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Friday, June 4, 2010

ICH International Conference on Harmonisation

What is (ICH) or International Conference on Harmonisation (ICH) what is its role in pharmaceutical industry?
The International Conference on Harmonisation (ICH):
The International Conference on Harmonisation is a common body or organization of regulatory authorities of Europe, Japan and the United States and pharmaceutical industry representatives or experts from these three regions of they discuss and help each other in forming and implementing technical requirements for registration of pharmaceuticals for human use and harmonizing between FDA’S or regulatory authorities in these region and Pharmaceutical companies
The International Conference on Harmonisation (ICH) is a project that brings together pharmaceutical companies and FDA’S or regulatory authorities of Europe, Japan and the United States and help each other to discuss , form , and implement scientific and technical aspects of pharmaceutical product registration.

The International Conference on Harmonization (ICH) recommend and harmonize or help in the interpretation and purpose of technical guidelines and requirements for product registration.
This prevent or reduce duplication of work and the testing carried out during the research and development of new medicines by ways to achieve greater.
This helps in efficient and economical use resources of human, animal and material, and reduces needless hindrance availability of new drugs and in the global development without compromising regulatory obligations and safeguards of quality, safety, and efficacy, and to protect public health.

ICH guidelines are adopted as law in several countries, where as they are used only as a guidance for Pharmaceutical industry in US, the pharmaceutical companies in USA are regulated by US FDA regulations.

Following regulatory bodies and pharmaceutical industry organizations, founding members are responsible for the decision making process:
1.The European Commission,
2.The European Federation of Pharmaceutical Industries and Associations (EFPIA),
3.The Ministry of Health, Labour and Welfare,
4.The Japan Pharmaceutical Manufacturers Association (JPMA)
5.The Food and Drug Administration (FDA),
6.The Pharmaceutical Research and Manufacturers of America (PhRMA)

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