FORUM

New Policy on the Utilization of Foreign Clinical Data and Our Future Task

Abstract

A new policy on the utilization of foreign clinical data was adopted by the Ministry of Health and Welfare in the summer of 1998. It is based on the ICH Guideline, an international agreement, that was achieved through a lengthy process. Now many pharmaceutical companies will be forced to drastically reexamine their new drug development strategies.
The guideline emphasizes that the influence of intrinsic and extrinsic ethnic factors on the drug's efficacy and safety should be evaluated through the development process. And in most cases, sponsors need to conduct a “bridging study” to determine whether or not the foreign clinical data can be extrapolated to the domestic population. “Bridging studies” can be classified roughly into the following three categories, 1) no need for bridging study, 2) controlled pharmacodynamic study, and 3) controlled clinical study. Among these categories a dose-response study using a clinical endpoint could be recommended as a bridging study for the time being.
In order to render the guideline meaningful, and the new drug development more efficient, further discussion is needed on the appropriate method or way of thinking of (1) assessing the pharmacokinetic profile, (2) deciding the sample size of the bridging study and evaluating its similarity to the foreign data, and (3) conducting post marketing surveillance for drugs approved mainly based on foreign clinical data.