ICH – GCP

Consolidated Guidelines
 Good Clinical Practice (GCP)
 An international ethical & scientific quality
standards for designing, conducting, monitoring,
auditing, recording, analysis and reporting of trials
that involve the participation of human subjects

 Provides assurance that the data and results are

credible, accurate and that the rights, integrity and
confidentiality of treial subjects are protected
 ICH – GCP : Evolution
1980s - EC
– Pioneered harmonization of regulatory requirements
– Develop single market for medicinal products
– Demonstrated feasibility of harmonization

• 1989, Paris - WHO Conference of Drug Regulatory Authorities

– IFPMA – discuss joint regulatory-industry initiative
– ICH conceived

• Apr, 1990, Brussels – EFPIA

– Birth of ICH
– ICH Steering Committee established
 Need to Harmonize
• Awareness on critical evaluation of medicinal products
• Medical tragedies
• 1960-70: rapid increase in laws, regulations & guidelines
on medicinal products
• Widening market opportunities for Pharma industry
• Duplication of work
• Raising cost of health care
• Timely Access of Patients to Safe & Effective “New
Drugs”
• Need to meet public expectation
 ICH – GCP: Objectives
Focus:
Technical requirements for medicinal products containing new
drugs.

Objectives:
To provide a unified standard for the European Union (EU),
Japan & United States to facilitate mutual acceptance of
clinical data by the authorities in these jurisdictions.
 ICH Administration
ICH parties : Steering committee(SC)
Observers

SC - Co-ordinators
Secreteriat
Expert Working Groups (EWGs)
 Structure of ICH - Parties
• Participants
Six Parties: EU, EFPIA, FDA,
MHLW, JPMA, PhRMA,
Three Observers: WHO, EFTA, Canada

1) European Commission - European Union (EU)

2) European Federation of Pharmaceutical Industries and Associations (EFPIA)
3) US Food and Drug Administration (FDA)
4) Ministry of Health, Labor and Welfare, Japan (MHLW)
5) Japan Pharmaceutical Manufacturers Association (JPMA)
6) Pharmaceutical Research and Manufacturers of America (PhRMA)
 Structure of ICH -
Administration

• Organization
SC: Policy Issues
EWG: Technical Guidelines

Major Conferences:
ICH 1 (’91) – ICH 5 (’00)
ICH 6 (Osaka, Japan, Nov. 2003)
 SC & EWG
• Steering Committee (SC)
– 2 members from each of the 6 co-sponsors
– Meets twice a year
– Operates within the Terms of Reference
– Determines policies & procedures
– Selects topics for harmonization
– Monitors progress of harmonization initiatives

• Expert Working Group (EWG)

– Appointed by SC for each topic
– Review difference in requirement between 3 regions
– Develop scientific consensus to bridge the gap
– Report to SC
 The Guidelines - QSEM
• Quality (Q)
- chemical & pharmaceutical QA
• Safety (S)
– dealing with in vitro & in vivo pre clinical testing
• Efficacy (E)
– clinical studies in human beings
• Multidisciplinary (M)
– Terminology
– Electronic Standards
– Common Documents
 Quality Guidelines
• Q 1: Stability - Photostability
• Q 2: Analytical Validation
• Q 3: Impurities
• Q 5: Biotechnological Quality
• Q 6: Specifications
• Q 7: GMP for active pharma ingredients
• Q 8: Pharmaceutical development
• Q 9: Quality risk management
 Safety guidelines
• Safety (S)
– S1: Carcinogenicity studies – Need, Testing, Dose
Selection
– S2: Genotoxicity – Regulatory, Battery of Tests
– S3A: Toxicokinetics
– S3B: Pharmacokinetics
– S4: Chronic Toxicity Testing
– S5A: Toxicity to Reproduction
– S5B: Toxicity to Male Fertility
– S6: Preclinical Biotech derived drugs
– S7A: Safety Pharmacology
– S7B: QT interval prolongation
– S8: Immunotoxicity
 Efficacy Guidelines(1)
– E 1: Exposure – to assess
clinical safety
– E 2: Clinical Safety Data
Management
(E2A, E2B, E2C)
– E 3: Study Reports
– E 4: Dose Response Studies
– E 5: Ethnic Factors
– E 6: Good Clinical Practice
(GCP)
 Efficacy Guidelines (2)
– E 7: Special Populations - Geriatrics
– E 8: Clinical Trials Design
– E 9: Statistical Considerations
– E 10: Choice of Control Group
– E 11: Special Populations – Children
– E 12: Therapeutic categories
(E 12A)
- E 14: The clinical evaluation of QT/QTc interval
prolongation and proarrhythmic potential for
non antiarrhythmic drugs
 The Multidisciplinary
Topics
• Multidisciplinary (M)
– M1: Medical Terminology
– M2: Electronic Standards for Transfer of
Regulatory Information & Data (ESTRI)
– M3: Maintenance of ICH guidelines for
nonclinical safety studies
– M4: Common Technical Document (CTD)
• M4Q: Quality
• M4S: Safety
• M4E: Efficacy
 ICH E6: Principles of GCP

GUIDELINE FOR
GOOD CLINICAL PRACTICE

ICH Harmonised Tripartite

Guideline
 ICH Information Brochure
Section I – ICH Past
Section II – ICH Structure
Section III – ICH SC & EWG
Section IV – ICH Harmonization Process
Section V – ICH Future
 ICH GCP - Non ICH
Regions
• Establishment of the Global Co-
operation Group (GCG), formed in
March 1999
• Purpose:– make information
available on ICH, ICH activities &
the guidelines
 The Impact of ICH
• Enhanced patient safety
• Streamline development programs
• Common quality standard
• Reduce resource requirements
• Forum for Communication
• Opportunity for Industry & Regulators
to sit across the table
– Discuss drug development procedure with a
common goal of identifying best scientific
practice and applying the same uniformly
across the globe
 ICH GCP - Updates
• The last ICH SC & EWG meeting was held
in Chicago, on 9th - 10th Nov, 2005
– 2 Guidelines adopted
• Q 8 – Pharmaceutical Development
• Q 9 – Quality Risk Management
– Potential topics discussed
• Biotechnology
• Pharmacogenomics
• Pharmacovigilance
• Gene Therapy
• Next ICH SC meeting – Yokohama,5th -8th Jun ’06
• ICH 7 conference – Vienna, March 2007
 ICH in future
• Timely Access of Innovations for Patients
globally
• Changing Environment – Regulations &
Sciences
• Maintenance & Implementation – CTD &
GLs
• Pharmacovigilance
• Transparency – Global Cooperation, Large
Conference
 GCP: Evolution
WHO
ICH

USFDA
EU

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