ICH ....

ICH
INTERNATIONAL CONFERENCE ON
HARMONIZATION
HARMONIZATION FOR BETTER
HEALTH

International conference on harmonization
It is a joint initiative involving regulators &
industry as equal partners in the scientific &
technical discussions of the testing procedures
which are required to ensure and assess the safety,
quality & efficacy of medicines.
HTTP://WWW.MYCLINICALRESEARCHBOOK.BLOGSPOT.CO
M
ICH (April 1990)

To make recommendations towards
achieving greater harmonization in the
interpretation and application of technical
guidelines and requirements for
pharmaceutical product registration, there by
reducing duplicating of testing carries out
during the research & development of new
human medicines.
HTTP://WWW.MYCLINICALRESEARCHBOOK.BLOG
SPOT.COM
Mission

Realisation was driven by tragedies, such as that
with thalidomide in Europe in the 1960s.
The 1960s and 1970s saw a rapid increase in laws,
regulations and guidelines for reporting and
evaluating the data on safety, quality and efficacy of
new medicinal products.
Divergence in technical requirements from
country to country.
SPOT.COM
Need to Harmonize

Harmonization of regulatory requirements was pioneered by
European Community (Now EU)
Success acheived by Europe when it demonstrated that
harmonization was possible
At same time there were bilateral discussions between Europe,
Japan & US, on possibilites for harmonization
The birth of ICH took place at meeting of EFPIA [European
Federation of Pharmaceutical Industries and
Associations] in April 1990 in Brussels
Topics selected for harmonization –
SAFETY
QUALITY
EFFICACY
SPOT.COM
Initiation of ICH

Two decades of success, attributed by scientific concensus
& the commitment between industry and regulatory
parties.
First decade saw significant progress in the development
of tripartitie ICH guidelines on SAFETY, QUALITY &
EFFICACY topics and also on Multidisciplanary topics
(MedDRA, CTD)
Expanded communication & dessemination of
information on ICH guidelines with Non-ICH regions
Estblishment of Global Cooperation Group (GCG) – in
response to a growing interest from beyond the ICH
region in the use of ICH guidelines HTTP://WWW.MYCLINICALRESEARCHBOOK.BLOG
SPOT.COM
Evolution of ICH

SPOT.COM
Structure of ICH
Regulatory Body
European
Union
(EU)
Ministry
of Health,
Labor and
Welfare,
Japan
(MHLW)
US Food
& Drug
Administr
ation
(US-FDA)
Industry
European
Federation
of
Pharmaceuti
cal
Industries
Associations
(EFPIA)
Japan
Pharmaceuti
cal
Association
(JPMA)
Pharmaceuti
cal Research
&
Manufactur
es of
America
(PHRMA)

 WHO, EFTA (European Free Trade
Association)untill 2014, Canada, Swissmedic
Non voting member:
 IFPMA (International federations of
Pharmaceutical Manufactures Association) –
SPOT.COM
Observers:

SPOT.COM
Organization

Governing body that overseas the harmonization activities
Six representative of founding parties on the SC (EU, EFPIA,
MHLW, JPMA, USFDA, PhRMA)
3 Observers are WHO, Health Canada, Swissmedic.
The IFPMA participates as a non-voting member
SPOT.COM
Steering Committee

Global Cooperation Group represents from 6 Regional
Harmonnizational Initiatives (RHI‘s) APEC [Asia-Pacific
Economic Cooperation], ASEAN [Association of
Southeast Asian Nations], EAC[East African
Community], GCC [Gulf Cooperation Council],
PANDRH [Pan American Network for Drug Regulatory
Harmonization], SADC [Southern African
Development Community], in addition to eight Drug
Regulatory Authorities/Department of Health (DRAs/DoH)
namely Australia, Brazil, China, Chinese Taipei, India,
Republic of Korea, Russia and Singapore, are invited in the
ICH bi-annual meetings.
SPOT.COM
GCG & MedDRA Management Board

MedDRA management Board:- Overall responsibility for
direction of MedDRA.
MedDRA (Medical Dictionary for Regulatory Activities) is an
ICH‘s standardized dictonary of medical terminology.
The board oversees the activites of MedDRA “Maintenance and
Support Services“ (MSSO) which serves as the repository,
maintainer, developer and distributor of MedDRA
SPOT.COM
GCG & MedDRA Management Board

The MedDRA Management Board is composed of the six ICH
Parties (EU, EFPIA, MHLW, JPMA, FDA, PhRMA), the
Medicines and Healthcare products Regulatory Agency (MHRA) of
the UK, Health Canada and the WHO (as Observer). The IFPMA
acts as a non-voting observer on the Management Board.

Secretariat located in Geneva, Switzerland, operating
from IFPMA offices
Secretariat staff is responsible for day to day management
of ICH, namely preparations for & documentation of,
meetings of the SC and its working group
Coordinators: fundamental to the smooth running of
ICH.
European Union (EU), Ministry of Health, Labour and
Welfare (MHLW), Pharmaceuticals and Medical Devices
Agency (PMDA), FDA, Health Canada, EFPIA, JPMA
and PhRMA.
Secretariat & Coordinators

Each party establishes a contact network of experts
with in their own organization or region in order to
ensure that, in the discussions they reflect the views &
policies of the co-sponsor they represent.
There are several different types of ICH working
groups
EWG: Expert Working Group
IWG: Implementation Working Group
Informal Working Group HTTP://WWW.MYCLINICALRESEARCHBOOK.BLOG
SPOT.COM
ICH Working Groups

ICH harmonization activities fall into 4 categories
1. Overview
2. Initiation of ICH harmonisation action
3. Full ICH harmonisation process for major topics
4. Abbreviated process for maintenance of ICH
agreements
5. Type of maintenance: updating based on new
information
SPOT.COM
Process of Harmonization

OVERVIEW:
 Steering committee ensure that
 1. Harmonize new technical requirement
 2. Updating and supplementing current ICH
guideline
 3. Working procedure have been agreed
 Major harmonisation – new guideline, change in
existing guideline, change in policy
 Minor harmonisation – other changes

INITIATION OF ICH HARMONISATION
ACTION:
1. Proposal for harmonisation action
I. New types of medicinal product
II. Lack of harmonisation in current technical
requirements
III. Transition to technically improved testing procedures
IV. Review of an existing ICH guideline
V. Maintenance of existing guideline
2. Preparation of concept paper – 2 pages summary of
proposal
3. Selection of procedure – I to IV full ICH process, V –
ICH secretariat
HERE COMES YOUR FOOTER  PAGE 18

FULL ICH PROCESS FOR MAJOR
HARMONISATION TOPICS:
 1. Topic selection
 2. Steering committee action – objective, EWG, timeline
 3. Expert working groups – report to SC
 4. Timetables and action plan – 2 years
 5. Steps in ICH process
 A. Consensus building
 B. Start of regulatory action
 C. Regulatory consultation
 D. Adoption of a tripartite harmonised text
 E. Implementation

ABBREVIATED PROCESS FOR MAINTENANCE
OF ICH AGREEMENTS:
1. Contact network for maintenance of guidelines
2. Procedure: Maintenance network – concept paper,
review and sign off
3. Procedure: steering committee
Types of maintenance
1. Proposal on permitted daily exposure (PDE)
2. Revision of established PDE
3. Publish relevant information of ICH website
4. Request revision of pharmacopoeias
5. Request WHO to distribute information to non ICH region

1. ICH Guidelines
2. MedDRA
3. CTD [common technical document]
4. Electronic Standards
5. Consideration Documents
6. Open Consultations
SPOT.COM
Work Products

Quality (Q1-Q11)
chemical & Pharmaceutial QA
Safety (S1-S10,M3)
dealing with invitro & invivo preclinical testing
Efficacy (E1-E16, Except E13)
clinical studies in human beings
Multidiscilplinary (M1-M8)
terminology, electronic standards, common documentsHTTP://WWW.MYCLINICALRESEARCHBOOK.BLOG
SPOT.COM
The Guidelines – Q S E M

Q1A-Q1F-Stability
Q2-Analytical Validation
Q3A-Q3D-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 - Lifecycle Management
SPOT.COM
Quality

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 HTTP://WWW.MYCLINICALRESEARCHBOOK.BLOG
SPOT.COM
Safety

 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,E8,E9,E10&E11-Clinical Trials
 E12-Clinical Evaluation by Therapeutic Category
 E14-Clinical Evaluation
 E15-Definitions in Pharmacogenetics / Pharmacogenomics
 E16-Qualification of Genomic Biomarkers
 E17-Multi-regional clinical trials
 E18-Genomic sampling
SPOT.COM
Efficacy

M1-MedDRA Terminology
M2-Electronic Standards
M3-Non-clinical Safety Studies
M4-CTD
M5-Data Elements & Standards for Drug dictionaries
M6-Gene Therapy
M7-Genotoxic Impurities
M8-eCTD
SPOT.COM
Multidisciplinary

ICH launched 20 years ago
ICH brings together the drug regulatory authorities of
Europe, Japan, and the United States, along with the
pharmaceutical trade associations from these three
regions, to discuss scientific and technical aspects of
product registration.
It is ICH’s mission to achieve greater harmonization in
the interpretation and application of technical guidelines
and requirements for product registration, thereby
reducing duplication of testing and reporting carried out
during the research and development of new medicines.HTTP://WWW.MYCLINICALRESEARCHBOOK.BLOG
SPOT.COM
Conclusion

ICH ....

Recommandé

Recommandé

Contenu connexe

Tendances

Tendances (20)

Similaire à ICH ....

Similaire à ICH .... (20)

Plus de Suvarta Maru

Plus de Suvarta Maru (20)

Dernier

Dernier (20)

ICH ....