The measurement of stringency of pharmaceutical regulations across nations

Abstract

The objective of this study is to evaluate the degree of stringency of three pharmaceutical regulatory controls in nine developed countries. A mail survey was conducted among pharmaceutical executives to assess their attitudes toward the impact of regulatory items on the new drug development and introduction. These regulatory items were withdrawn from year-specific individual country regulatory profiles. A multi-attribute attitude model was then employed to construct the index during the study period. The results of this study can be useful in evaluating the regulatory impact on the pharmaceutical research and development productivity and rate of new drug introduction across the nations.