A case study in the value of harmonisation
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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.)

Harmonisation process mickey mouse way of progress

Harmonisation Process(“Mickey Mouse” Way of Progress!!)






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

Number of consultation

Number of Consultation

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)

A case study in the value of harmonisation

ICH6 Program (Nov. 2003)

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

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