ICH goals and process

1. ICH goals and
Process
Made by Kashish Wilson
MMCP MM(DU) Mullana Ambala

2. Contents:-
 Introduction to ICH
 Goal of ICH
 ICH Guidelines
 ICH Process

3. (A) Introduction to ICH
 ICH Stands for “International conference on harmonization of technical requirements for
registration of pharmaceuticals for human use”.
 ICH mission is to make recommendations towards achieving greater harmonization in the
interpretation and application of technical Guidelines and requirements for pharmaceutical
product registration.
(B) Objective of ICH
 To achieve greater consistency in technical guidelines.
 More economical use of human and material resources.
 More development and availability of new medicine while safeguarding it’s quality and efficacy.
(c) Need for ICH
. Rising costs of health care.
. Escalation of the cost of R&D.
. Need to meet public expectation.

4. (D) Goal of ICH
 To promote international harmonization
 To make information available
 To strength the capacity of authorities and
industries
(E) ICH Guidelines

5. (F) ICH PROCESS
it falls into 4
categories:-
1) Formal ICH
procedure (2) Q&A
(3) Revision
procedure (4)
Maintenance
procedure