The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner. On 23 October 2015, ICH announced organisational changes as it marks 25 years of successful harmonisation.

1. D.R. CHANDRAVANSHI
ASSISTANT PROFESSOR (ADHOC)
SLT INSTITUTE OF PHARMACEUTICAL SCIENCES,
GURU GHASIDAS VISHWAVIDYALAYA BILASPUR C. G.
(A CENTRAL UNIVERSITY)

2. CONTENT
• Introduction
• Objectives
• Location of ICH
• ICH Members
• ICH Organization
• ICH Operation
• ICH Guidelines
2

3. INTRODUCTION
• Also known as “International Conference on Harmonization”
• ICH-international council for harmonization of technical requirements for pharmaceuticals for
human use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical
industry to discuss scientific and technical aspects of drug registration.
• Project, that brings together regulatory authorities of Europe, Japan & US, to discuss scientific &
technical aspects of pharmaceutical product registration.
• ICH’s mission is to achieve greater harmonization worldwide to ensure that safe, effective, and
high-quality medicines are developed and registered in the most resource-efficient manner.
• 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 manufacturing
practice (GMP) risk management. 3

4. OBJECTIVES
• Harmonization of legislative & technical requirements
• Mutual acceptance of data between Europe, Japan & US
• To reduce cost of research work duplications
• To reduce time-frame for global marketing of newer drugs after approval
• To maintain & formulate guidelines on quality, safety & efficacy-based regulations, for
consumer & patient benefits.
4

5. LOCATION OF ICH
• The ICH Secretariat is based in Geneva, Switzerland
• Biennial meetings & conferences of ICH Steering Committee shuffle between the European
Union, Japan & the US.
5

6. ICH MEMBERS
• ICH consists of representatives from 6 parties that represent the regulatory bodies & research-
based industry in the EU, Japan & the USA
• In Japan, the members include:
• Ministry of Health, Labour & Welfare (MHLW)
• Japan Pharmaceutical Manufacturers Association (JPMA)
• In Europe, the members include:
• European Union (EU)
• European Federation of Pharmaceutical Industries and Associations(EFPIA)
6

7. CONTI….
• In the USA, the members include:
• Food and Drug Administration (FDA)
• Pharmaceutical Research and Manufacturers of America (PhRMA)
• Additional members include:
• Observers from the WHO (represent non-ICH countries & regions)
• European Free Trade Association (EFTA)
• Canada
7

8. ICH ORGANIZATION
• ICH structure consists of:
• ICH steering committee
• ICH coordinators
• ICH Secretariat
• ICH Working Groups.
8

9. ICH OPERATION
• ICH operates through the Steering Committee, with administrative support from Secretariat
& Coordinators
• Steering committee meets at least twice a year
• During above meetings the following measures are adopted:
• Discussion of new topics for adoption
• Review of existing topics progress reports
• Discussion of maintenance & implementation of guidelines.
• • Topics identified for harmonization by Steering Committee selected from Safety, Efficacy,
Quality & Multidisciplinary matters.
9

10. STEPS IN THE ICH PROCESS
• There are 5 steps involved, They includes:
• A. STEP 1:
• - Drafts are prepared circulated through many revisions leads to assimilation of
• a “final harmonized draft”
• B. STEP 2:
• - Draft is signed by EWG forwarded to Steering Committee for signing
• signifies acceptance for consultation by each of the 6 co-sponsors
10

11. • C. STEP 3:
• - 3 regulatory sponsors initiate their normal consultation process to receive comments.
• D. STEP 4:
• -Reached, when the Steering Committee agrees that there is sufficient scientific consensus
on technical issues
• -This endorsement is based on signatures from the 3 regulatory parties to ICH, affirming that
the Guideline is recommended for adoption by the regulatory bodies of the 3 regions.
• E. STEP 5:
• - Guidelines incorporated into national/ regional internal procedures(implementation in the
3 ICH regions).
11

12. ICH GUIDELINES
• ICH guideline topics include:
• QUALITY
• SAFETY
• EFFICACY
• MULTIDISCIPLINARY.
12

13. QUALITY (Q)
• 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.
• Refer to topics related to chemical & pharmaceutical Quality Assurance examples include:
• Stability testing
• Impurity testing, etc
13

14. SAFETY (S)
• 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.
• Refers to topics, that deal with in-vitro & in-vivo pre-clinical studies examples include:
• Carcinogenicity testing
• Genotoxicity testing, etc.
14

15. EFFICACY (E)
• 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/ pharmacogenomics
techniques to produce better targeted medicines.
• Refers to topics, that deal with clinical studies in human subjects Include:
• Dose-Response studies
• Good Clinical Practices, etc.
15

16. MULTIDISCIPLINARY (M)
• 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).
• Refer to topics, that do not fit uniquely into any of the above categories. Hence also known as
“cross-cutting topics”
16

17. QUALITY GUIDELINES
17

18. Q1A-Q1F GUIDELINES:
Deals with:
• STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS:
• The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug
product varies with time under the influence of a variety of environmental factors such as temperature,
humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug
product.
• PHOTOSTABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS:
• Give guidance on the basic testing protocol required to evaluate the light sensitivity and stability of new
drugs and products.
• STABILITY TESTING FOR NEW DOSAGE FORMS:
• Gives guidelines for new formulations of already approved medicines
• Defines the circumstances under which reduced stability data can be accepted.
18

19. • EVALUATION OF STABILITY DATA:
• Addresses the evaluation of stability data that should be submitted in registration
applications for new molecular entities and associated drug products.
• Provides recommendations on establishing shelf lives for drug substances and drug
products intended for storage at or below “room temperature”.
19

20. Q2 GUIDELINES:
Deals with ANALYTICAL VALIDATIONS:
• VALIDATION OF ANALYTICAL PROCEDURES- TEXT AND METHODOLOGY:
• The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended
purpose
• Gives validation parameters needed for a variety of analytical methods
• Discusses the characteristics that must be considered during the validation of the analytical procedures.
• Types of Analytical Procedures to be validated include:
• Identification tests
• Quantitative tests for impurities content
• Limit tests for the control of impurities
• Quantitative tests of the active moiety in samples of drug substance or drug product or other selected
components in the drug product.
20

21. Q3A-Q3D GUIDELINES:
Deals with IMPURITIES
Include:
• IMPURITIES IN NEW DRUG SUBSTANCES:
• Guideline addresses the chemistry and safety aspects of impurities, including the listing of
impurities, threshold limit, identification and quantification
• Impurities are classified into 3:
i. Organic impurities (process- and drug-related)
ii. Inorganic impurities
iii. Residual solvents
21

22. • IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS :
• Examples include:
• Benzene - 2ppm
• CCl4- 4ppm
• Dichloromethane-5ppm
• Dichloroethane - 8ppm
• Acetonitrile- 410ppm
• Chloroform - 60ppm
• Chlorobenzene- 360ppm
22

23. REFERENCES
• EU Commission
• https://www.ich.org/
• https://european-union.europa.eu/index_en
23