The document discusses the International Council for Harmonisation (ICH), a joint regulatory initiative between Europe, Japan, and the United States to harmonize technical requirements for pharmaceutical product registration. The ICH seeks to streamline development and review processes, reduce unnecessary testing on humans and animals, and ensure safety, quality and efficacy globally. Key topics covered include ICH objectives and members, guidelines produced on quality, safety, efficacy and multidisciplinary issues, and the process for harmonizing requirements.

1. ICH(International Council on
Harmonization) Guideline
Presented by
Aishwarya C.
Patil.
M.Pharm(first year)
Pharmaceutics
Rajarambapu College Of Pharmacy
Kasegaon

2. What does ICH stands for?
The complete name of ICH is the
"International Conference on
Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for
Human Use".

3. Definition
 ICH is a joint initiative involving both
regulators and research-based industry
representatives of the EU, Japan and
the US in scientific and technical
discussions of the testing procedures
required to assess and ensure the
safety, quality and efficacy of medicines.

4. Objective -
1] More economical, use of humans,
animal and for material resources.
2] Elimination of unnecessary delay in
the global development and availability
of -new medicines.
3] Maintaining safeguards on quality
safety efficacy and regulatory obligation
to protect public health.

5.  Members of ich guidelines –
 European Commission - European Union
(EU).
 European Federation of Pharmaceutical
Industries and Associations (EFPIA).
 Ministry of Health, Labour and Welfare,
Japan (MHLW).
 Japan Pharmaceutical Manufacturers
Association (JPMA).
 US Food and Drug Administration (FDA).
 Pharmaceutical Research and Manufacturers
of America (PhRMA).

6. History Need to harmonise?
 –Industry becoming global
 – Duplicate test procedures
• Time consuming
• Expensive
 – Increasing R&D costs
 – Meeting public demand

7. History :
Initiation of ICH
– 1980s: European Community
– 1989: WHO conference on Drug Regulatory
Authorities, Paris
– 1990: Birth of ICH, Brussels
• Europe
• Japan
• US
– Topics for harmonisation divided into: Safety,
Efficacy and Quality

9. 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

10. 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.

11. 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

12. 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

13. 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

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

15. QSEM GUIDELINES
 1.Quality(Q) Guideline
 2.Safety(S) Guideline
 3.Efficacy(E)Guideline
 4.Multidisciplinary(M)Guideline

17.  1. Quality Guidelines:
 Harmonization achievements in the
Quality area include pivotal milestones
such as the conduct of stability
studies, defining relevant thresholds
for impurities testing and a more
flexible approach to pharmaceutical
quality based on Good Manufacturing
Practice (GMP) risk management

18. 2.Safety Guidelines:
ICH has produced a comprehensive set
of safety Guidelines to uncover potential
risks like carcinogenicity, genotoxicity
and reprotoxicity. A recent breakthrough
has been a non-clinical testing strategy
for assessing the QT interval
prolongation liability: the single most
important cause of drug withdrawals in
recent years

19.  3.Efficacy Guidelines
 The work carried out by ICH under the
Efficacy heading is concerned with the
design, conduct, safety and reporting
of clinical trials. It also covers novel
types of medicines derived from
biotechnological processes and the
use of pharmacogenetics/genomics
techniques to produce better targeted
medicines

20.  4.MULTIDISCIPLINARY GUIDELINES:
 Those are the cross-cutting topics which
do not fit uniquely into one of the Quality,
Safety and Efficacy categories. It
includes the ICH medical terminology
(MedDRA), the Common Technical
Document (CTD) and the development
of Electronic Standards for the Transfer
of Regulatory Information
(ESTRI).REFERENCE- ICH Guidelines/
Work Products

22.  Reference –
 1.(Werner Nicklas International
Harmonization of Health Monitoring ILAR
Journal, Volume 49, Issue 3, 1 January
2008, Pages 338–
346,https://doi.org/10.1093/ilar.49.3.338
 2.Mario Chen Family Health International
Biostatistics Workshop NewDelhi, India,
March2004
 3.https://en.wikipedia.org/.../International_C
ouncil_for_Harmonisation_of_Technical_Re
q...)
 4.ICH Guidelines/ Work Products
