by Naveen kumar | Sep 19, 2024
Japan Regulatory Authorities for Drug Approval: A Comprehensive Overview Navigating the complex landscape of drug approval in Japan requires a keen understanding of its regulatory authorities and processes. Japan’s commitment to ensuring the safety and efficacy...
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 | May 24, 2024
Drug Regulatory Authorities of Different Countries Drug regulatory authorities play a vital role in enabling the safety, efficacy, and quality of medicine we take. These authorities involve in overseeing the development, testing, approval, and monitoring of drugs...