The 145th Annual Meeting of the Pharmaceutical Society of Japan (Fukuoka)

Organizer: Takashi Misawa (NIHS), Masayuki Takamatsu (Grad. Sch. Sci., Osaka Univ.)

Radiopharmaceuticals, which contain radionuclides and utilize radiation as their therapeutic agent, have long been used as diagnostic agents in PET and other imaging procedures. Recently, within radiopharmaceuticals, theranostics—which can achieve both therapy and diagnostics simultaneously through the selection of specific nuclides—has been gaining attention. Additionally, unlike conventional beta and gamma radiation, alpha-ray therapy has shown high therapeutic efficacy, leading to increased development of radiopharmaceuticals. However, radiopharmaceuticals are subject to complex regulatory frameworks under various laws including the Radioisotope Law, Pharmaceutical Affairs Law, and Medical Care Act, necessitating regulatory streamlining as new drugs are developed and their use becomes more widespread in Japan. Furthermore, with the exception of certain radionuclides, almost all radionuclides rely on imports, raising concerns about potential supply disruptions due to international circumstances. In this symposium, experts from industry, government, and academia will present their perspectives on regulations and initiatives aimed at ensuring stable domestic supply of radiopharmaceuticals.