New in JKS Document Store
Tokyo, October 12, 2003
Entering in force on October 30, 2003!
On May 20, 2003 with the Notification No. 20 the Minister of Health, Labor and Welfare of Japan set forth the Standards for Raw Materials Originating from Living Organisms - a key regulatory document of the Japanese regulatory affairs, reflecting the amendments related to the both medicines (pharmaceuticals and biologicals) and medical devices.
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MHLW/PFSB Notification No. 0520004 specified the the amended details of the cGMP regulations including the newly set forth terms for retaining the records and the samples.
IMPORTANT: HELP FOR USING JK DOCUMENT STORE
JK Services operates two web sites dedicated exclusively to the Japanese pharma regulatory affairs:
1. JKS Web site (www.jouhoukoukai.com) - containing free data and information available for all visitors, including the Japan Approval Database - the only database in English of all medicinal products approved in Japan in the past 5 years.
2. JKS Document Store -
(https://www.jouhoukoukai.com/Merchant2/merchant.mvc?Screen=SFNT&Store_Code=JS+) where customers could purchase online documents related to the Japanese regulatory affairs. Offered are the following 5 types of documents:
The entire store could be browsed by using the left-side menu. Click here to visit the store.
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