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A Case Study in the Value of Harmonisation. Yoshikazu HAYASHI Deputy Director Evaluation and Licensing Division Pharmaceutical & Food Safety Bureau Ministry of Health, Labour and Welfare, JAPAN. Philosophy/Purpose of ICH.

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a case study in the value of harmonisation
A Case Study in the Value of Harmonisation

Yoshikazu HAYASHI

Deputy Director

Evaluation and Licensing Division

Pharmaceutical & Food Safety Bureau

Ministry of Health, Labour and Welfare, JAPAN

philosophy purpose of ich
Philosophy/Purpose of ICH
  • Eliminate Duplication in Tests to meet Different Regulatory Requirements
  • More Efficient Use of Resources
  • Timely Access of Patients to Safe and Effective “New Drugs”
structure of ich
Structure of ICH
  • ICH Participants

   Six Parties: EU, FDA, MHLW,


+ Observers: WHO, EFTA, Canada

  • Organization

   SC: Policy Issues

   EWG: Technical GLs

   Major Conferences:

   ICH 1 (’91) – ICH 5 (’00)

   ICH 6 (Osaka, Japan, Nov. 2003)

ich guidelines
ICH Guidelines
  • ICH is neither a forum of global politics nor a trade negotiation,
  • but a scientific forum
  • ICH covers “new drugs”
  • ICH guidelines provide “how to collect data scientifically for marketing authorization”
ich process for technical issues
ICH Process for Technical Issues

Step 1: Consensus Building/Drafting of GL

Step 2: SC Agrees to Releasing Draft GL

Step 3: Regulatory Consultation/

Consolidation of Comments

Step 4: Adoption of GL by Regulators/

Publishing ICH GL

Step 5: Regulatory Implementation

mode of implementation
Mode of Implementation

1. Formal Vehicles

  • Amending Existing GLs
  • Issuing New GLs
  • Law Amendment

2. Supplemental Vehicles

  • Q&A, Compendium in MHLW Notif.
  • Seminars, Publications by Private Sectors (Japan Pharmacopoeia, etc.)
12 year achievements of ich
12 Year Achievements of ICH
  • Understanding of Innovation
  • Common Regulatory Platform based on ca. 50 GLs (Q, S, E)
  • Improvement of Scientific GLs
  • Facilitating Communication Among Regulators & Between Regulators and Industries Toward the Common Goal
  • Effective Use of R&D Resources including Data Collected in Other Regions
achievement in ich phase i 1990 ich4 in 1997
Achievement in ICH Phase I(1990 – ICH4 in 1997)

1. About 40 ICH GLs (Q, S, E)

Substantially Completed

2. Scientific Basis for Testing and

Evaluation Harmonised

3. Major Causes of Redundancy/

Duplication Eliminated

ich phase ii activity future ich 4 1997
ICH Phase II Activity & Future(ICH 4 (1997) - )

1. Dealing More on Regulation

Common Technical Document (CTD)

ADR Report: MedDRA/Electronic Transfer

2. New GLs on Emerging Issues

3. Finalizing Uncompleted GLs/Maintaining Existing GLs

4. Globalization of ICH Activities

(e.g. GCG)

mhlw s implementation of ich gls july 2003
MHLW’s implementation of ICH GLs ( ~July. 2003)
  • Quality: Q1~7
  • Stability, Impurities, Quality of Biotech. Products, GMP for APIs, etc.
  • Safety: S1~7
  • Carcinogenicity, PK, Reprotox, etc.
  • Efficacy: E1~11
  • PSUR, Ethnic Factors, GCP, Pediatrics, etc.
  • Multidisciplinary: M1~4
  • MedDRA, CTD, eCTD, etc.
impact of ich regulator s view
Impact of ICH; Regulator’s View

1. General

  • Science-Based Discussion with Industry

and Other DRA Facilitated

2. Tests/Data for NDA

  • Quality of Tests/Data Improved
  • More Foreign Data Submitted

3. NDA Review

  • To Improve NDA Review
  • Review Reform
  • Collaboration among DRA
implementation of new gcp
Implementation of New GCP

1. Amended Regulations

  • PAL (’96), GCP Ordinance (’97)
  • Effective Step-by-Step, 100% in April ’98

2. “Hollowing Out” of Clinical Trials in Japan?

  • MHLW’s Role/Responsibility to Encourage CTs
  • Ethically Wrong to Depend on CTs Abroad?
  • Japan’s CTs Exposed to Global Competition (Cost, Quality, etc.)
acceptance of foreign clinical data
Acceptance of Foreign Clinical Data

1. MHLW’s Past Policy

  • Accept if GCP, Raw Data, Japan’s GL
  • PK, Dose-Finding, Ph3 DB on Japanese Population

2. New GL based on E5 & Expectation

  • Scientific Bridging Study
  • Consultation Encouraged on Completeness
data package for bridging study
Data-package for Bridging Study

Japanese data

Foreign data

PK/PD study

PK/PD study

Bridging study

Study for bridging

Comparative study

Long term study

Study on patients

with risk

Comparative study

Long term study

Study on patients

with risk

how ctd is implemented by mhlw
How CTD is implementedby MHLW


CTD Modules

NDA Application Form


+ other region specific information








Report Q

Report S

Report E

ctd will be facilitating
CTD will be facilitating
  • Harmonized Application Dossier (Content and Format)
  • Synchronized R&D Strategy
  • Synchronized NDA Submission to EU, US and Japan
  • NDA Review Cooperation
  • Synchronized Approval and Marketing
global cooperation group gcg
Global Cooperation Group (GCG)
  • Created in 1999 to make information available on ICH activities and GLs
  • Some principles
  • GCG Resource for information and data   reference
  • GCG will not seek to impose its views
  • GCG will provide information upon request from non-ICH countries
evolution of gcg
Evolution of GCG
  • Interaction with non-ICH Regional Harmonisation Initiatives (APEC, ASEAN, PAHO/PANDRH, SADC)
  • The Challenges are:
  • Varying Capacities Across A Region
  • The Importance of Training
  • Implementation of any ICH GLs in a Stepwise Fashion
  • Interest in Specific Topics (GMP for APIs, GCP, Ethnic Factors, Stability)
challenging topics in ich6 conference
Challenging Topics inICH6 Conference
  • Shared Experience on the Implementation of CTD
  • New Pharmacovigilance Topics
  • Quality Systems for the 21st Century (GMP)
  • Comparability of Biotechnological/Biological Products
  • Safety Pharmacology and Clinical Evaluation of QT/QTc Interval Prolongation
  • Partnerships in Harmonisation
  • Future Challenges facing ICH
  • Gene Therapy
do not miss the forthcoming ich6
Do not miss the forthcoming ICH6!

Final Announcement


Conference Registration and Hotel Reservation are accessible

ich in future
ICH in future
  • Timely Access of Innovations for Patients around the World
  • Changing Environment – Regulations and Sciences
  • Maintenance and Implementation – CTD and GLs
  • Pharmacovigilance
  • Transparency – Global Cooperation, Large Conference
ich website
ICH Website
  • Written Information Available on ICH Website:


  • ご清聴ありがとうございました

  Thank You