PMDA's challenge to accelerate clinical development and review of new drugs in Japan.

ABSTRACT

In recent years, Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has conducted several projects to shorten drug development and review times in Japan to resolve the "drug lag." Key to achieving this goal is greater involvement by the PMDA in drug development through enhancement of scientific consultation and improvement of the review process by reinforcing the operational system, including hiring more reviewers. We discuss here the current projects of the PMDA as well as future challenges.