14
Understanding Drug Development and Registration in Japan
W. J. C. Currie
Merck & Co., Inc.
Rahway, New Jersey
I. Introduction
353
II. The Regulatory Process
354
III. Quality Needs
361
IV. Preclinical Needs
362
V. Clinical Needs
367
VI. Other Issues
372
References
374
I. Introduction
The sales of pharmaceuticals in Japan, in United States dollar terms, are second only to those in the United States [1]. The significant price reductions occurring in the developing managed-care environment of the United States and the strength of the yen are likely to reduce the U.S. lead. Thus it is not surprising that U.S. pharmaceutical companies are eager to register and sell their drugs in Japan. Differences in the regulatory requirements that have been noted between these two countries have been viewed as barriers to free and fair trading in pharmaceuticals. These issues are not new, and to resolve them
