Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


MHLW To Erase Drug Lag By 2011 And Oppose Reference Price System

This article was originally published in PharmAsia News

Executive Summary

Japan's Ministry of Health, Labor and Welfare issued a report Aug. 12 on measures to erase the Japanese drug lag and promote generic drug use. In the report, the Ministry set a goal of erasing the drug lag by 2011. To reach this goal, the MHLW plans to increase the number of reviewing staff and improve its Good Clinical Practice operations. However, the Ministry denies that it will significantly relax approval regulations on new drugs that have already been approved in the U.S. and Europe. According to the Ministry, a sufficient approval reviewing process is needed as ethnic differences exist, such as Japanese need lower dosages and show more severe adverse effects compared to Europeans and Americans. In generic drugs use, the Ministry also declined to introduce a reference price system, in which insurance reimbursements prices for the brand and for generic drugs are kept the same when the patent for a branded drug expires. (Click here for more - Japanese language

Related Content




Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts