Regulatory requirements for Vaccine registration in United States

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


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.


Download data is not yet available.


1. Centers for Disease Control and Prevention (CDCP). Impact of vaccines universally recommended for children [Internet].United States: CDCP; 2016 [cited 1999 Apr 2]. Available from:
2. Rägo L, Santoso B. Drug regulation: history, present and future. Drug Benefits and Risks: International Textbook of Clinical Pharmacology.2008;65-77.
3. The history of vaccines as an educational resource. Vaccine Development, Testing and Regulation [Internet]. United states: The college of Physicians of Philadelphia: 2018 [cited 2018 Jan 17]. Available from:
4. Biologics Control Act.[Internet]. United states:1902 Jul 01 [cited 2018 Jan 16]. Available from: Control_Act.htl.
5. Food Drug and Cosmetic [Internet]. Legal information institute: 1906 Jul 30 [cited 2018 Jan 06]. Available from:
6. Regulation of biological products [Internet].uscode [cited 2018 Jan 04]. Available from:
7. Marshall V, Baylor NW. Food and Drug Administration regulation and evaluation of vaccines. Pubmed [Internet]. Pubmed; 2011 Apr 18 [cited 2018 Apr 23] Available from:
8. Shulman SR, Kaitin KI. The prescription drug user fee act of 1992. PharmacoEconomics. 1996 Feb 1; 9(2):121-33. Available from:
9. Food and Drug Administration Modernization Act of 1997. Quantitative and Qualitative Analysis of Mercury Compounds in the List [Internet]. US FDA; 2018 Mar 28 [cited 2018 Apr 21]. Available from:
10. Food and Drug Administration Modernization Act (FDAMA) of 1997 [Internet]. USFDA; 2018 Mar 28 [Cited 2018 Apr 21]. Available from:
11. U.S Food and Drug Administration, “Vaccine and Related Biological product advisory committee” [Internet]. USFDA [cited 2018 Mar 12]. Available from: Committees Meeting Materials/Blood Vaccines and Other Biologics/Vaccines and Related Biological Products Advisory Committee
12. BLA (Biologics License Application) process [Internet]. USFDA [cited 2018 Feb 2]. Available from: biologics blood vaccines/ development approval process/biologics license applications BLA process/default.htm.
13. Vaccine product approval process [Internet]. USFDA [cited 2018 Feb 2] Available from: Blood Vaccines/Development Approval Process/Biologics License Applications BLA Process/ucm133096.htm.
14. Shah A, Maheshwari MD. A Comprehensive Study on Comparison of Registration Process of Vaccine in INDIA and USA. Journal of Pharmaceutical sciences and bioscientific research. 2014; 4(2):163-71.
15. Epidemiology and prevention of vaccine- preventable diseases. Ceters for Disease control & Prevention [Internet]. CDC; 2015 Sept 08 [cited 2018 Feb 25]. Available from:
1002 Views | 1702 Downloads
How to Cite
Pashikanti, S., S. A.N.V.L, and J. S. 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:10.22270/ijdra.v6i2.253.