses the criteria for the selection of the high
dose to be used in carcinogenicity studies on new therapeutic
agents to harmonize current practices and improve the design of
studies.
17. S2(R1): Guidance on Genotoxicity Testing and Data Interpretation
for Pharmaceuticals Intended for Human Use
• This guidance is a combination of ICH S2A and S2B guidelines:
S2A: Guidance on Specific Aspects of Regulatory Genotoxicity
Tests for Pharmaceuticals;
• This document provided specific guidance and recommendations for
in vitro and in vivo tests and on the evaluation of test results. It
includes terms related to genotoxicity tests to improve consistency in
applications.
S2
GENOTOXICIT
Y:
ICH Guidelines 17
18. r
• S2B: A Standard Battery for Genotoxicity Testing fo
Pharmaceuticals :
This document addresses two fundamental areas of genotoxicity
testing:
1.the identification of a standard set of assays to be conducted for
registration, and the extent of confirmatory experimentation in any
particular genotoxicity assay in the standard battery.
2.Registration of pharmaceuticals requires a comprehensive
assessment of their genotoxic potential. It is clear that no single test
is capable of detecting all relevant genotoxic agents. Therefore, the
usual approach should be to carry out a battery of in vitro and in vivo
tests for genotoxicity
ICH Guidelines 18
19. The purpose of this guideline is to optimize the standard genetic
toxicology battery for prediction of potential human risks, and for
interpretation of results, with the ultimate goal of improving risk
characterization for carcinogenic effects that have their basis in
changes in the genetic material.
ICH Guidelines 19
20. • S3A: Note for Guidance on Toxicokinetics: The Assessment of
Systemic Exposure in Toxicity Studies
• ICH guidelines do not require toxicokinetic studies to be conducted,
except in pregnant, lactating animals, before initiating reproductive
•
studies.
In this context, toxicokinetics is defined as the generation of
pharmacokinetic data, either as an integral component in the conduct
of non-clinical toxicity studies or in specially designed supportive
studies, in order to assess systemic exposure.
S3A- S3B
ICH Guidelines 20
Toxicokinetics and Pharmacokinetics:
21. This document gives guidance on developing test strategies in
toxicokinetics and the need to integrate these pharmacokinetics into
toxicity testing, in order to aid in the interpretation of the toxicology
findings and and their relevance to clinical safety issues
The primary objective of toxicokinetics is: to describe the systemic
exposure achieved in animals and its relationship to dose level and
the time course of the toxicity study.
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22. S3B: PHARMACOKINETICS: GUIDANCE FOR REPEATED
DOSE TISSUE DISTRIBUTION STUDIES
ICH Guidelines 22
• Tissue distribution studies are essential in providing information on
distribution and accumulation of the compound and/or metabolites,
especially in relation to potential sites of action; this information may
be useful for designing toxicology and pharmacology studies and for
interpreting the results of these experiments.
• This document gives guidance, when the repeated dose tissue
distribution studies should be considered (i.e., when appropriate
data cannot be derived from other sources). It also gives
recommendations on the conduct of such studies
23. S4: Duration of Chronic Toxicity Testing in Animals (Rodent
and Non-Rodent Toxicity Testing)
The objective of this guidance is to set out the considerations that
apply to chronic toxicity testing in rodents and non rodents as part of
the safety evaluation of a medicinal product
• Rodents (a study of 6 months duration)
• Non-rodents (a study of nine months duration).
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24. • S5: Detection of Toxicity to Reproduction for Medicinal
Products & Toxicity to Male Fertility
• This document provides guidance on tests for reproductive toxicity.
• It defines the periods of treatment to be used in animals to better
reflect human exposure to medical products and allow more specific
identification of stages at risk.
• It should encourage the full assessment on the safety of chemicals
on the development of the offspring.
ICH Guidelines 24
25. • S6: Preclinical Safety Evaluation of Biotechnology-
Derived Pharmaceuticals
This document covers the pre-clinical safety testing
requirements for biotechnological products. It addresses
the use of animal models of disease, determination of when
genotoxicity assays and carcinogenicity studies should be
performed, and the impact of antibody formation on
duration of toxicology studies.
The primary goals of preclinical safety evaluation are:
1)to identify an initial safe dose and subsequent dose in
humans;
2)to identify potential target organs for toxicity and for the
study of whether such toxicity is reversible;
3) to identify safety parameters for clinical monitoring.
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26. • This guideline was developed to protect clinical trial participants and
patients receiving marketed products from potential adverse effects
of pharmaceuticals
• This document addresses the definition, objectives and scope of
safety pharmacology studies.
• It also addresses which studies are needed before initiation of
Phase 1 clinical studies as well as information needed for marketing.
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ICH Guidelines
S7A: SAFETY PHARMACOLOGY STUDIES FOR HUMAN
PHARMACEUTICALS
27. • This guideline describes a non-clinical testing strategy for assessing
the potential of a test substance to delay ventricular repolarization.
• This guideline includes information concerning non-clinical assays
and integrated risk assessments.
S7B : THE NONCLINICAL EVALUATION OF THE POTENTIAL FOR
DELAYED VENTRICULAR REPOLARIZATION (QT INTERVAL
PROLONGATION) BY HUMAN PHARMACEUTICALS
ICH Guidelines 27
28. • This guideline addresses the recommendations on nonclinical
testing for immunosuppressant.
• The guideline might also apply to drugs in which clinical signs of
immunosuppressant are observed during clinical trials and following
approval to market.
• The term immunotoxicity in this guideline will primarily refer to
immunosuppressant, i.e. a state of increased susceptibility to
infections or the development of tumors.
S8 : IMMUNOTOXICITY STUDIES FOR HUMAN
PHARMACEUTICALS
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29. • S9: Nonclinical Evaluation for Anticancer Pharmaceuticals
• This guideline provides information for pharmaceuticals that are only
intended to treat cancer in patients with late stage or advanced
disease regardless of the route of administration, including both
small molecule and biotechnology-derived pharmaceuticals.
• It describes the type and timing of nonclinical studies in relation to
the development of anticancer pharmaceuticals and references
other guidance as appropriate.
• This guideline aims to facilitate and accelerate the development of
anticancer pharmaceuticals and to protect patients from
unnecessary adverse effects, while avoiding unnecessary use of
animals and other resources
ICH Guidelines 29
30. These guideline applies to new APIs . New excipients clinical
formulations for dermal application and photodynamic therapy
products.
It is an integrated process that can involve an evaluation of
photochemical characteristics, data from non clinical studies and
human safety information.
The photo safety assessment aims to determine weather risk
minimization measures are warranted to prevent adverse events in
humans.
In-vitro assay for photo-toxicity is the 3T3 neutral red uptake assay.
in vivo for species selection irradiation sensitivity, heat tolerance,
performance of reference substance should be considered.
S10 GUIDELINES-PHOTO SAFETY EVALUATION OF
PHARMACEUTICALS
ICH Guidelines 30
31. S11-FOR NON CLINICAL SAFETY TESTING IN SUPPORT OF
DEVELOPMENT OF PRDIATRIC MEDICINES
ICH Guidelines 31
This guideline is needed to recommended standards for the
conditions under which non clinical juvenile animal testing is
considered informative and support pediatric clinical trails .
The expert working group (EWG) Will consist of two nonclinical
experts nominated by EU,EFPIA,FDA, PhRMA, MHLW, JPMA,
HEALTH Canada and Swiss medic. One member can also be
nominated by WHO Observer, as well as RHIs, DRAs/doH
32. • The ICH M3 (R2) Guideline state, the conduct of any juvenile animal
toxicity studies should be considered when pervious animal data and
human safety data ,including effects from other drugs of
pharmacological class, are judged to be sufficient to support
pediatric studies
ICH Guidelines 32
