ICH guidelines History of ICH guidelines Members of ICH guidelines

1. ICH Guidelines
Prepared by
Varsha Jindaniya
M.Pharm Pharmaceutical
Department of NIET college

2. Introduction
History
Members of ICH Guidelines
Introduction-The International Council for Harmonisation of Technical
Requirements for pharmaceutical human use ICH guidelines use to
maintain the efficacy, safety and quality of drugs.
ICH guidelines motives to provide uniform standards for technical
requirements for pharmaceuticals for human use.
ICH aims to provide uniform standards for technical requirements for
pharmaceuticals for human use

3. Quality- Stability, impurity, GMP etc .It's all about the quality assurance .
There are 14 guidelines in quality assurance.
Safety- In this safety guidelines the carcinogenicity, genotoxicity,
reprotoxicity etc it's all comes under this safety guidelines. There are
11guidelines in safety.
Efficacy- In this guidelines the clinical trials, pharmacogenomics, pharma
vigilance etc all are comes under this efficacy guidelines. There are total 18
guidelines comes in this.
Multidisciplinary- Med. DRA, CTD (common tech documents) , electronics
STD etc all are in this guidelines.
There are 10 guidelines in this.

4. Members of ICH -
1. In Japan - Ministry of Health Labour and Welfare (MHLW)
Japan Pharmaceutical Manufacturing Association (JPMA)
2. In Europe- The Members are the European Union (EU)
European Federation of Pharmaceutical Industries and Association (EFPIA)
3. In USA - The Members are The Food and Drugs Administration (FDA)
The Pharmaceutical Research and Manufacturers of America (Pharma)
Additional Members + Observers
WHO, EFTA(European Free Trade Association), Canada, Australia, Non- voting
Members
IFPMA(International Federation of Pharmaceutical Manufactures Association)
Representative.
These all members are as a observers.

5. History-
1980 - European community
1989 - WHO Conference on Drug Regulatory Authorities
This conference conduct in Paris.
1990 - Birth of ICH. this conference conduct in Brussels.
-Europe, Japan, USA
This conference is conducted by European Federation of
Pharmaceutical Industries (EFPIQ) in Brussels.
Six Party Experts Working Groups
1990 - In Tokyo steering Committee.
Commitment and process decides in this conference.

6. Thank you