The document discusses the goals and process of the International Conference on Harmonization (ICH). The ICH aims to harmonize technical requirements for pharmaceutical registration across regions to increase efficiency and access to new medicines while maintaining quality and safety. The ICH process involves developing guidelines through formal procedures, answering questions, revising existing guidelines, and maintaining established standards.

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