Japan's MHLW Approves Request For Needed Drugs That Can Bypass Clinical Trials
This article was originally published in PharmAsia News
Executive Summary
TOKYO - Japan's Ministry of Health, Labor and Welfare is urging manufacturers to develop drugs for Japan that are still unapproved or unapproved for additional indications already approved in the West. Some drugs considered highly medically necessary may qualify for approval via a known-art application without conducting new clinical trials in Japan. The move is part of the ministry's ongoing efforts to reduce the country's much talked about drug lag