ICH

ICH
Harmonization for Better Health

Benhur Pradeep

http://www.myclinicalresearchbook.blogspot.com

Outline
 ICH
 Mission
 Need to Harmonize
 Initiation of ICH
 Structure
 Observers
 Organization
 Process of Harmonization
 Work Products
 The Guidelines – Q S E M

The purpose of clinical research is to create knowledge
needed to improve healthcare. Without such
knowledge, action for healthcare may be
impossible, wasteful, expensive or harmful because it will
have no logical or empirical basis.


ICH (April 1990)
 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.


Mission
 To make recommendations towards acheiving greater
harmonization in the interporetation 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.


Need to Harmonize
 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


Initiation of ICH
 Harmonization of regulatory requirements was pioneered by
European Community (Now EU)
 Success acheived by Europe 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 in April 1990 in Brussels
 Topics selected for harmonization –
- SAFETY
- QUALITY &
- EFFICACY

Evolution 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
 Estb. Global Cooperation Group (GCG) – in response to a growing
interest from beyond the ICH region in the use of ICH guidelines


Structure
Regulatory Body Industry

Ministry of European
US Food & Pharmaceutical
Health, Labo Federation of Japan
Research &
European Drug Pharmaceutical Pharmaceutical
r and Industries Association
Manufactures
Union (EU) Administrati of America
Welfare, Jap Associations (JPMA)
on (US-FDA) (PhRMA)
an (MHLW) (EFPIA)


Observers
 WHO, EFTA (European Free Trade Association), Canada, Austrila –
Non voting members

 IFPMA (International federations of Pharmaceutical Manufactures
Association) representative


Organization


Steering Committee
 Governing body that overseas the harmonization activities
 Six co-sponsors has two seats on the SC
(EU, EFPIA, MHLW, JPMA, USFDA, PhRMA)
 3 Observers are WHO, Health Canada, European Free Trade
Association (EFTA)
 The IFPMA host the ICH secretarist & participartes as a non-voting
member


GCG & MedDRA Management Board
 Global Cooperation Group represents from 5 Regional
Harmonnizational Initatives (RHI‘s) APEC, ASEAN, EAC, GCC,
PANDRH, SADC

 MedDRA mngt. Board:- Overall responsibility for direction of
MedDRA.
 MedDRA an ICH stansardised 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


Secretariat & Coordinators
 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


ICH Working Groups
 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
- Discussion Group


Process of Harmonization
 ICH harmonization activities fall into 4 categories
- 1. Formal ICH Procedure: New topic for Harmonization
- 2. Q&A Procedure: Clarification on existing guideline
- 3. Revision Procedure
- 4. Maintenance Procedure


Work Products
 1. ICH Guidelines
 2. MedDRA
 3. CTD
 4. Electronic Standards
 5. Consideration Documents
 6. Open Consultations


The Guidelines – Q S E M
 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 documents

Quality
 Q1-Stability
 Q2-Analytical Validation
 Q3-Impurities
 Q4-Pharmacopoeias
 Q5-Quality of Biotechnological Products
 Q6-Specifications
 Q7-Good Manufacturing Practice
 Q8-Pharmaceutical Development
 Q9-Quality Risk Management
 Q10-Pharmaceutical Quality System

Safety
 S1-Carcinogenicity Studies
 S2-Genotoxicity Studies
 S3-Toxicokinetics and Pharmacokinetics
 S4-Toxicity Testing
 S5-Reproductive Toxicology
 S6-Biotechnological Products
 S7-Pharmacology Studies
 S8-Immunotoxicology Studies
 S9-Nonclinical evaluation for anticancer pharmaceuticals
 S10-Photosafety Evaluation

Efficacy
 E1&E2-Clinical Safety
 E3-Clinical Study Reports
 E4-Dose-Response Studies
 E5-Ethnic Factors
 E6-Good Clinical Practice
 E7,E8,E9,E10&E11-Clinical Trials
 E12-Guidelines for Clinical Evaluation by Therapeutic Category
 E14-Clinical Evaluation
 E15&E16-Pharmacogenomics


Multidisciplinary
 M1-MedDRA Terminology
 M2-Electronic Standards
 M3-Non-clinical Safety Studies
 M4-CTD
 M5-Data elements & Standards for Drug dictonaries
 M6-Gene Theraphy
 M7-Genotoxic Impurities
 M8-eCTD


Conclusion
 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.


Thank You
Benhur Pradeep
Pradeep.ben84@gmail.com


www.presentationpoint.com

ICH

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