The International Conference on Harmonization (ICH) was established in 1990 by a committee representing the pharmaceutical industry and regulatory agencies. The ICH aims to improve new drug development and registration through harmonized guidelines. It involves regulators and industry from the US, EU, and Japan. The ICH structure includes a Steering Committee, Secretariat, and working groups that meet twice yearly to develop guidelines on quality, safety, efficacy, and multidisciplinary topics.

1. INTERNATIONAL
CONFERENCE ON
HARMONIZATION
Mr. P. B. Jadhav
HOD. Department of Quality Assurance

2. At the 1990 International Conference on Harmonization (ICH)
of Technical Requirements for Registration of Pharmaceuticals
for Human Use, a committee of representatives from industry
and regulatory agencies was established.
International Conference on Harmonization
Mr. P. B. Jadhav

3.  Well-defined objective: to improve efficiency of new drug development
and registration process
 Accomplished through the development and implementation of harmonized
guidelines and standards
Unique harmonization project involving the Unique harmonization
project involving the regulators and research-based industries of US, EU
and Japan—started in 1990
Mr. P. B. Jadhav

4. Mr. P. B. Jadhav

5. Mr. P. B. Jadhav
Central Drugs Standard
Control Organization
(CDSCO), India

6. ICH Structure
Steering Committee
Decision-making
body
Secretariat
Quality Safety Efficacy
Working Groups
(development +
Implementation)
Steering Committee + Working Groups meet twice a year
Mr. P. B. Jadhav

7. STEERING COMMITTEE: The ICH Steering Committee (SC) is the governing body
that oversees the harmonization activities.
A)SECRETARIAT : The Secretariat 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.
Mr. P. B. Jadhav

8. Steps of ICH Harmonization
STEP 5--Implementing Guidelines in ICH Regions
STEP 4--Adopting Harmonized Guidelines
STEP 3--Consulting with Regional Regulatory Agencies—Comment Period
STEP 2--Agreeing on Draft Text
STEP 1--Building Scientific Consensus
Mr. P. B. Jadhav

9. - To develop international standards for
• Quality
• Safety
• Efficacy
- It promotes greater harmonization of technical guidelines and to establish
requirements for product registration that would prevent or reduce unnecessary
duplication of testing in the development of new products without compromising
safety and effectiveness.
- Additional goals were to increase cost efficiency, and- to minimize delays in
product development.
OBJECTIVES OF ICH
Mr. P. B. Jadhav

10. ICH Core Objectives
• Identification and elimination of the need to duplicate studies to meet
different regulatory requirements .
• More efficient use of resources (human, animal, material) in the R&D
process, as a consequence.
• Quicker access to patients of safe and effective new medicines .
Mr. P. B. Jadhav

11. This group’s work resulted in guidelines in four major categories:{ EXPERT WORKING
GROUPS}
Chemical and pharmaceutical quality assurance,
Safety in pre-clinical studies.
Efficacy of clinical studies, and
Multidisciplinary topics such as medical terminology and electronic standards for
transmission of regulatory documents.
The guidelines for each of these categories are identified by the letters
Q for quality, S for safety, E for efficacy, and M for multidisciplinary
Mr. P. B. Jadhav

12. QUALITY :
Harmonisation achievements in the Quality area include 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.
Mr. P. B. Jadhav

13. SAFETY:
ICH has produced a comprehensive set of safety Guidelines to
uncover potential risks like carcinogenicity, genotoxicity and
reproductive toxicity. 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.
Mr. P. B. Jadhav

14. EFFICACY:
It 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.
Mr. P. B. Jadhav

15. 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).
Mr. P. B. Jadhav

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20. Quality
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Thank You