This document provides an overview of the International Conference on Harmonization (ICH) which brings together regulatory authorities from Europe, Japan, and the US to discuss scientific and technical requirements for pharmaceutical products. The objectives of ICH are to reduce costs by harmonizing legislative and technical requirements and reducing duplicative research, as well as to reduce the time needed for global drug marketing approval. ICH guidelines are developed through a 5-step process and cover topics related to pharmaceutical quality, efficacy, safety, and multidisciplinary issues.

1. Guidelines
ICH
Rimita Laskar
Roll Number – 40
Subject – Industrial Pharmacy
Slot – 1st (CA1) Code – PT716A
Year – 4th Semester – 7th
Session – 2022-2023
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2. Also known as "International
Conference on Harmonization
of Technical requirements for
Pharmaceuticals for Human
Use"
Project, that brings
together regulatory
authorities of Europe,
Japan & US, to discuss
scientific & technical
aspects of pharmaceutical
product registration.
GENERAL INTRODUCTION

3. Harmonization of legislative & technical requirements
To reduce cost of research work duplications
To reduce time-frame for global marketing of newer drugs
after approval
To maintain & formulate guidelines on quality, safety &
efficacy-based regulations, for consumer & patient benefits.
OBJECTIVES OF ICH
LOCATION OF ICH
• The ICH Secretariat is based in Geneva
• Biennial meetings & conferences of ICH Steering Committee > shuffle
between the European Union, Japan & the US.

4. • Japan Pharmaceutical Manufacturers Association(JPMA)
In Japan, the members include:
• European Union(EU)
In Europe, the members include:
• Food and Drug Administration(FDA)
In the USA, the members include:
• Observers from the WHO(represent non-ICH countries & regions)
• Canada
Additional members include:
ICH MEMBERS
• ICH consists of representatives
from 6 parties that represent
the regulatory bodies &
research-based industry in the
EU, Japan & the USA

5. •Drafts are prepared
•circulated through
many revisions
•leads to assimilation
of a "final harmonized
draft"
STEP 1
•Draft is signed by
EWG
•forwarded to
Steering Committee
for signing
•sigmfies acceptance
for consultation by
each of the 6 co-
sponsors
STEP 2
•3 regulatory
sponsors
•initiate their normal
consultation
process to receive
comments.
STEP 3
• Reached, when the
Steering Committee
agrees that there is
sufficient scientific
consensus on technical
issues
• This endorsement is
based on signatures
from the 3 regulatory
parties to ICH affirming
that the Guideline is
recommended for
adoption by the
regulatory bodies of
the 3 regions.
STEP 4
•Guidelines
• incorporated into
national/ regional
internal
procedures(implem
entation in the 3
ICH regions).
STEP 5
THE ICH PROCESS
• There are 5 steps involved

6. QUALITY(Q)
EFFICACY(E)
SAFETY(S)
MULTIDISCIPLINARY(M)
•Refer to topics related to chemical &
pharmaceutical Quality Assurance
•Stability testing
•Impurity testing, etc.
•Refers to topics, that deal with clinical
studies in human subjects Include
•Dose - Response studies
•Good Clinical Practices, etc.
•Refers to topics, that deal with in-vitro &
in-vivo pre-clinical studies .
•Carcinogenicity testing
•Genotoxicity testing, etc.
•Refer to topics, that do not fit uniquely
into any of the above categories
•Hence also known as "cross-cutting
topics"
ICH GUIDELINES
• ICH guideline topics include:

7. Thank you…