As the Chief Executive of PMDA, I will promote “4Fs (First)” listed below:
We make well communication with healthcare professional and work giving the highest priority to patient satisfaction.
We accelerate the access to innovative medical products of public demand, while ensuring appropriate risk-benefit balance.
Focusing on risk mitigation, we implement efficient post-marketing data collection and product distribution control, especially for accelerated approval schemes such as “Conditional Early Approval System” and “SAKIGAKE Designation System”.
We promote regulatory harmonization and improve public health among Asian countries/regions, as well as build trust in Japanese regulatory system.
Yasuhiro Fujiwara, MD, PhD
Pharmaceuticals and Medical Devices Agency