by Naveen kumar | Sep 19, 2024
The Sakigake Designation is an innovative program by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), designed to fast-track the development and approval of breakthrough medical products. “Sakigake” translates to “forerunner” or...
by Naveen kumar | Sep 19, 2024
Japan’s new drug approval process is managed by the Pharmaceuticals and Medical Devices Agency (PMDA), which works under the Ministry of Health, Labour, and Welfare (MHLW). Here’s an overview of how a drug gets approved in Japan: 1. Preclinical Testing...
by Naveen kumar | Jun 2, 2024
How orphan drug designation is given in Japan In the previous articles we have studied orphan drugs and now we are going to learn about how orphan drug designation is given in Japan, we are going to discuss how and what are the laws guiding orphan drug designation in...
