Jouhou Koukai Publishing, a JKS business, has announced 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 an English-language database containing 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, including: Serial number, the consecutive number of the entries; Registration number; Registration date; Registrant name; Alternative name; Registrant address; Registration item; Registration update; Registration classification; JAD ID Number--JAD Identification Number; Status; and 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," an 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 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 JAD Databases are accessible only by the registered subscribers.