Development of Orphan Drugs in Japan: Effects of a Support System for Development of Orphan Drugs in Japan
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Drug informarion Journal, Vol. 34. pp. 829-837, ZOO0 Printed in the USA. All rights reserved.
DEVELOPMENT OF ORPHAN DRUGS IN JAPAN: EFFECTS OF A SUPPORT SYSTEM FOR DEVELOPMENT OF ORPHAN DRUGS IN JAPAN* MAKOTO SHIRAGAMI, PHD Director, Compliance Review Department, The Organization for Pharmaceutical Safety and Research, Tokyo, Japan
KIYOHITO NAKAI Deputy-Director, Blood and Blood Products Division, Pharmaceutical and Medical Safety Bureau, Ministry of Health and Welfare, Tokyo, Japan
In order to promote development of orphan drugs, the Japanese Ministry of Health and Welfare introduced support measures for drug development in 1985 and 1993. To see if these support measures were really effective for drug development, we compared the number of orphan drugs and review periods required for their approval in three different periods. The number of approved drugs in a year of Term 3 (after 1993) was upproximately 3.3 times that of Term 1 (before 1985). The median value of the review period required for approval of drugs in Term 3 was 15.5 months, shorter than that in Term 1 by 10.5 months. It was clearly shown that the number of drugs developed was increased and the review period was significantly reduced because of the support measures. Now it is possible for patients suffering from orphan diseases to get access to new and more effective drugs sooner Key Words: Orphan drug; Support system for orphan drugs; Approval of orphan drugs; Review period
INTRODUCTION TO PROMOTE DEVELOPMENT of SOcalled orphan drugs, the Japanese Ministry of Health and Welfare issued a Pharmaceutical Affairs Bureau Notification in June 1985 and
Reprint address: Dr. Makoto Shiragami, Compliance Review Department, The Organization for Pharmaceutical Safety and Research, 9" Floor, Shin-Kasumigaseh Building 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-001 3, Japan. *The views expressed in this article are solely those of the authors, and official endorsement by the Ministry of Health and Welfare or The Organization for Pharmaceutical Safety and Research should not be inferred.
introduced support measures (1). The notification mainly simplified the documents attached including allowing stability documents to be submitted later and providing flexibility in operation of requirements on acceptance of foreign clinical data. Then, in April 1994, the Pharmaceutical Law was amended to start new support measures effective in October 1994 (2): 1. Grants-in-aid: Research expenses are subsidized. These expenses were approximately $1 10,000 (12 million-yen) on average for each compound from 1993 to 1998. These grants covered less than one half of
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Mukoto Shiragami und Kiyohito Nukai
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the total expenses of the research activities and provided a subsidy for three years in principle, 2. Tax deduction. Taxation is deductible for research expenses in development of orphan drugs at 6% of the expenses, excluding the grant-in-aid when it is less than 10% of the corporate tax.
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