As the Chief Executive of PMDA, I will promote “4Fs (First)” listed below:
Patient First
We make well communication with healthcare professional and work giving the highest priority to patient satisfaction.
Access First
We accelerate the access to innovative medical products of public demand, while ensuring appropriate risk-benefit balance.
Safety First
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”.
Asia First
We promote regulatory harmonization and improve public health among Asian countries/regions, as well as build trust in Japanese regulatory system.
June 2019
Yasuhiro Fujiwara, MD, PhD
Chief Executive
Pharmaceuticals and Medical Devices Agency