有这转的功夫， 去看看美国成药和疫苗投发市场的cycle/Approval Process

Vaccine Product Approval Process

The U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER) is responsible for regulating vaccines in the United States.

The sponsor of a new vaccine product follows a multi-step approval process, which typically includes

• An Investigational New Drug application
• Pre-licensure vaccine clinical trials
• A Biologics License Application (BLA)
• Inspection of the manufacturing facility
• Presentation of findings to FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC)
• Usability testing of product labeling

After approving a vaccine, FDA continues to oversee its production to ensure continuing safety. Monitoring of the vaccine and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the vaccine product