Jouhou Koukai Publishing, a Jouhou Koukai business

Jouhou Koukai Announces Japan Master Files Database and JKS Milestone document

TOKYO, August 8, 2006
 

Jouhou Koukai Publishing, a JKS business, today announces the simultaneous release of two new additions to the Japan Approvals Database (JAD) and to the JKS Documents collection. 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 shown in the screenshot and 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.

Additional product and subscription information about the new offers is available from the JKS web site:

• for introduction http://www.jouhoukoukai.com/disclosed/jad_intro.htm

• pre-subscription orientation - http://www.jouhoukoukai.com/members/subscription_details.htm

• to subscribe - https://id3410.securedata.net/jouhoukoukai/members/subscription_form.htm

• complete Table of Contents of “Japan Master Files – Overview” is available at http://www.jouhoukoukai.com/Merchant2/merchant.mvc?Screen=PROD&Product_Code=7_D_M001&Category_Code=7M

• JKS Documents Store - http://www.jouhoukoukai.com/Merchant2/merchant.mvc?Screen=SFNT&Store_Code=JS

The JAD Databases are accessible only by the registered subscribers. For browsing all documents and reports published by Jouhou Koukai Publishing, please visit the JKS Documents Store.

About Jouhou Koukai Services

Jouhou Koukai Services LLC and its business Jouhou Koukai Publishing is a leading provider of English-language information products and services to professional end users in regulatory, scientific, pharma, business and intellectual property (IP) information markets. The Company offers databases, intelligence, and services such as electronic publishing, document delivery and market research with focus on the Japanese life sciences and medicinal products industries primarily to the regulatory, executive, business development, licensing, IP, IT (including e-health), research and medical communication professionals worldwide.

Media contact:
Tel: +81-367-174-195 / pr_jks(at)jouhoukoukai.com
Subscribers inquires: orders(at)jouhoukoukai.com
 

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