Scrip is part of the Business Intelligence Division 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

UsernamePublicRestriction
UsernamePublicRestriction

MHLW Relied On EU and U.S. For Actos Safety Data, But Newly Funded Health Records Database Will Boost Japan's Pharmacovigilance

This article was originally published in PharmAsia News

Executive Summary

TOKYO - Japan's Ministry of Health, Labor and Welfare followed the lead of EMA and U.S. FDA and requested Takeda Pharmaceutical Co. Ltd. to change labeling for Actos (pioglitazone) to reflect safety concerns about the risk of bladder cancer. MHLW had to rely on epidemiological data compiled by EMA, but MHLW's safety division hopes new funding from the government will help build an electronic health records database to conduct similar pharmacovigilance epidemiology studies for the Japanese market
Advertisement

Related Content

Japanese Government to Tackle Preventative Health Care Using Big Data
Rethinking Sources Of Innovation In Asia As The “Pendulum Swings Back” To Japan – BIO Asia
Japan's Generic Market Primed For Growth, But Distribution And Manufacturing Barriers Remain
Revisions To Japan Pharmaceutical Affairs Law On The Table For Internal Watchdog Agency
Revisions To Japan Pharmaceutical Affairs Law On The Table For Internal Watchdog Agency
EU's CHMP Delays Decision On Actos, Restricts Use Of An NSAID And Cytoprotective
EU's CHMP Delays Decision On Actos, Restricts Use Of An NSAID And Cytoprotective
Japan To Pass Bill For Special Economic Zones To Boost Foreign Investment And Consumer Confidence
Advertisement
UsernamePublicRestriction

Register

SC078339

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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

Cancel