MHLW Considers Extending Postmarketing Evaluation Period
This article was originally published in PharmAsia News
Executive Summary
Japan's Ministry of Health, Labor and Welfare is considering extending the postmarketing surveillance period for new drugs requiring more careful handling, such as cancer drugs. The MHLW currently monitors adverse events for new drugs for a six-month postmarketing period; a safety team is considering more flexible measures, including extending the check period or the ability to extend evaluations in the middle of a check period. (Click here for more - Japanese language