Table 1.

Accelerated pathways for licensing of influenza vaccines.

Regulatory Authority	FDA	EMA	NMPA
Procedure	Accelerated approval	Accelerated assessment	Priority review
Statutory article and guidance	21 CFR 601.41	Reg. (EC) No. 726/2004 Article 14	Provisions for Drug Registration (2020-issued) Chapter 4
Application period	Clinical phase 2/3	Marketing authorization applications	Biologics license applications
Applicable condition	New drugs offering significant benefit for serious medical conditions with unmet needs	Clinically urgent medicines for public health needs	Vaccines urgently needed for disease prevention and control and innovative vaccines
Accelerating mechanisms/review timelines	Licensed based on preliminary evidence, confirmatory evidence gathered using post-market studies	150 days	130 days