Moving to ensure patients can access innovative drugs and medical devices faster, Japan’s Ministry of Health, Labor and Welfare (MHLW) plans to amend the nation’s health and safety laws to speed the development of a fast-track review process.
The scope of the amendments is not expected to be finalized before the end of 2019 but may bolster solid legal backing for conditional early approvals of drugs currently regulated only by health ministry notifications.
The MHLW also plans to mandate fines on drug companies for improperly earned revenues, clarify safety procedures for clinical trials and boost other safety measures.