Pink Sheet 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

UsernamePublicRestriction
UsernamePublicRestriction

Japan’s PMDA Adds ‘Safety Net’ Initiative To Resolve Drug Lag: An Interview With PMDA (part 2 of 2)

This article was originally published in The Pink Sheet Daily

Executive Summary

In part 2 of this series, Kaoru Misawa outlines PMDA’s intentions for the initiative and industry reaction in Japan.

You may also be interested in...



Japan Launches ‘Safety Net’ Initiative As PMDA Looks To Resolve Drug Lag With The West (Part 1 of 2)

TOKYO - Japan's Pharmaceuticals and Medical Devices Agency has started a new pilot program for risk management, tentatively being called the "product management" initiative. Under the initiative, a group will be created within PMDA's Office of Safety to oversee a new drug throughout its life cycle. Initial plans called for only a handful of drugs being involved. The agency hopes to finish the pilot program within six months, in time for the initiative to be operational some time in the spring

Japan’s 2014 Drug Price Reforms Extend Price Premium Program

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.

Revised Rules For Japan’s Medical Devices Could Mean Speedier Time To Market

New rules separate medical devices from pharma regulations to provide clarity and regulatory efficiency, removing approval hurdles for devices and software in 2014.

Topics

UsernamePublicRestriction

Register

LL029263

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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