The international council for harmonization

The international council for harmonization:

The international council for harmonization of Technical requirements for pharmacuticalsfor human use(ICH).It is a joint initiative of regulators and industry manufacturers of the Europe Union, Japan and the United States of America (U.S.A.)to carry out scientific and technical discussions of the testing procedures required to assess and ensure the safety, quality and efficacy of medicines.
The Activity of ICH falls into 4 catogories
 Quality: Harmonisation achievements in the Quality area such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

 Safety:ICH has produced to set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity

 Efficacy :The work concerned with the design, conduct, safety and reporting of clinical trials.

 Multidisciplinary:It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).


ICH was formed after meeting that hosted by EFPIA in Brussels in 1990.

 To prevent/reduce the duplication of the clinical trials
 development of new pharmaceutical products. It does so by
 guidelines for testing, application and registration of pharmaceutical products

Different topics that are assigned with some codes under the category.
For example;
Q1: Stability testing;
Q2: Validation;
Q3: Impurities;

• The ICH comprises of the ICH Steering Committee (SC),
• ICH Coordinators
• ICH Secretariat and ICH Working Groups
• The ICH Medical Dictionary of Regulatory Activities (MedDRA).
• The Global Cooperation Group (GCG)

Members of Steering Committee

The Steering Committee, made of six ICH Parties,
The ICH consists of:
• European Commission
• Europeasn Federation of Pharmaceutical Industries and Associations (EFPIA)
• Ministry of Health, Labour and Welfare (Japan)
• Japan Pharmaceutical Manufacturers Association (JPMA)
• Food and Drug Administration (FDA)
• Pharmaceutical Research and Manufacturers of America (PhRMA)

ICH Guidelines are Available Online:


August 1, 2017

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