intertnational council for harmonization The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects Details of the ICH guidelines for pharmaceutical quality from Q1 to Q12 including stability analysis, evaluation of impurities and quality risk management. ICH (Full form = International Conference on Harmonisation) is a committee that provides the pharmaceutical guidelines for industries.

1. ICH
Akshay Trivedi
M.Pharm
Pharmaceutical Quality Assurance Department

2. ICH
 International council for harmonization (After nov 2015)
 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.

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

4. ICH (2015)
 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.

5. Mission
 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.

6. Need to harmonize
 Realization 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

7. Initiation of ICH
 Harmonization of regulatory requirements was pioneered
by European Community (Now EU)
 Success achieved by Europe demonstrated that
harmonization was possible
 At same time there were bilateral discussions between
Europe, Japan & US, on possibilities for harmonization
 The birth of ICH took place at meeting in April 1990 in
Brussels
 Topics selected for harmonization –
- SAFETY
- QUALITY &
- EFFICACY

8. Evolution of ICH
 Two decades of success, attributed by scientific consensus
& the commitment between industry and regulatory parties.
 First decade saw significant progress in the development of
tripartite ICH guidelines on SAFETY, QUALITY &
EFFICACY topics and also on Multidisciplinary topics
(MedDRA, CTD)
 Expanded communication & dissemination of information
on ICH guidelines with Non-ICH regions
 Est. Global Cooperation Group (GCG) – in response to a
growing interest from beyond the ICH region in the use of
ICH guidelines

9. Structure

10. Observers
 WHO, EFTA (European Free Trade Association), Canada,
Australia – Non voting members
 IFPMA (International federations of Pharmaceutical
Manufactures Association) representative

11. Organization

12. 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 secretariat & participates as a
non-voting member

13. GCG & MedDRA Management Board
 Global Cooperation Group represents from 5 Regional
Harmonization Initiatives (RHI‘s) APEC, ASEAN, EAC,
GCC, PANDRH, SADC
 MedDRA mint. Board:- Overall responsibility for direction of
MedDRA.
 MedDRA an ICH standardized dictionary of medical
terminology
 The board oversees the activates of MedDRA
“Maintenance and Support Services“ (MSSO) which serves
as the repository, maintainer, developer and distributor of
MedDRA

14. 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

15. 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

16. 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

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

18. The Guidelines – Q S E M
 Quality (Q1-Q14)
- chemical & Pharmaceutical QA
 Safety (S1-S11)
- dealing with invitro & in vivo preclinical testing
 Efficacy (E1-E19, Except E13)
- clinical studies in human beings
 Multidisciplinary (M1-M11)
- terminology, electronic standards, common documents

19. Quality Guidelines
 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
 Q11-Development and manufacturing of drug substances
 Q12-Life cycle
 Q13-Continous manufacturing of drug substances and drug products
 Q14-Analytical procedure development

20. 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.

21. THANK YOU