2. CONTENTS
• WHAT IS ICH
• IMPACT OF ICH
• OBJECTIVES
• STRUCTURE OR ORGANIZATION
• GUIDELINES
• REFERENCES
3. WHAT IS ICH?
• The term ICH is international conference on
hormonisation of technical requirements for
registration of pharmaceuticals for human
use.
• The ICH was born in april 1990 in a meeting
hosted by EFPIA in Brussels.
• The meeting was attended by representatives
from Japan, u.s , European union.
4. .
• This meeting was mainly to harmonize several
processes and the actions that are performed
during the development process of a drug.
• Harmonization has several benefits in
promoting public health as it helps to avoid or
eliminate the need for unnecessary repetition
of clinical trials in humans, minimizes the need
for animal testing without compromising on
the safety and efficacy of the drug.
• It also reduces the time and resources
required for the new drug development.
5. IMPACT OF ICH
• Enhanced patient safety
• Streamline development programs
• Common quality standards
• Reduce resource requirements
• Forum for communication
• Discuss drug development procedure with a
common goal of identifying best scientific
practice & applying the same uniformity
across the globe
6. OBJECTIVES
• 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 developed and registered pharmaceuticals
in the most efficient and cost effective
manner.
7. Contd…
• To promote public health
• To prevent unnecessary duplication of clinical
trials on humans.
• To minimize the use of animal testing without
compromising safety and effectiveness of
drug.
8. STRUCTURE OR ORGANIZATION
• Steering Committee:
• The ICH Steering Committee (SC) is the governing
body that oversees the harmonization activities.
Since its establishment in 1990, each of its six co-sponsors
(EU, EFPIA, MHLW, JPMA, FDA, PhRMA )
• Other parties have a significant interest in ICH
and have been invited to nominate Observers to
the SC.
9. .
• The three Observers are the World Health
Organization (WHO), Health Canada(HC) and
the European Free Trade Association (EFTA).
10. The ICH receives support from the
following organizations:
• European commission(EC)
• European federation of pharmaceutical industries
and association(EFPIA)
• Ministry of health, labour and welfare(MHLW)
• Japan pharmaceutical manufacturers
association(JPMA)
• Food and drug administration(FDA)
• Pharmaceutical research and manufacturers of
America(Ph RMA)
• World Health Organization (WHO)
11. EC/European commission :
• The European Commission represents the 27
members of the EU .
• The Commission works through
harmonization of legislation and technical
requirements and procedures, to achieve a
single market in pharmaceuticals to allow free
movement of products throughout the EU.
12. EFPIA :
• EFPIA is situated in Brussels and has, as its
members, 31 national pharmaceutical
industry associations and 40 leading
pharmaceutical companies involved in the
research, development and manufacturing of
medicinal products in Europe for human use.
• Much of the Federation's work is concerned
with the activities of the European
Commission and the European Medicines
Agency
13. MHLW :
• Ministry of Health, Labour and Welfare is a
Technical and scientific support for ICH
activities are provided by the Pharmaceuticals
and Medical Devices Agency (Ph MDA) and by
the National Institute of Health Sciences
(NIHS) and others
14. JPMA :
• Japan Pharmaceutical Manufacturers
Association (JPMA) ICH work is coordinated
through the specialized committee of experts
from JPMA companies.
15. FDA / US Food and Drug
Administration :
• The US Food and Drug Administration (FDA)
has a wide range of responsibilities for drugs,
biological , medical devices, cosmetics and
radiological products.
• The largest of the world's drug regulatory
agencies FDA is responsible for the approval of
all drug products used in the US
16. PhRMA :
• The Pharmaceutical Research and Manufacturers
of America - PhRMA - represents the research-based
industry in the USA.
• The Association has 67 companies in
membership which are involved in the discovery,
development and manufacture of prescription
medicines.
• There are also 24 research affiliates which
conduct biological research related to the
development of drugs and vaccines
17. Secretariat :
• The ICH Secretariat is located in Geneva,
Switzerland. Its staff is responsible for day-to-day
management of ICH, namely preparations
for, and documentation of, meetings of the
Steering Committee and its Working Groups.
• The ICH Secretariat also provides
administrative support for the ICH Global
Coordination Group and the ICH MedDRA
Management Board
18. Coordinators :
• Coordinators ensure proper distribution of ICH
documents to the appropriate persons from
their party (SC members, Topic Leaders,
Experts) and are responsible for proper follow
up on actions by their respective party within
assigned deadlines.
19. Working groups :
• There are several different types of ICH
working groups that can be
• EWG: (Expert Working Group) is charged with
developing a harmonized guideline that meets
the objectives in the Concept Paper and
Business Plan.
• IWG: (Implementation Working Group) is
tasked to develop Q&As to facilitate
implementation of existing guideline
20. GUIDELINES
• Safety (S)
• Dealing with in vitro & in vivo pre clinical testing
• Quality (Q)
• Chemical & Pharmaceutical QA
• Stability, Specifications, Analytical
• Efficacy (E)
• Clinical studies in humans
• Multidisciplinary (M)
• Terminology
• Electronic standards
• Common Technical Documents
22. Carcinogenicity Studies
S1A Need for Carcinogenicity Studies of
Pharmaceuticals
S1B Testing for Carcinogenicity of
Pharmaceuticals
S1C(R2) New title: Dose Selection for Carcinogenicity
Studies of Pharmaceuticals & Limit Dose
23. Genotoxicity Studies
S2(R1) Guidance on genotoxicity testing & data
interpretation of pharmaceuticals intended
for human use.
S2A Guidance on Specific Aspects of Regulatory
Genotoxicity Tests for Pharmaceuticals
S2B Genotoxicity : A Standard Battery for
Genotoxicity Testing of Pharmaceuticals
24. Toxico kinetics and Pharmacokinetics
S3A Note for Guidance on Toxicokinetics : The
Assessment of Systemic Exposure in Toxicity
Studies
S3B Pharmacokinetics: Guidance for Repeated
Dose Tissue Distribution Studies
25. Toxicity Testing
S4 Duration of Chronic Toxicity Testing in
Animals (Rodent and Non Rodent Toxicity
Testing)
S5(R2) New title: Detection of Toxicity to
Reproduction for Medicinal Products &
Toxicity to Male Fertility
S6 Preclinical Safety Evaluation of
Biotechnology-Derived Pharmaceuticals
26. Pharmacology Studies
S7A Safety Pharmacology Studies for Human
Pharmaceuticals
S7B The Non-Clinical Evaluation of the Potential for
Delayed Ventricular Repolarization by Human
Pharmaceuticals
S8 Immuno toxicity Studies for Human
Pharmaceuticals
S9 Non-Clinical evaluation for anticancer
Pharmaceuticals
27. Quality Guidelines
• Stability
• Analytical Validation
• Impurities
• Pharmacopoeias
• Quality of Biotechnological Products
• Specifications
• Good Manufacturing Practice
• Pharmaceutical Development
• Quality Risk Management
28. Stability
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
29. Q1E Evaluation of Stability Data
Q1F Stability Data Package for
Registration Applications in
Climatic Zones III and IV
30. IMPURITIES
Q3A(R2) Impurities in New Drug Substances
Q3B(R2) Impurities in New Drug Products
Q3C(R2) Impurities: Guideline for Residual
Solvents Impurities
32. Quality of Biotechnological Products
Q5A Viral Safety Evaluation of Biotechnology
Products Derived from Cell Lines of Human
or Animal Origin
Q5B Quality of Biotechnological Products : Analysis of the
Expression Construct in Cells Used for Production of
r-DNA Derived Protein Products
Q5C Quality of Biotechnological Products :
Stability Testing of
Biotechnological/Biological Products
33. Specifications
Q6A Specifications : Test Procedures and Acceptance
Criteria for New Drug Substances and New Drug
Products: Chemical Substances (including
Decision Trees)
Q6B Specifications : Test Procedures and
Acceptance Criteria for
Biotechnological/Biological Products
Q7 Good Manufacturing Practice Guide for
Active Pharmaceutical Ingredients
35. Efficacy guidelines (Clinical studies)
• Clinical Safety
• Clinical Study Reports
• Dose-Response Studies
• Good Clinical Practice
• Clinical Trials on special population
• Guidelines for Clinical Evaluation by Therapeutic
Category
• Clinical Evaluation-( statistical consideration)
• Pharmacogenomics
36. Clinical Safety
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
37. E2C Clinical Safety Data Management:
Periodic Safety Update Reports for
Marketed Drugs
E2D Post-Approval Safety Data
Management: Definitions and Standards
for Expedited Reporting
E2E Pharmacovigilance Planning
38. E3 Structure and Content of Clinical
Study Reports
E4 Dose-Response Information to
Support Drug Registration
E5 Ethnic Factors in the Acceptability of
Foreign Clinical Data
E6 Good Clinical Practice
39. Clinical Trials
E7 Studies in Support of Special Populations:
Geriatrics
E8 General Consideration of 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
40. E12 Principles for Clinical Evaluation of
New Antihypertensive Drugs
E14 The Clinical Evaluation of QT/ QTc Interval
Prolongation and Proarrhythmic Potential
for Non- Ant arrhythmic Drugs
E15 Terminology in Pharmacogenomics
E16 Genomic Biomarkers related to Drug
Response
41. Multidisciplinary Guidelines
M1 Medical Terminology (MedDRA)
M2 Electronic Standards for Transmission of
Regulatory Information (ESTRI)
M3 Timing of Pre-clinical Studies in Relation to
Clinical Trials
M4 The Common Technical Document (CTD)
M5 Data Elements and Standards for Drug
Dictionaries 23
