Pushing to speed its historic lag in drug approval times compared with the United States and the European Union, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is bolstering the ranks of its product review staff and making major changes in its approval processes.
The changes include establishing a system for the conditional early approval of novel and life-saving therapies, allowing submission of data on a rolling basis, speeding approval pathways, and strengthening the monitoring of new drugs after they are approved.
Approving new drugs faster, while still ensuring safety and efficacy, would allow Japan to bring more new therapies to patients faster. The “drug lag” issue has been a major point of concern among regulators in Japan for years. Improvements have been made, but approvals of psychiatric, therapeutic, and neurological drugs in particular still remain slow, according to the PMDA.