Current Status of Clinical Trials and Good Clinical Practice in Japan
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Drug Informotion lournal, Vol. 31, pp. 1071-1078, 1997 Printed in the USA. All rights reserved.
Copyright 0 1997 Drug Information Association Inc.
CURRENT STATUS OF CLINICAL TRIALS AND GOOD CLINICAL PRACTICE IN JAPAN TOSHIYOSHI TOMINAGA, PHD Pharmaceutical and Cosmetic Division, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, Tokyo, Japan
This paper highlights the characteristic features of the Japanese good clinical practice and the Japanese clinical trial system. It also discusses the ongoing reform of the system, including the revision of the Pharmaceutical Affairs Law and substitute ordinances. Key Words: Good clinical practice; Japan; Clinical trials
ment. The MHW then reviews the drug application. But a substantial part of the review The Japanese Drug Market is relegated to the Central Pharmaceutical JAPAN’S SHARE OF THE world drug mar- Affairs Council, which is an independent deket accounts for a substantial portion, that liberating council outside the MHW but esis, 22%, of the $200 billion world drug mar- tablished under the Pharmaceutical Affairs ket (see Figure l). Per capita GNP is $3 1,450. Law. This council makes a report of its evaluLike most developed countries, Japan is hav- ation and submits it to the Minister of Health ing difficulty suppressing its medical expen- and Welfare. Depending on the report, the ditures, which account for more than 5% of Minister approves the drug. In its review of its GNP. Out of this 5% figure, 30% is spent the drug applications, MHW gets necessary on drugs. From these statistics, one can gauge technical assistance from the National Instithe substantial number of new drug applica- tute of Health and the National Institute of tions that the Ministry of Health and Welfare Hygienic Sciences. (MHW) handles each year.
INTRODUCTION
Status of New Drugs Approved in Japan
The Drug Approval System in Japan Figure 2 outlines the mechanism for new drug approval in Japan. Under the current system, a drug company files an application to the MHW through the prefectural govern-
Presented at the DIA Workshop “Clinical Trials and GCP in East Asia.” July 7, 1996, Tokyo, Japan. Reprint address: Dr. Toshiyoshi Tominaga, Pharmaceutical and Cosmetic Division, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, 1-2-2, Kasumiga-seki, Chiyooa-ku, Tokyo 100, Japan.
The number of new drugs approved in Japan from 1990 to 1995 is shown in Figure 3. On average, the number of new drugs approved each year is about 30-40.About half of these new drugs are developed in Japan and half are introduced from abroad. The number of new drug applications (not shown in the figure) is about 40-60.(It should be noted that this figure varies each year.) For each year, therefore, about 20 or more of these new drug applications are not approved.
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Toshiyoshi Tominaga
JAPAN’S MARKET GNP: $4,300 billion Medical Expenses: $222.5 billion (5.17% of GNP)
Drug Ratio:
- 30%
FIGURE 1. The world drug market: $199 billion in 1993.
Acceptance of Foreign Clinical Data Basically,
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