The document discusses the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It summarizes that ICH is unique in bringing together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration and develop harmonized guidelines. ICH aims to harmonize technical requirements for pharmaceutical registration globally to help ensure safe, effective and high-quality medicines are developed and registered efficiently. It outlines ICH's structure and processes for developing guidelines through working groups and regulatory and industry members.

1. ICH
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
formerly
International Conference on Harmonisation (ICH) of Technical Requirements for the registration of Pharmaceuticals for Human Use
By
E. Gireesh Kumar
Associate Professor
Annamacharya College of Pharmacy, Rajampet

2. ICH
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
pharmaceuticals registration and develop
ICH guidelines.

3. ICH
• Unique harmonisation initiative for
regulators and pharmaceutical industry
• Originally founded in 1990
• Reformed as a non-profit legal entity
under Swiss Law on 23 October 2015

4. MISSION
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.

5. Purpose of ICH
Promotion of public health through international harmonisation that contributes to:
• Prevention of unnecessary duplication of clinical trials and post market clinical
evaluations
• Development and manufacturing of new medicines
• Registration and supervision of new medicines
• Reduction of unnecessary animal testing without compromising safety and
effectiveness
Accomplished through Technical Guidelines that are implemented by the regulatory
authorities.

6. Since its announcement of organisational changes in October
2015, ICH has grown as an organisation and now includes
17 Members and 32 Observers.
ICH - Overview
Since its inception in 1990, ICH has gradually evolved, to respond
to increasingly global developments in the pharmaceutical sector
and these ICH guidelines are applied by a growing number of
regulatory authorities.

7. Members and Observers
17 Members:
● Founding Regulatory: EC, Europe; MHLW/PMDA, Japan; FDA, United States
● Founding Industry: EFPIA; JPMA; PhRMA
● Standing Regulatory: Swissmedic, Switzerland; Health Canada, Canada
● Regulatory: ANVISA, Brazil; NMPA, China; HSA, Singapore; MFDS, Republic of
Korea; TFDA, Chinese Taipei; TITCK, Turkey
● Industry: BIO; Global Self-Care Federation; IGBA
2 Standing Observers: WHO; IFPMA
32 Observers: Regulatory authorities; Regional Harmonisation Initiatives;
international industry pharmaceutical organisations; international
organisations regulated or affected by ICH Guidelines

8. ICH Successes
Clinical trials conducted in one
ICH region can be used in
other ICH regions by setting
the common standards on
science and ethics.
CTD brings together all Quality,
Safety and Efficacy information
in a common, harmonised
format, accepted by regulators
in all ICH regions.
It has revolutionised regulatory
review processes for regulators and
industry.
(Medical Dictionary for Regulatory Activities)
Highly specific, standardised
medical terminology
developed by ICH to facilitate
sharing of regulatory
information.
It is used for registration,
documentation and safety
monitoring of medical products
GCP
CTD/
eCTD
MedDRA
(Common Technical Document)
(Good Clinical Practice)

9. Structure of the ICH Association

10. Members and Observers
● Remit of the Assembly and the Management Committee
● Assembly is: The overarching body of the Association, composed of all
Members that take decisions, regarding Articles of Association, Rules of
Procedures, admission of new Members, Adoption of ICH Guidelines, etc.
● Management Committee is: The body that oversees operational aspects of
the Association on behalf of all Members, including administrative and
financial matters and oversight of the WGs.
● Decision-making for ICH Guidelines
● The Management Committee provides: Recommendations on the selection
of new topics for harmonisation as well as on the adoption, withdrawal or
amendments of ICH Guidelines
● The Assembly takes decisions:
○ By consensus
○ In the absence of consensus: vote in accordance with the Articles of
Association, where only regulatory members have the right to vote

11. Steps in the ICH Process
for Guideline Development

12. Steps in the ICH Process
for Guideline Development
● Step 1: The WG works to prepare a consensus draft of the technical document.
● Step 2:
○ Step 2a: The Members of the ICH Assembly are invited to endorse the technical
document.
○ Step 2b: The Regulatory Members of the ICH Assembly are invited to endorse
the draft Guideline
● Step 3: Public consultation by the ICH Regulatory Members and ICH Secretariat. All
comments are considered by the WG.
● Step 3 is finalised once consensus is reached by the regulatory experts of the WG.
● Step 4: The Regulatory Members of the ICH Assembly adopt the final ICH harmonised
Guideline.
● Step 5: Implementation by the ICH Regulatory Members.

13. ICH Products
• Close to 70 Guidelines on technical requirements on:
• Safety–15 Guidelines
• Quality-24 Guidelines
• Efficacy–21 Guidelines
• Multidisciplinary-7 Guidelines
• Electronic Standards for the Transfer of Regulatory Information (ESTRI)
• CTD/eCTD
• MedDRA (standardised medical terminology)

14. Quality Guidelines
Harmonisation 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.
● Q1A - Q1F Stability
● Q2 Analytical Validation
● Q3A - Q3E Impurities
● Q4 - Q4B Pharmacopoeias
● Q5A - Q5E Quality of Biotechnological Products
● Q6A- Q6B Specifications
● Q7 Good Manufacturing Practice
● Q8 Pharmaceutical Development
● Q9 Quality Risk Management
● Q10 Pharmaceutical Quality System
● Q11 Development and Manufacture of Drug Substances
● Q12 Life Cycle Management
● Q13 Continuous Manufacturing of Drug Substances and Drug Products.
● Q14 Analytical Procedure Development, and revision of Q2(R1) Analytical Validation

15. Safety Guidelines
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.
● 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 Photosafety Evaluation
● S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicine
● S12 Nonclinical Biodistribution Studies for Gene Therapy Products

16. Efficacy Guidelines
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.
● E1 Clinical Safety for Drugs used in Long-Term Treatment
● E2A - E2F Pharmacovigilance
● E3 Clinical Study Reports
● E4 Dose-Response Studies
● E5 Ethnic Factors
● E6 Good Clinical Practice
● E7 Clinical Trials Geriatric Population
● E8 General Considerations for Clinical Trials
● E9 Statistical Principles for Clinical Trials
● E10 Choice of Control Group in Clinical Trials
● E11 - E11A Clinical Trials for Pediatric Population
● E12 Clinical Evaluation by Therapeutic Category
● E14 Clinical Evaluation of QT

17. Efficacy Guidelines
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.
● E15 Definitions in Pharmacogenetics / Pharmacogenomics
● E16 Qualification of Genomic Biomarkers
● E17 Multiregional Clinical Trials
● E18 Genomic Sampling
● E19 Safety Data Collection
● E20 Adaptive Clinical Trials

18. Multidisciplinary Guidelines
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).
● M1 MedDRA Terminology
● M2 Electronic Standards for the Transfer of Regulatory Information (ESTRI)
● M3 Nonclinical Safety Studies
● M4 Common Technical Document
● M5 Data Elements and Standards for Drug Dictionaries
● M6 Gene Therapy
● M7 Mutagenic Impurities
● M8 Electronic Common Technical Document (eCTD)
● M9 Biopharmaceutics Classification System (BCS)-based Biowaivers
● M10 Bioanalytical Method Validation
● M11 Clinical electronic Structured Harmonised Protocol
● M12 Drug Interaction Studies
● M13 Bioequivalence for Immediate-Release Solid Oral Dosage Forms

19. ICH
ICH has achieved international
harmonisation of technical guidelines, with
engagement of regulators and industry.
ICH engaged in Promotion of public health
through international harmonisation

20. THANK YOU