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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Related document:

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.



JK Services operates two web sites dedicated exclusively to the Japanese pharma regulatory affairs:

 1. JKS Web site ( - 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 -

( where customers could purchase online documents related to the Japanese regulatory affairs. Offered are the following 5 types of documents:

  a) Milestone documents - containing full description of certain step of the product development in Japan - e.g. the recent "Japanese CTD" ( provides information about the status of CTD in Japan as of September 2003. (Other coming documents of the Milestone series are focused on GMP, GCP and intellectual property in pharma).
  b) Key documents - translated important notifications from Japanese authorities such as on quality control of products containing materials from human or animal origin (
  c) Background documents - such as those on MRA or WTO (
  d) Notification Lists - the only available in English monthly list of all ordinances, notifications, etc. issued by the Japanese authorities (
  e) Legal documents - selected texts of laws and agreements related to the pharma in Japan. (
The entire store could be browsed by using the left-side menu. Click here to visit the store.

Enquiries: regulatory(at)

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