Japan's MHLW extends review period to 8 years

5 February 2007

Japan's Ministry of Health, Labor and Welfare plans to change the re-examination period for drugs containing new active ingredients from the current six years to eight years in principle.

The Ministry has decided on the change because of concerns over drug safety, following a number of new drug label warning revisions, during the period from five to eight years after approval. A peak at the seventh year after MHLW approval was noted in the number of the revisions by the regulatory body.

The new evaluation period timeframe is due to take effect after clearance from the relevant advisory committees within the MHLW has been obtained.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

More ones to watch >

Today's issue

Company Spotlight

Ironwood is a US-based biotech advancing a pipeline of medicines in multiple areas of significant unmet need, including irritable bowel syndrome with constipation ((IBS-C)/chronic idiopathic constipation (CIC), vascular and fibrotic diseases, and refractory gastroesophageal reflux disease, among others.