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Development of Orphan Drugs in Japan: Effects of a Support System for Development of Orphan Drugs in Japan

  • Makoto Shiragami
  • Kiyohito Nakai
Article

Abstract

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 approximately 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 

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Copyright information

© Drug Information Association, Inc 2000

Authors and Affiliations

  • Makoto Shiragami
    • 1
  • Kiyohito Nakai
    • 2
  1. 1.Compliance Review DepartmentThe Organization for Pharmaceutical Safety and ResearchTokyoJapan
  2. 2.Blood and Blood Products Division, Pharmaceutical and Medical Safety BureauMinistry of Health and WelfareTokyoJapan

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