HITACHI : Hitachi's Solutions Regarding Latest Trends in Pharmaceutical Regulations and Pharmaceutical Industry

	May 2005
	Industrial Systems

AUTHORS

Junichiro Tomimatsu	Pharma and Biotech Systems Dept., Total Solutions Div., Hitachi, Ltd.
kazuhide Furihata	Medical Systems Management Dept., Industrial Systems Div., Information & Telecommunication Systems, Hitachi, Ltd.
Sei Murakami, Ph.D	Industrial Systems Div., Power & Industrial Systems, Hitachi, Ltd.
Junko Ito	Pharma and Biotech Systems Dept., Total Solutions Div., Hitachi, Ltd.
Eiichi Isoda	Pharma and Biotech Systems Dept., Total Solutions Div., Hitachi, Ltd.
Haruhiko Araki	Pharma and Biotech Systems Dept., Total Solutions Div., Hitachi, Ltd.
Jun Taniguchi	Pharma and Biotech Systems Dept., Total Solutions Div., Hitachi, Ltd.

OVERVIEW

As an industry that provides products for protecting the public's health, the pharmaceutical industry is required to observe a great many regulations. Regarding these regulations, which have traditionally been set up individually according to different countries and regions, The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was set up in 1990 as a trilateral partnership between the regulatory authorities of Japan, the USA, and the European Union (EU). Since then, in cooperation with the main trade organizations of the pharmaceutical industry, the ICH has been standardizing regulations on drugs. In recent years, the pharmaceutical industry of Japan has steadily expanded into overseas markets and, consequently, has faced challenges concerning compliance with internationally standardized regulations. Moreover, accompanying the popularization of computers and the electronization of drug-application procedures, the improvement of regulations concerning this digitization is being continued. At the same time, as records and signatures required by pharmaceutical regulations become digitized, standards for assuring their reliability are being established. Orchestrating its collective strength and applying the experience it has accumulated up till now, Hitachi is supporting the pharmaceutical industry in its efforts to comply with the latest pharmaceutical regulations.

TO READ THIS ARTICLE

See PDF file for details(PDFformat, r2005_may_001.pdf, 212KB)

RELEVANT SITES

	U.S. Food and Drug Administration
	European Medicines Agency
	Ministry of Health, Labour and Welfare (Japan)
	The Hitachi Hyoron (Japanese Only)

KEYWORDS

GxP, pharmaceutical, regulation, validation, Part 11

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