Regulatory requirements for Vaccine registration in United States

  • Shailaja Pashikanti Dr
  • Sowmya A.N.V.L
  • Jyothi Sri Durga V

Abstract

Vaccination is one among the foremost cost-efficient health interventions out available, saving a lot of individuals from illness, incapacity, and death annually. No alternative countermeasures are effective in reducing or eliminating the prevalence of infectious diseases reminiscent of measles, mumps, rubella, smallpox, and diphtheria. Vaccines are products of biological origin that exhibit some inherent variability. They are characterized by advanced manufacturing processes and are administered to a huge number of healthy youngsters, adolescents, and adults. Their quality cannot be assessed by testing the ultimate product alone. The vaccine industry is highly regulated. Vaccines development maybe an advanced and long method. Before a new vaccine is approved for release into the market, a rigorous restrictive procedure to assess quality, effectiveness, and safety should be undertaken. The Office of Vaccines Research and Review (OVRR) at the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA) are responsible for the regulation of Vaccines. Current authority for the regulation of vaccines is in Section 351(a) of the Public Health Service Act (PHS).  Throughout the lifecycle of development, from preclinical studies to licensure, vaccines are subjected to rigorous testing and oversight. Manufacturers should adhere to good manufacturing practices and management procedures to make sure the quality of vaccines.

Keywords: Vaccines, USFDA, CBER, OVRR, BLA, VAERS.

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How to Cite
Pashikanti, S., S. A.N.V.L, and J. Durga V. “Regulatory Requirements for Vaccine Registration in United States”. International Journal of Drug Regulatory Affairs, Vol. 6, no. 2, June 2018, pp. 85-91, doi:https://doi.org/10.22270/ijdra.v6i2.253.