Implementation of Emergency Approval Process and refine the system to cope with new emerging infectious diseases

Committee:
IVD (In Vitro Diagnostics)
status:
Good progressProgress
Published:
Emergency Approval Process was defined at revision of  Pharmaceutical Law in May 2022. Discussion was initiated on how to prepare for the emerging infectious diseases based on COVID-19 experience.

Recommendations

  • Concrete process and regulation criteria should be defined to put Emergency Approval Process in place with no delay.
  • In the discussion on handling of emerging infectious diseases, stake holders in lab diagnosis, IVD industry should be involved.