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 subjected to rigorous testing and oversight. Manufacturers must adhere to good manufacturing practice (GMP) 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. In section 351(a) of the public health service act (PHS), the current authorities for the regulation of vaccines are given. The present review forces on regulatory issues of vaccines.
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