In April 2019, Yasuhiro Fujiwara was appointed as the new chief executive of Japan’s drug regulator and one of the world’s foremost regulatory bodies, the Pharmaceuticals and Medical Devices Agency (PMDA). Upon appointment, Fujiwara coined the “Four Fs” strategy, urging PMDA employees to have a “patient first,” “access first,” “safety first,” and “Asia first” mentality.


Japan’s PMDA should be the one leading Asia

Yasuhiro Fujiwara, chief executive, PMDA

Dr Fujiwara, 59, was previously deputy director of Japan’s National Cancer Center (NCC) Hospital, where he headed up the laboratory test division and clinical trial and therapy development division and was director-general of the NCC’s Strategic Planning Bureau. He took over the role from Tatsuya Kondo, who left the agency after 11 years at the helm. Fujiwara’s first term in office is set to last until 2024.

With the PMDA having been involved in a series of scandals in recent years involving the misconduct of employees, Fujiwara has prioritised greater levels of consultation with agency staff in order to prevent the recurrence of these scandals.


Patient First

As Pharma Japan has reported, Fujiwara told a press conference in May 2019 that he wants PMDA employees to always put patients at the centre of what they do. In concrete terms, this has meant the establishment of a Patient Centricity Working Group which brings together stakeholders to discuss patient engagement.

The working group aims to put forward ways to better involve patients in PMDA’s drug review and safety activities and will compile a guidance in near future. It will also discuss ways to better communicate information for patients and the Japanese public in general. Fujiwara said, “We want to see more patient participation in our drug review and pharmacovigilance activities. So, we set up the work group to discuss how we can do it.”

He also expressed hopes to create more personnel exchange opportunities between the PMDA and hospitals, where young agency staffers can mingle with healthcare professionals on the frontline to understand actual medical needs and harness them in their review and safety work.


Access First

Fujiwara has also urged that the PMDA consistently make efforts to enable people’s early access to a variety of new technologies, whether it be drugs, medical devices, or regenerative medicine products.

PMDA will step up efforts to facilitate the utilization of disease registries for submissions in order to quickly deliver innovative drugs and medical technologies to patients with rare cancers and other orphan diseases.

As part of this push, the PMDA has introduced a pilot-based consultation service on the use of registries in regulatory submissions for drugs, medical devices, and regenerative medicine-based products and has already received enquiries seeking advice.


Safety First

Explaining the “safety first” strategy, Fujiwara noted that, “New drugs, medical devices, and regenerative medicine products are effective, but they might pose the risks of side effects or other problems. Employees should always keep an eye on safety when doing their jobs.”

The PMDA has reinforced pharmacovigilance activities for medicines designated for the sakigake fast-track pathway and the conditional early approval system and also plans to enhance the MID-NET database.


Asia First

On “Asia first,” Fujiwara highlighted the importance of cross-border regulatory collaboration, leveraging the PMDA’s knowhow to develop regulatory frameworks in Asian countries via various channels including its ‘Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs.’

He added, “What we have to do the most is ‘Asia first’ – enhancing our globalization efforts … Japan’s PMDA should be the one leading Asia.”