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
You may also be interested in...
Could Japan's Chuikyo Embrace NICE Model As New Chairman Takes Reign?
The new chairman of Japan's Central Social Medical Insurance Council (Chuikyo), the committee that determines drug pricing for Japan's National Health Insurance, will consider the possibility of linking drug pricing to health technology assessments, similar to the UK's National Institute for Health and Clinical Excellence
Could Japan's Chuikyo Embrace NICE Model As New Chairman Takes Reign?
The new chairman of Japan's Central Social Medical Insurance Council (Chuikyo), the committee that determines drug pricing for Japan's National Health Insurance, will consider the possibility of linking drug pricing to health technology assessments, similar to the UK's National Institute for Health and Clinical Excellence
PMDA Cuts Review Lag With West In Half, But Application Lag Shows No Relief For Drug Launches In Japan
TOKYO - Japan's Pharmaceuticals and Medical Devices Agency has reduced its drug review lag in half since rolling out a plan two years ago to cut the drug lag, but products launched in the U.S. still hold a two-year head start compared to products launches in Japan, according to new estimates released by Japan's drug regulatory agency