Establish a system to prepare for emerging infectious disease outbreaks

Committee:
IVD (In Vitro Diagnostics)
status:
Progress
Published:
The May 2022 revision of the Pharmaceutical and Medical Device Act established an emergency approval system. In September 2023, the "Cabinet Agency for Infectious Disease Crisis Management" was established in the Cabinet Secretariat to prepare for the next infectious disease crisis. In addition, Infectious Disease Control Department was newly established within MHLW. When the National Institute of Health Crisis Management is established in April 2025, we will advance our collaboration with it.

Recommendations

  • IVD industry and other clinical laboratory testing-related organizations should be involved in discussions on the development of a process and system for outbreaks of emerging infectious diseases.
  • IVD related organizations should request the discussion on promoting the development of diagnostic tests related to emerging infectious diseases and on establishing a stable supply system are.