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


Japan Regulator Begins Five-Year Program Of Drug-Approval Reforms

This article was originally published in PharmAsia News

Executive Summary

Japan's Pharmaceuticals and Medical Devices Agency has kicked off a five-year program aimed at reducing the time it takes to get a drug to market. The plan also is intended to step up the country's participation in worldwide clinical trials, an increasing trend in the pharmaceutical industry. PMDA also has a pilot program consisting of a scientific consultation for companies to use before they submit applications for approval of new drugs. The pre-review consultation is designed to occur during Phase III trials. (Click here for more

You may also be interested in...

Japan's Clinical Trial Costs Average ¥2 Million; Number Of Trials On The Rise

TOKYO - The number of clinical trials being performed in Japan is trending upward every year, but trial costs fluctuate sharply from year to year, according to survey results released by Japan's Pharmaceutical Manufacturers Association

QUOTED. 3 June 2020. Stephen Hahn.

In a 1 June speech before the Alliance For a Stronger FDA, US FDA commissioner Stephen Hahn stressed the agency’s vigilance in guarding against consumer use of flawed COVID-19 products. He also made comments about the need for doctors to communicate more with patients. See what he said about the use of telehealth here.

House Committees Want BARDA Coronavirus Vaccine, Treatment Contract Info

Request for documents and a briefing is part of efforts to ensure federal programs are ‘protected from price gouging.’




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