Academic Clinical Trials and Drug Regulations in Japan: Impacts of Introducing the Investigational New Drug System

Therapeutic Innovation & Regulatory Science
Hisashi Urushihara, Koji Kawakami

Abstract

In Japan, academic clinical trials do not generally need to be conducted under good clinical practice and cannot therefore be used for regulatory submission for marketing authorization of new medical products. We reviewed 2 differential regulatory systems governing clinical trials in Japan and the development histories of 2 case products whose clinical trials at the early development stage were conducted by academic researchers and transferred to the private sector for further development toward commercialization in Japan. We further estimated that the introduction of the investigational new drug system may have accelerated the development of tocilizumab, an antibody drug for rheumatoid arthritis, at best by 2 years by utilizing the results of early exploratory clinical trials conducted by academic investigators. Similarly, an enlarged indication for JACE®, a cultured epithelium autograft for severe burns, would have been expected at launch by utilizing the results of academic trials investigating various indications. These possible impacts and estimations would warrant introducing the investigational new drug system into Japan drug regulatory system.

References

Sep 1, 1995·The Journal of Burn Care & Rehabilitation·K MatsuzakiH Ishida
Jul 1, 1997·Annals of Plastic Surgery·N Kumagai, T Uchikoshi
Apr 26, 2000·European Journal of Human Genetics : EJHG·J M van den OuwelandJ A Maassen
Mar 10, 2001·Clinical Immunology : the Official Journal of the Clinical Immunology Society·M MiharaY Takeda
Mar 4, 2006·BMJ : British Medical Journal·Akseli Hemminki, Pirkko-Liisa Kellokumpu-Lehtinen
Jan 11, 2007·Journal of Burn Care & Research : Official Publication of the American Burn Association·Gary F Purdue
Apr 5, 2007·European Journal of Pediatric Surgery : Official Journal of Austrian Association of Pediatric Surgery ... [et Al] = Zeitschrift Für Kinderchirurgie·S SuitaK Tatsuta
May 31, 2007·Lancet·Richard Hoey
Apr 9, 2008·Health Policy·Mina TsubouchiKoji Kawakami
Jun 13, 2008·Nature·Kaori Tsuji, Kiichiro Tsutani
Jul 30, 2008·British Journal of Clinical Pharmacology·Hiddo J Lambers HeerspinkDick de Zeeuw
Aug 12, 2008·BioEssays : News and Reviews in Molecular, Cellular and Developmental Biology·Howard Green
Dec 10, 2009·Journal of Orofacial Orthopedics = Fortschritte Der Kieferorthopädie : Organ/official Journal Deutsche Gesellschaft Für Kieferorthopädie·Eva MüssigThorsten Steinberg
Mar 2, 2010·Nature Reviews. Clinical Oncology·Chiyo K ImamuraNaoto T Ueno
Aug 24, 2010·Clinical Trials : Journal of the Society for Clinical Trials·James D NeatonJens Lundgren
Oct 30, 2010·Nature Reviews. Drug Discovery·Robert Kneller

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