Licensing – relevant principles

Licensing (or licensure) of a vaccine means that a national regulatory authority has formally reviewed all the data on a vaccine based on predefined criteria and characteristics and granted permission for it to be marketed and used in that country or region. What “licensing” involves Regulatory decision: A manufacturer submits a formal application. Data reviewed: Regulators assess studies and quality controls. Outcome: If standards are met, the vaccine is approved. How it differs from authorization Full licensure vs emergency/conditional use: Full licensure is based on a complete data package and is indefinite as long as requirements are met.  Emergency Use Authorizations (EUAs) or Conditional/Accelerated Approvals allow temporary or conditional use based on more limited data in emergencies or high unmet need situations, with obligations for further studies. After licensure Post-licensure monitoring: Even once licensed, every lot of a product is subject to quality control, and regulators continue to monitor on a population basis the safety, effectiveness, and any manufacturing changes. After licensure,...