This document provides an overview of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). It discusses ICH's mission to achieve greater harmonization in drug development and registration. The document then lists and briefly describes the various ICH guidelines related to quality, safety, efficacy, and multidisciplinary topics.

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SUPERVISISED BY-
DR.DHARMENDRA JAIN
MRS.NISHI MODI
PRESENTED BY-
GAURAV RAJ SONI
M.PHARMA 2ND SEM
DEPARTMENT OF PHARMACEUTICAL SCIENCES
DR.HARISINGH GAUR VISHWAVIDYALAYA
SAGAR (M.P.)

2. ICH
INTERNATIONAL CONFERENCE ON
HARMONIS/ZATION of Technical
Requirements for the Registration of
Pharmaceuticals for Human
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3. The International Conference on Harmonisation of
Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH) is unique in
bringing together the regulatory authorities and
pharmaceutical industry of Europe, Japan and the US to
discuss scientific and technical aspects of drug
registration. Since 1990, ICH has evolved, through its
ICH Global Cooperation Group, to respond to the
increasingly global face of drug development, so that
the benefits of international harmonisation for better
global health can be realised worldwide. ICH's mission
is to achieve greater harmonisation to ensure that safe,
effective, and high quality medicines are developed and
registered in the most resource- efficient manner.
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GUIDELINES

5. QUALITY
“Harmonization achievements in the Quality
area include pivotal milestones such as the
conduct of stability studies, defining relevant
thresholds for impurities testing and a more
flexible approach to pharmaceutical quality
based on Good Manufacturing Practice (GMP)
risk management.”
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6. Q1: STABILITY
Q2: ANALYTICAL VALIDATION[Text and Methodology]
Q3: IMPURITIES
Q4: PHARMACOPOEIA
Q5: QUALITY OF BIOTECHNOLOGICAL PRODUCTS
Q6: SPECIFICATIONS
Q7: GOOD MANUFACTURING PRACTICES [Guide for
Active Pharmaceutical Ingredients]
Q8(R2): PHARMACETICAL DEVELOPMENT
Q9: QUALITY RISK MANAGEMENT
Q10: PHARMACEUTICAL QUALITY SYSTEM
Q11: DEVELOPMENT & MANUFACTURE OF DRUG
SUBSTANCES
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QUALITY

7.  Q1A: Stability Testing of New Drug
Substances and Products
 Q1B:Stability Testing : Photo stability Testing of
New Drug Substances and Products
 Q1C: Stability Testing for New Dosage Forms
 Q1D: Bracketing and Matrixing Designs for
Stability Testing of New Drug Substances and
Products
 Q1E: Evaluation of Stability Data
 Q1F: Stability Data Package for Registration
Applications in Climatic Zones III and IV
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8.  Q3A: Impurities in New Drug Substances
 Q3B: Impurities in New Drug Products
 Q3C: Impurities: Guideline for Residual
Solvents
 Q3D: Impurities: Guideline for Elemental
Impurities
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9.  Q4A: Pharmacopoeial Harmonization
 Q4B: Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the ICH
Regions
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10.  Q5A(R1): Viral Safety Evaluation of Biotechnology
Products Derived from Cell Lines of Human or Animal
Origin
 Q5B: Analysis of the Expression Construct in CellsUsed for
Production of r-DNA Derived Protein Products
 Q5C: Stability Testing of
Biotechnological/Biological Products
 Q5D: Derivation and Characterization of Cell
Substrates Used for Production of
Biotechnological/Biological Products
 Q5E: Comparability of Biotechnological/ Biological
Products Subject to Changes in their Manufacturing
Process
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11.  Q6A: Specifications : Test Procedures and
Acceptance Criteria for New Drug Substances
and New Drug Products: Chemical Substances
 Q6B: Specifications : Test Procedures and
Acceptance Criteria for
Biotechnological/Biological Products
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12. SAFETY
“ICH has produced a comprehensive set of safety
Guidelines to uncover potential risks like
carcinogenicity, genotoxicity and reprotoxicity. A
recent breakthrough has been a non-clinical testing
strategy for assessing the QT interval prolongation
liability: the single most important cause of drug
withdrawals in recent years.”
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13.  S1A - S1C Carcinogenicity Studies
 S2 Genotoxicity Studies
 S3A – S3B Toxicokinetics and Pharmacokinetics
 S4 Toxicity Testing
 S5 Reproductive Toxicology
 S6 Biotechnological Products
 S7A - S7B Pharmacology Studies
 S8 Immunotoxicology Studies
 S9 Nonclinical Evaluation for anticancer
Pharmaceuticals
 S10 Photo safety Evaluation
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SAFETY

14.  S1A: Need for Carcinogenicity Studies of
Pharmaceuticals
 S1B: Testing for Carcinogenicity of
Pharmaceuticals
 S1C: Dose Selection for CarcinogenicityStudies
of Pharmaceuticals
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15.  S3A: Note for Guidance on Toxicokinetics:
The Assessment of Systemic Exposure in
Toxicity Studies
 S3B: Pharmacokinetics: Guidance for
Repeated Dose Tissue Distribution Studies
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16.  S7A: Safety Pharmacology Studies for Human
Pharmaceuticals
 S7B: The Non-Clinical Evaluation of the
Potential for Delayed Ventricular
Repolarization (QT Interval Prolongation) by
Human Pharmaceuticals
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17. EFFICACY
“The work carried out by ICH under the Efficacy
heading is concerned with the design, conduct,
safety and reporting of clinical trials. It also covers
novel types of medicines derived from
biotechnological processes and the use of
pharmacogenetics/genomics techniques to produce
better targeted medicines.”
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18.  E1 - E2F Clinical Safety
 E3 Clinical Study Reports
 E4 Dose-Response Studies
 E5 Ethnic Factors
 E6 Good Clinical Practice
 E7 - E11 Clinical Trials
 E12 Clinical Evaluation by Therapeutic Category
 E14 Clinical Evaluation
 E15 - E16 Pharmacogenomics
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EFFCACY

19.  E1: The Extent of Population Exposure to Assess Clinical Safety
for Drugs Intended for Long-Term Treatment of Non- Life
Threatening Conditions
 E2A: Clinical Safety Data Management: Definitions and
Standards for Expedited Reporting
 E2B: Clinical Safety Data Management: Data Elements for
Transmission of Individual Case Safety Reports
 E2B:Implementation: Electronic Transmission of
Individual Case Safety Reports
 E2C: Periodic Benefit-Risk Evaluation Report
 E2C:Questions & Answers: PeriodicBenefit-Risk Evaluation
Report
 E2D: Post-Approval Safety Data Management: Definitions
and Standards for Expedited Reporting
 E2E: Pharmacovigilance Planning
 E2F: Development Safety Update Report
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20.  E7: Studies in Support of Special Populations:
Geriatrics
 E7 Q&As:Questions & Answers: Studies in
Support of Special Populations : Geriatrics
 E8: General Considerations for Clinical Trials
 E9: Statistical Principles for Clinical Trials
 E10: Choice of Control Group and Related
Issues in Clinical Trials
 E11: Clinical Investigation of Medicinal
Products in the Pediatric Population
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21.  E15: Definitions for Genomic Biomarkers,
Pharmacogenomics, Pharmacogenetics,
Genomic Data and Sample Coding Categories
 E16: Biomarkers Related to Drug or
Biotechnology Product Development:
Context, Structure and Format of
Qualification Submissions
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22. MULTIDISCIPLINARY
“Those are the cross-cutting topics which do not fit
uniquely into one of the Quality, Safety and
Efficacy categories. It includes the ICH medical
terminology (MedDRA), the Common Technical
Document (CTD) and the development of
Electronic Standards for the Transfer of Regulatory
Information (ESTRI).”
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23.  M1 MedDRA Terminology
 M2 Electronic Standards
 M3 Safety Studies
 M4 Common Technical Document
 M5 Data Elements and Standards for Drug
Dictionaries
 M6 Gene Therapy
 M7Genotoxic Impurities
 M8 Electronic Common Technical Document
(eCTD)
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MULTIDISCIPLINARY

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