Implementation of Emergency Approval Process and refine the system to cope with new emerging infectious diseases
Committee:IVD (In Vitro Diagnostics)
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.
- 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.