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
(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.