Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, HFM 405, Rockville, MD 20850, USA.
Pediatrics. 2011 May;127 Suppl 1:S23-30. doi: 10.1542/peds.2010-1722E. Epub 2011 Apr 18.
The vaccine-approval process in the United States is regulated by the Center for Biologics Evaluation and Research of the US Food and Drug Administration. Throughout the life cycle of development, from preclinical studies to after licensure, vaccines are subject to rigorous testing and oversight. Manufacturers must adhere to good manufacturing practices and control procedures to ensure the quality of vaccines. As mandated by Title 21 of the Code of Regulations, licensed vaccines must meet stringent criteria for safety, efficacy, and potency.
美国的疫苗审批程序由美国食品和药物管理局的生物制品评估与研究中心监管。在从临床前研究到获得许可后的整个开发生命周期中，疫苗都要经过严格的测试和监管。制造商必须遵守良好生产规范和控制程序，以确保疫苗的质量。根据法规第 21 卷的规定，许可疫苗必须符合严格的安全性、有效性和效力标准。
