Draft GMP Guidelines For Comments
Since 2002, MHLW health science grant study on Desired state and methods of modern pharmaceutical quality control system has been conducted with a number of professionals from various fields. At the end of fiscal 2003, the study group assembled three guidance documents: GMP, Technology Transfer, and Quality Control Laboratory.
The study group accepts comments on three draft guidance documents to finalize the documents. They are posted at a home page of the National Institute of Health Sciences
- GMP guidance (Japanese , English under construction)
- Technology Transfer guideline ( Japanses , English part 1, part 2)
- Quality Control Laboratory guideline ( Japanese , English-under construction)
Constructive comments may be sent to GMP@nihs.go.jp by September 24, 2004.
Comments should be written in Japanese or in English. At the beginning of comments, name of guidance, name of organization, organization function should be written. Reasons for comments are highly appreciated.
Principal Scientist of the Grant Study
Yukio Hiyama, Ph.D.
Chief, Third SectionCDivision of Drugs
National Institute of Health Sciences
1-18-1 Kamiyohga, Setagayaku, Tokyo 158-8501
To Drugs Division Home Page
Last edition:Sept. 22, 2004