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Japan Approvals Database (JAD)
Master File + Master Files Overview

  • Publication Date:August 2006
  • Publisher:Jouhou Koukai
  • Product Type: Online Subscription

Japan Approvals Database (JAD) Master File + Master Files Overview

Japan Approvals Database, JAD (ISSN 1550-3399) is the leading English-language database containing key information on over 600 new drugs (pharmaceuticals, biologicals, combination products, contrast media and radiopharmaceuticals) approved in Japan from 1999 to August 2006. Along with the updates of the core JAD Database, starting in Q3/2006 several Extended Databases are scheduled to be added for enhancing the research and information value of JAD. The first of the JAD Extended Databases - JAD Japan Master Files (JAD-MF) contains data for all 1,647 Drug Master Files registered in Japan since the MF system introduction in April 2005, arranged in 12 categories as in the list below:

  1. Serial number - the consecutive number of the entries, at present up to 1,647
  2. Registration number
  3. Registration date
  4. Registrant name
  5. Alternative name
  6. Registrant address
  7. Registration item
  8. Registration update
  9. Registration classification
  10. JAD ID Number - JAD Identification Number
  11. Status
  12. Remarks - such as JAD Entity references (related to manufacturers), etc.

As a companion to the JAD-MF Database published simultaneously is the 82-page JKS Milestone document entitled "Japan Master Files - Overview" - the only and fullest up-to-date English-language description of the basics of the Master File system as implemented in Japan. Translated are excerpts from the Pharmaceutical Affairs Law (PAL) of Japan and key notifications from the Ministry of Health, Labor and Welfare (MHLW). Illustrated representation of the Master Files system is provided, along with the details of registration procedure, the Governmental entities responsible for MF handling and the sample forms used for submission. Research and use of the document is aided by the inclusion of complete references and numerous annotations to help novices to Japanese pharmaceutical regulations.

The newly added JAD Japan Master Files Database and "Japan Master Files - Overview" follow the radical reform of the Japanese pharmaceutical affairs bringing considerable - and previously not permitted opportunities for the foreign pharmaceutical developers, manufacturers and distributors to enter and expand in Japan. As the second largest single country pharma market in the world Japan has always been attractive for overseas entrants in spite of regulatory, trade and linguistics barriers. Dedicated to supporting all new players in the Japanese pharmaceutical market, now by introducing the English-language JAD Japan Master Files Database paired with "Japan Master Files - Overview", JKS Publishing further facilitates the entry of a wide range of bulk substances and active pharmaceutical ingredients makers from around the world, including the emerging pharma markets of India, China and Korea.

  • Features
    • - The JAD database contains data on the medicinal products approved in Japan by the Ministry of Health, Labor and Welfare for a 8th year - from 1999 to present. The latest issue of the JAD is for August 2006.
    • - There are four categories of regulated medicinal products in Japan: drugs, medical devices, quasi-drugs and cosmetics. The JAD database contains data on "drugs" category - pharmaceutical, biologicals, contrast media, radiopharmaceuticals and combination products.
    • - The medicinal products are approved by the Japanese pharmaceutical regulatory authorities in four rounds annually: January, April, July and October. The new issues of the JAD follow the same pattern. The new data are added to the database within a week after the approval.
    • - The entry for each entry of the database contains the following information: maker/importer, brand name, generic name, formulation, packaging, doses, name of generics variants, co-marketer/co-promoters, availability of package insert (PI), approval review (AR), regulatory category (RC) and Summary Basis of Approval (SBA), and comments (if applicable).
    • - The JAD is searchable in two different ways: from the search engine of the JKS Group web sites - available for all users and visitors, and from the JAD-only search facility - available only to the JAD subscribers.
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