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Jouhou Koukai Announces Japan Master Files Database and JKS Milestone document
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
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.
Tel: +81-367-174-195 / pr_jks(at)jouhoukoukai.com
Subscribers inquires: orders(at)jouhoukoukai.com
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to the only English-language database of approved pharma products in Japan.
This is a CAN-SPAM compliant service email. Jouhou Koukai Editorial office is located at Shinagawa Intercity Tower A, 28F, Konan 2-15-1, Minato-ku, Tokyo 108-6028, Japan. Send further inquiries to pr_jks(at)jouhoukoukai.com. c Copyright 2006 by Jouhou Koukai Services LLC. All rights reserved.