Jouhou Koukai Services LLC



New in JKS Document Store


Tokyo, September 9, 2003


JK Services is making for first time available in English the full translation of a key regulatory document related to the Japanese GMP. Upon the adoption in May 2003 of the "Standards for Raw Materials Originating from Living Organisms", the presented here MHLW 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, covering both the cases of medicines (pharmaceuticals and biologicals) and medical devices. 28 pages document.

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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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