The review of new drug applications in Japan: The decline in approval times after the introduction of an internalized review system

Drug Information Journal

Volumn 39, Issue 3, 2005, Pages 279-290

  Ono, Shunsuke ^a,c   Yoshioka, Chisato ^a   Asaka, Orie ^b   Tamura, Koji ^b  

^a KANAZAWA UNIVERSITY   (Japan)

^b Japan Pharmaceutical Manufacturers Association   (Japan)

^c PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

Author keywords

Approval times; Japan: Pharmaceuticals and Medical Devices Evaluation Center; New Drug Application (NDA); Reviewing agency

Indexed keywords

NEW DRUG;

DRUG APPROVAL; DRUG INDUSTRY; DRUG RESEARCH; EUROPEAN UNION; JAPAN; PRIORITY JOURNAL; REVIEW; UNITED STATES;

EID: 23844484145     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150503900306     Document Type: Review

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