Regulatory requirements for Vaccine registration in United States
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.
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:
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: https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDAMA/default.htm
11. U.S Food and Drug Administration, “Vaccine and Related Biological product advisory committee” [Internet]. USFDA [cited 2018 Mar 12]. Available from:
http://www.fda.gov/AdvisoryCommittees/ 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: http://www.fda.gov/ 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: http://www.fda.gov/Biologics 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:
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM
Rights of Authors:
The International Journal of Drug Regulatory affairs. recognize the retention of the following:
- Patent and trademark rights and rights to any process or procedure described in the article.
- The right to photocopy or make single electronic copies of the article for their own personal use, including for their own classroom use, or for the personal use of colleagues, provided the copies are not offered for sale and are not distributed in a systematic way outside of their employing institution (e.g. via an e-mail list or public file server). Posting of an article on a secure network (not accessible to the public) within the author’s institution is permitted.
- The right, subsequent to publication, to use the article or any part thereof free of charge in a printed compilation of works of their own, such as collected writings or lecture notes.
Note: All copies, paper, electronic or other use, of the information must include an indication of the IJDRA copyright and a full citation of the journal source.
- If the article was prepared jointly with other author(s), the signing author has informed the co-author(s) of the terms of this copyright transfer and is signing on their behalf as their agent and represents that he or she is authorized to do so, then please confirm by checking the appropriate box following the signature line. The signing author shall bear the responsibility for designating the co-author(s) and must inform the IJDRA of any changes in authorship.
- If copyright is held by the employer, then the employer or an authorized representative of the employer must sign. If the author signs, it is understood that this is with the authorization of the employer and the employer’s acceptance of the terms of the transfer.
The author(s) warrant(s) that the article is the author’s original work and has not been published before. The author(s) warrant(s) that the article contains no libelous or other unlawful statements, and does not infringe on the rights of others. If excerpts from copyrighted works are included, the author(s) has (have) obtained or will obtain written permission from the copyright owners and will credit the source in the article.
Preprints: The author(s) must agree that if a prior version of this work (normally a preprint) has been posted to an electronic public server, they will not update and/or replace the prior version in order to make it identical in content to the final published version.