Generic / Small Molecule / Compliance Management

Novartis Japan Faces Censure for Reporting Delays

Nov 11, 2015

The Japan Times

According to an article in The Japan Times, the Ministry of Health, Labor and Welfare will censure a Japanese unit of Novartis AG for failing to report serious drug side effects.

The health ministry could serve Novartis Pharma K.K. with a business improvement order this month, the article said.

The case involves side effects from about 5,500 patients, which should have been reported within a few weeks. Read the full story