Outline

O ICH History
O Mission
O Need to harmonize
O Initiation of ICH
O Structure
O Observers
O Organization
O Process of harmonization
O The Guideline-QSEM
 History of ICH
O The International Conference on Harmonization (ICH) of
technical requirements for registration of pharmaceuticals for
human use was initiated in April 1990.

O 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.

O ICH had the initial objective of coordinating the regulatory

activities of the European, Japanese, and the United States
bodies (along with the pharmaceutical trade associations from
these three regions), to discuss and agree the scientific and
technical aspects arising from product registration.
 MISSION of ICH
O 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.
 Need to Harmonize
O Realization was driven by tragedies, such as
that with thalidomide in Europe in the
1960s.
O 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.
O Divergence in technical requirements from
country to country
 Initiation of ICH
O Harmonizationof regulatory requirements was pioneered by
Europe Community (Now EU)

O Success achieved by Europe demonstrated that harmonization was

possible

O At same time there were bilateral discussions between Europe,

Japan & US, on possibilities for harmonization

O The birth of ICH took place at meeting in April 1990 in Brussels

O Topics selected for harmonization –
- SAFETY
- QUALITY
- EFFICACY
 Evolution of ICH
O Two decades of success, attributed by scientific consensus
& the commitment between industry and regulatory parties.

O First decade saw significant progress in the development of

tripartite ICH guidelines on SAFETY, QUALITY & EFFICACY
topics and also on Multidisciplinary topics (MedDRA, CTD)

O Expanded communication & dissemination of information on

ICH guidelines with Non-ICH regions

O Establishment of Global Cooperation Group (GCG) – in

response to a growing interest from beyond the ICH region
in the use of ICH guidelines
Evolution of ICH
 Observers of ICH
O WHO, EFTA (European Free Trade Association),
Canada, Australia – Non voting members

O IFPMA (International federations of Pharmaceutical

Manufacturers Association) representative
Organization
 Steering Committee
O Governing body that overseas the harmonization
activities

O Six co-sponsors has two seats on the SC

(EU, EFPIA, MHLW, JPMA, USFDA, PhRMA)

O 3 Observers are WHO, Health Canada, European

Free Trade Association (EFTA)

O The IFPMA host the ICH secretariat & participants as

a non-voting member
 ICH Working Groups
O 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

O 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
O 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
 The Guidelines – Q S E M
O Quality (Q1-Q11)
- chemical & Pharmaceutical QA

O Safety (S1-S10,M3)
- dealing with in-vitro & in-vivo preclinical testing

O Efficacy (E1-E16, Except E13)

- clinical studies in human beings

O Multidisciplinary (M1-M8)
-terminology, electronic standards, common documents
 Quality
O Q1-Stability
O Q2-Analytical Validation
O Q3-Impurities
O Q4-Pharmacopoeias
O Q5-Quality of Biotechnological Products
O Q6-Specifications
O Q7-Good Manufacturing Practice
O Q8-Pharmaceutical Development
O Q9-Quality Risk Management
O Q10-Pharmaceutical Quality System
 Safety
O S1-Carcinogenicity Studies
O S2-Genotoxicity Studies
O S3-Toxicokinetics and Pharmacokinetics
O S4-Toxicity Testing
O S5-Reproductive Toxicology
O S6-Biotechnological Products
O S7-Pharmacology Studies
O S8-Immunotoxicology Studies
O S9-Nonclinical evaluation for anticancer
pharmaceuticals
O S10-Photosafety Evaluation
 Efficacy
O E1&E2-Clinical Safety
O E3-Clinical Study Reports
O E4-Dose-Response Studies
O E5-Ethnic Factors
O E6-Good Clinical Practice
O E7,E8,E9,E10&E11-Clinical Trials
O E12-Guidelines for Clinical Evaluation by Therapeutic
Category
O E14-Clinical Evaluation
O E15&E16-Pharmacogenomics
 Conclusion
O ICH launched 20 years ago

O 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.

O 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.