The Review of New Drug Applications in Japan: The Decline in Approval Times after the Introduction of an Internalized Re
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Shmsrke Ono, PhD Associate Professor, Faculty of Pharmaceutical Sciences, Kanazawa University, Kanazawa, Japan Chisoto Yoshioko, MS Graduate Student, Faculty of PharmaceuticalSciences, Kanazawa University, Kanazawa, Japan Orie Asoko, PhD Research Fellow. Office of PharmaceuticalIndustry Research. Japan Pharmaceutical Manufacturers Association, Tokyo, Japan Koji Tonuro, MS Research Fellow. Office of PharmaceuticalIndustry Research, Japan Pharmaceutical Manufacturers Association, Tokyo, Japan
Key Words Japan; Pharmaceuticalsand Medical Devices Evaluation Center; New Drug Application (NDA): Approval times; Reviewing agency This article was presented in part at the 40th DIA Annual Meeting in Washington. D.C. in June 2003.
Correspondence Address Shunsuke Ono. PhD, Pharmaceuticalsand Medical Devices Agency. 3-3-2 Kasumigaseki, Tokyo, 100-0013, Japan (e-mail: [email protected]).
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The Review of New Drug Applications in Japan: The Decline in Approval Times After the Introduction of an Internalized Review System The approval time is defined as the time between the submission date and the approval date and is a regulatory performance meusure commonly used in internationalcomparisons. TheJapanese office of Pharmaceutical Industry Research conducted a survey in 2003 to cdl& unpublished data on approval times of recently approved new drugs in Japan. The results of the survey, which targeted 315 new drug applications (NDAS) approved beiween 1996 and 2002, showed that the Japanese median approval times were reduced signijiuantly j b m
BACKGROUND-THE JAPANESE N EW D R U G A P P L l CAT1 0 N R E V 1 EW SYSTEM International harmonization in pharmaceutical research and development (R&D) has progressed rapidly in both the private and public sectors. The activities of the International Conference on Harmonisation (ICH) that started with the governments and the pharmaceutical industries in the European Union, the United States, and Japan are now expanding to other regions of the world. Although such harmonization trends help to achieve efficiency in pharmaceutical R&D, the New Drug Application (NDA) review system in each country (or region) itself is not expected to be harmonized soon because it is apparently a product of complicated regional factors, including the medical needs in specific environments, political history, and cultural backgrounds. The Japanese new drug approval system has some unique characteristics that are rooted in historical governmental review policies (1,2). Before the establishment of the Pharmaceuticals and Medical Devices Evaluation Center in 1997, human resources available for NDA review in the regulatory agency were very limited.
41.3 months in 1998 to I27 months in 2002 ly an approval cohort analysis. When compared with approval times in other countries, Japanese approval times have been gmdually approaching those in the United States and the European Union, espm*a& since the establishment of a new review agency in 3992 The redudion in approval times seemed to be achieved by internalizing the review
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