Table 1.

Four NMPA pathways to marketing authorization in China [15,16].

Pathway	Eligible drugs	Review timeline (days)
Priority approval pathway	Drugs with urgent clinical shortage used to prevent and treat major infectious diseases, rare diseases, etc. New types or new dosage forms of pediatric drugs Vaccines for disease prevention and control Drugs included in the breakthrough drug procedure Drugs that meet the conditional approval criteria Drugs that meet other unspecified priority approval situations	70 to 130
Breakthrough therapeutic drug pathway	Drugs used to prevent and treat diseases that are severely life-threatening, or which affect HRQoL, and for which there is no current effective prevention or treatment with significant clinical benefits	130
Conditional approval pathway	Drugs used for the prevention/treatment related to public health incidents (e.g., vaccines)	130
Standard approval pathway	All other drugs that cannot be categorized as outlined above	200

HRQoL – Health-related Quality of Life; NMPA – National Medical Products Administration