The Director General of Pharmaceuticals and Medical Devices, who currently also serves as the Technical Executive Head of the Food and Drug Administration (BPOM), Dr. L. Rizka Andalucia, visited the Pharmaceutical and Medical Devices Agency (PMDA) office in Japan on April 22, 2024. The visit was warmly received by PMDA Chief Executive, Fujiwara Yasuhiro, M.D., Ph.D., Associate Executive Director for International Regulatory Affairs, Yasuda Naoyuki, M.D., Ph.D., Office Director of Asia Training Center, Dr. Endo Ayumi, and Coordinator of Division of Asia II Office of International Program, Dr. Ishida Hayato. This opportunity was the first direct meeting between the two top leaders of the two national regulatory authorities (NRA). The agenda of strengthening the capacity of medical device regulators was the focus of discussion in the one-hour meeting.

Following up on the signing of the MoU and the assignment of two Ministry of Health health administrators to PMDA since April 2, 2024 for the next year in the framework of the long-term training program, the Director General of Pharmaceuticals conveyed the importance of this program for Indonesia, which is building medical device resilience through building an ecosystem that supports innovation to explore in the regulatory field from PMDA as one of the stringent regulatory authorities (SRA).

Regarding the Ministry of Health's efforts to promote proton beam therapy in cancer treatment, both trainees are expected to learn the regulatory assessment of this medical device, as well as radionuclide therapy, given that Japan has two major proton beam therapy manufacturers, namely Hitachi and Sumitomo.

Dr. Fujiwara said that proton beam therapy is a health technology with a large investment, so it must also be accompanied by studying health technology assessment (HTA). In addition, the Director General of Pharmaceuticals also said that there should be opportunities for trainees to study pharmaceutical regulatory science, such as Advanced Therapy Medicinal Product (ATMP) in the context of knowledge sharing with BPOM, or also open opportunities for evaluators from BPOM to participate in long-term training programs as an agreement being implemented between the Ministry of Health and PMDA.

During her stay in Japan, Dr. L. Rizka Andalucia also participated in the PMDA-ASEAN Reliance Meeting as one of the speakers, and attended the Indonesia-Japan bilateral meeting to discuss PMDA's cooperation with BPOM in enhancing regulatory capacity in the pharmaceutical sector.