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Volumn 34, Issue 3, 2000, Pages 829-837

Development of orphan drugs in Japan: Effects of a support system for development of orphan drugs in Japan

Author keywords

Approval of orphan drugs; Orphan drug; Review period; Support system for orphan drugs

Indexed keywords

ORPHAN DRUG;

EID: 0033846973     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150003400319     Document Type: Article
Times cited : (8)

References (10)
  • 1
    • 0008181554 scopus 로고
    • Notification No. 2. Notification of Director of Pharmaceuticals and Cosmetics Division I, Director of Safety Division and Director of Biologics and Antibiotics Division, Pharmaceutical Affairs Bureau, MHW, Data should be attached in case of Application for manufacturing and import of orphan drug
    • (1985)
  • 4
    • 0008188156 scopus 로고    scopus 로고
    • Medical Economics Division, Health Insurance Bureau, MHW ed. NHI Drug Price System. Tokyo: The Yakujinippo Limited
    • (1998) , pp. 88
  • 5
    • 0008228847 scopus 로고
    • Development promotion measure of orphan drugs newly introduced
    • (1993) Bio Tech , vol.7 , pp. 206
    • Ueki, A.1
  • 6
    • 0008266770 scopus 로고    scopus 로고
    • Research Division, Pharmaceutical and Medical Bureau, MHW (supervised). Guideline for Drug Manufacture. 1997 edition. Tokyo: Jiho, Inc.
    • (1997) , pp. 582-632
  • 7
    • 0008182112 scopus 로고    scopus 로고
    • Research and Development Division, Pharmaceutical Affairs Bureau, MHW (supervised). Handbook of Orphan Drugs, Second edition. Tokyo: Jiho, Inc.
    • (1996) , pp. 3-17
  • 8
    • 0008183158 scopus 로고    scopus 로고
    • Organization for Pharmaceutical Safety and Research ed. Orphan Drug Development Promotion System. Tokyo, Organization for Pharmaceutical Safety and Research
    • (1999)
  • 10
    • 0008280689 scopus 로고    scopus 로고
    • Evidence by the Chairman of Pharmaceutical Research and Manufacturers of America in Budget Committee of the US Senate, PhRMA Statement
    • (1998)
    • Holmer, A.F.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.