Recent Approaches by the PMDA to Promoting New Drug Development: Change in the Status of the PMDA in Relation to New Dru
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Recent Approaches by the PMDA to Promoting New Drug Development: Change in the Status of the PMDA in Relation to New Drug Development Over the Last Five Years Kazrhiko Mori, MS Associate Center Director. Center for Product Evaluation. Pharmaceuticals and Medical Devices Agency. Tokyo. japan; Director of Safety Division, Pharmaceutical and Food Safety Bureau, Ministry of Health. Labour and Welfare. lapan
Satoshi Toyorhima, PhD Executive Director and Director. Center for Product Evaluation. Pharmaceuticals and Medical Devices Agency, Tokyo. japan
The numbcrs of dinical trial consulMions and approved NDAs in FY2W increased more than 5m comprad with FY2004, when the ilhcd PMDA was cstabs The stmtegy of new drug development has changed signijicantly; in partidar, simultaneous global development has accelemted dmmatically in Asia, except in Japan. Based on this situation, the PMDA and MHLW clarified their intention to encoumge the phannaceutical industry to conduct multinational clinical trials from the early stage of clinical develop-
Key Words japan; Pharmaceuticals and Medical Devices Agency (PMDA): Global development; Multinational clinical trial: Drug lag
Correspondence Address Kazuhiko Mori. MS. Ministry ofHealth. Labour and Welfare. 1-2-2 Kasumigaseki, ToAyo, 1008916. japan (email: morikazuhiko@ m hlw.go.jp) .
INTRODUCTION The Pharmaceuticals and Medical Devices Agency (PMDA) was established in April 2004 as an independent administrative agency by consolidating the services of three organizations: the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC), the Organization for Pharmaceutical Safety and Research (OPSR), and the Japan Association for the Advancement of Medical Equipment. In this report, we present a retrospective review of how the PMDA has addressed issues related to new drug development by offering review of New Drug Applications (NDAs) and clinical trial consultations during the five years since its establishment. The objective of the PMDA is "to contribute to improvement of public health through promoting prompt provision of more effective and safer pharmaceuticals and medical devices to patients" (1). To attain this objective, the level of clinical development of new pharmaceuticals in japan has to be raised to a level comparable to that in Europe or the United States by improving the
ment in September 2 W . As a result, the number of mdtinatimd clinical trials including Japanbegan to increase quic&. With regavd to the review time of NDAs, it still takes longer than that of FDA or EMU. Although the situation has begun to improve, the PMDA still needs to furthershorten it. The PMDA initiated a new plan starting in April 2007 to add more than 200 reviewers within a period of approximately three years in order to resolve the issue of drug lag.
processes involved in ensuring efficacy and safety of drugs and also ensuring efficient and speedy drug development. Toward this end, it is important for pharmaceutical companies to hold active discussions with the PMDA on various relevant i
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