Table 4.

Emergency regulatory pathways for influenza vaccines’ authorization.

Regulatory Authority	FDA	EMA	NMPA
Names	Emergency Use Authorization	Conditional Marketing Authorization	Emergency Authorization	Special Approval
Statutory articles and guidance	FD&CA 564	Reg. (EC) No. 726/2004 Article 14 (AA) Reg. (EC) No. 507/2006	Vaccine Administration Law Article 20	Procedures for Drugs Special Approval
Regulatory pathways	Emergency authorization (not formal approval)	Approval procedure	Emergency authorization (not formal approval)	Approval procedure
Applicable condition	♦Serious or life-threatening disease or condition ♦Evidence of effectiveness ♦Risk-benefit Analysis ♦No alternatives	♦Fulfil an unmet medical need ♦Positive benefit-risk balance	♦Serious public health emergency ♦Other serious threat to public health	♦State/region emergency ♦Emergency response to public health emergencies ♦Proposal for special approval ♦Others
Review time limit	Hours to days	70 days (emergency procedures) 15–25 days (strain change procedures of mock-up vaccines)	-	Within 15 days
Expiration time	Once public health emergency is over, the EUA is no longer valid, and vaccine still needs formal approval	Valid for 1 year, renewed annually for comprehensive data to convert to formal approval	-	-