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November 18, 2003

Taisho Pharmaceutical Co., Ltd.
Hewlett-Packard Japan, Ltd.


Taisho and HP Japan Create Industry-First Post Marketing Surveillance Support System for Over-the-Counter Drugs
- Strengthening Safeguards for Over-the-Counter Drugs -



Taisho Pharmaceutical Co., Ltd. (President: Akira Uehara) and HP Japan (Hewlett-Packard Japan, Ltd., Headquarters: Tokyo, President: Yasuyuki Higuchi) announce the development and installment of the industry's first post marketing surveillance support system for over-the-counter drug (OTC) , named Taisho OTC PMS-support System (TOPS).

TOPS comprises a safety information management system and a monitor store survey management system. For the precise and rapid management of safety information, the safety information management system supports the electronic reporting (E2B/M2) of side-effects to the Ministry of Health, Labor and Welfare as well as the management of all post marketing safety information, including information from doctors and pharmacists at medical institutions, information from monitor store surveys, information from overseas sources, and information received directly from users.

The monitor store survey management system supports the work processes of monitor store surveys, which are special surveys needed for post marketing analysis of switch OTCs and other products. Monitor store surveys include management of contracts with monitor stores (pharmacies), management of progress on cases of illness, and logical checks on data entry. Data is automatically compiled and written on a variety of forms, considerably improving the efficiency of work processes.

Taisho, ranked number one in OTC sales, and HP Japan, with extensive experience in post marketing surveillance systems for ethical drugs, teamed up to develop the industry's first OTC post marketing surveillance support system that leverages the characteristics of a direct sales pharmaceuticals manufacturer.

More potent OTC medications are being approved as a result of recent liberalization in the industry. Revisions to the Pharmaceutical Business Law have necessitated the accumulation and management of safety information regarding OTC medications on a level as strict as that for ethical drugs (Good Vigilance Practice: GVP). The Ministry of Health, Labor and Welfare now requires companies to report any severe side effects from pharmaceuticals, including OTC medications, through the Pharmaceutical Business Law and Pharmaceutical Regulations. In addition, companies are expected to directly collect information about new OTC medications, including direct OTC and switch OTC products, from users and pharmacies for a specified period after approval. Differing from post marketing surveillances of ethical drugs data collected from doctors and pharmacists at medical institutions, with OTC it is necessary to collect and manage volumes of safety information from a variety of sources, including information from physicians, pharmacists, pharmacists at drug stores, users (including surveys) and overseas sources. These duties are a heavy responsibility for managers in charge of safeguard measures.

By unifying the management of information through the new system, Taisho is able to provide information on the appropriate usage of OTC medications, thereby improving safeguards.

Backed by its long years of experience in the fields of new drug development and clinical trials in the pharmaceuticals industry, HP Japan provides effective systems to pharmaceuticals companies and supports the improvement of safeguards in the pharmaceuticals industry.

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