PMDA's Medical Information Project To Improve Adverse Effect Data In Japan
This article was originally published in PharmAsia News
PMDA's project for developing a medical information database infrastructure for 10 million people aims to better understand the probability for adverse effects with drugs and will enter its test period starting next year.
You may also be interested in...
Known as PROMPT, the prospective monitoring system might be useful in tracking a new drug that is part of a category in which a safety issue has arisen before, or in cases where potential problems surfaced in development studies, according to researchers.
The Japanese government has decided to revise its drug pricing policies starting in April 2014. Changes include extending a price premium program for two more years, bundling the pricing of similar generic drugs, and reduced pricing on long-listed drugs.
New rules separate medical devices from pharma regulations to provide clarity and regulatory efficiency, removing approval hurdles for devices and software in 2014.