REGULATORY FRAMEWORK: VACCINE DEVELOPMENT IN US, INDIA AND EU
DOI:
https://doi.org/10.22159/ijap.2023v15i2.46723Keywords:
Vaccines, Regulation, USFDA, IND, BLA, FDA, MAA, USA, EU, IndiaAbstract
Vaccine development usually takes around 7 y to come to the market after getting necessary regulatory approvals. But recent pandemics like Covid, Ebola, Swine Flu, have resulted in the collaboration of efforts between the government doing investments in vaccine development, academia, regulatory bodies, and industry. This has shortened the timelines for approval for vaccines. In 2009, HINI, Swine flu vaccines took 93 d for identifying the vaccine candidate for clinical trials. In 2014, for Ebola vaccine, it was deployed while the epidemic was still going on. Ebola vaccine was developed in 5 y. In case of Covid (SARS-CoV-2) clinical trials were approved when 2 mo of the pandemic onset. Within a time of 9 mo about 138 vaccine candidates are being reviewed for approval of EUA. This highly helps in the shortening of vaccine development and necessary approval. In this paper, we focused on the regulatory framework of vaccine development in INDIA, US and EU.
Downloads
References
Sathyanarayana SD, Fernandes SD, Castelino LJ, Vadakkepushpakath AN, Shriram RG. Vaccines in the United States: a systematic review on history of evolution, regulations, licensing, and future challenges. Clin Exp Vaccin Res. 2020 Jul 1;9(2):69-75. doi: 10.7774/cevr.2020.9.2.69, PMID 32864362.
Public Health Service. Act Stat. 1944;702:42.
CFR. Code of federal regulations Title 21. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1andshowFR=1. [Last accessed on 21 Jan 2023].
Public Health Service Act, Chapter 373. Title III. In: Stat. 702, Currently codified at 42 U. S. C., Section 262. Section 352. Washington, DC: US Government Printing Office; Jul 1 1944. p. 58.
The history of vaccines as an educational resource. College of Physicians of Philadelphia. Vaccine Development, Testing and Regulation; 2018. Available from: https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation. [Last accessed on 17 Jan 2018]
Market study reports. United States Vaccines Mark 2015-2025: top 21 vaccines analysis, deal trends, players and forecasts; 2018. Available from: https://www.marketstudyreport.com/reports/united-states-vaccines-market2015-2025-top-21-vaccines-analysis-deal-trends-playersand-forecasts.
Han S. Clinical vaccine development. Clin Exp Vaccine Res. 2015;4(1):46-53. doi: 10.7774/cevr.2015.4.1.46, PMID 25648742.
Centres for Disease Control and Prevention (CDCP). Impact of vaccines universally recommended for children. CDCP; 2016. Available from: https://www.cdc.gov/mmwr/preview/mmwrhtml/0005 6803.htm. [Last accessed on 02 Apr 1999]
Rago L, Santoso B. Drug regulation: history, present and future. Drug Benefits Risks Int Textbook Clin Pharmacol. 2008:65-77.
Vaccine introduction guidelines. Gen Introduction Vaccines. Available from: http://whqlibdoc.who.int/hq/2005/WHO_IVB_05.18.pdf.
US. Department of Health and amp; Human Services, Vaccine Basics; 2017. Available from: https://www.vaccines.gov/basics. [Last accessed on 18 Aug 2020]
US. Food and amp; Drug Administration. Vaccines. 2018. Available from: https://www.fda.gov/vaccines-blood-biologics/vaccines.
Lohray BB. Medical biotechnology in India. Adv Biochem Eng Biotechnol. 2003;85:215-81.
Yennapu M. Vaccine policy in India. PLOS Med. 2005;27:e127.
European Medicines Agency. Research and development. Available from: https://www.ema.europa.eu/en/human-regulatory/research-development. [Last accessed on 19 Aug 2020]
https://www.indiascienceandtechnology.gov.in/covid-19-vaccine/vaccine-introduction.
World Health Organization. Brief description of vaccines. http://who.int/topics/vaccines/en.
US Food and Drug Administration. Vaccine and Related Biological product advisory committee. US FDA. Available from: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccines and Other Biologics/Vaccines and Related Biological Products Advisory Committee. [Last accessed on 12 Mar 2018]
US. Food and amp; Drug Administration, Application to Market a New or Abbreviated New Drug or Biologic for Human Use; 2018. Available from: https://www.fda.gov/media/72649/download. [Last accessed on 26 Aug 2020]
Vaccine Testing and the Approval Process. https://www.cdc.gov/vaccines/basics/test-approve.html.
Comparison of regulatory approval process for vaccines development and manufacturing in India and USA M. Bhargavi Thanuja1, Ramaiah Maddi2.
Immunization standard. “National Regulatory Authorities”. Available from: http://www.who.int/immunization_standards/national_regulatory_authorities/rol e/en. [Last accessed on 21 Jan 2023]
BLA (Biologics License Application) process. USFDA. Available from: http://www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/biologics license applications BLA process/default.htm. [Last accessed on 02 Feb 2018]
OPPI position paper on vaccines, Organization of pharmaceutical producers of India.com.
Sensabaugh SM. A primer on CBER’s regulatory review structure and process. Drug Information J. 1998;32(4):1011-30. doi: 10.1177/009286159803200422.
IAP guidebook on immunization. Vaccine introduction guidelines–adding a vaccine to a national immunization program: decision and implementation; 2005.
Vaccine policy, regulations and safety in India NJ Gogtay, MS Dhingra, A Yadav, H Chandwani, a Seth GS Medical College and KEM Hospital, Mumbai, India b Shantha Biotechnics Limited. Hyderabad, India.
Handbook for IBSC members on the website of the Department of Biotechnology. Available from: http://dbtbiosafety.nic.in/Files/Handbook.htm. [Last accessed on 26 Aug 2008]
Drugs and Cosmetics Act of India. Available from: http://www.cdsco.nic.in/html/copy%20of%201.%20DandCAct121.pdf. [Last accessed on 26 Aug 2008]
Central Drugs Standard Control Organization (India). Available from: http://www.cdsco.nic.in/. [Last accessed on 20 Sep 2008]
Review Committee on Genetic Manipulations on the website of the Department of Biotechnology. Available from: http://dbtbiosafety.nic.in/committee/rcgm.htm. [Last accessed on 26 Aug 2008]
Shailaja Pashikanti, Sowmya ANVL, Jyothi Sri Durga V. Regulatory requirements for Vaccine registration in United. State; 2022.
Epidemiology and prevention of vaccine-preventable diseases. Centers for Disease Control and Prevention; 2015. Available from: https://www.cdc.gov/vaccines/basics/testapprove.html. [Last accessed on 25 Feb 2018]
Vaccine product approval process. US FDA. Available from: http://www.fda.gov/biologicsbloodVaccines/DevelopmentApprovalProcess/BiologicsLicenseApplicationsBLAProcess/ucm133096.htm. [Last accessed on 02 Feb 2018]
Pashikanti S, Sowmya AN, Durga JS. Regulatory requirements for vaccine registration in the United States. Int J Drug Regul Aff. 2018;6:85-91. doi: 10.22270/ijdra.v6i2.253.
US Food and Drug Administration. Vaccine and related biological product advisory committee. US FDA. Available from: http://www.fda.gov/Advisory Committees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee. [Last accessed on 12 Mar 2018]
US. Food and amp; Drug Administration, Vaccine Adverse Events; 2018. Available from: https://www.fda.gov/vaccines-blood-biologics/report-problem center-biologics-evaluation-research/vaccine-adverse-events. [Last accessed on 29 Aug 2020]
Shah A, Maheshwari MD. A comprehensive study on comparison of registration process of vaccine in India and USA. J Pharm Sci Bioscientific Res. 2014;4(2):163-71.
EMA. Authorisation procedures. European Medicines Agency; 2020. Available from: https://www.europa.eu/en/authorisation-procedures. [Last accessed on 07 Sep 2020]
Approval of vaccines in the European Union. European Vaccination Information Portal; 2020. Available from: https://vaccination-info.eu/en/vaccine-facts/approval-vaccines European-union. [Last accessed on 08 Sep 2020]
Klug B, Celis P, Ruepp R, Robertson JS. Vaccines: EU regulatory requirements. Mol Vaccines. 2013 Sep 16:845-50.
Notice to Applicants Vol. 2. A–procedures for marketing authorisation. Chapter 4: centralised procedure. Available from: http://ec.europa.eu/health/files/eudralex/vol-2/a/chap4rev200604_en.pdf.
Notice to Applicants Volume 2A–procedures for marketing authorisation. Chapter 2: mutual recognition. Available from: http://ec.europa.eu/health/fi les/eudralex/vol-2/a/vol2a_chap2_2007-02_en.pdf.
Regulation (EC) no 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC); 2007. Available from: http://ec.europa.eu/health/files/eudralex/vol1/reg_2007_1394/reg_2007_1394_en.pdf.
Klug B, Celis P, Carr M, Reinhardt J. Regulatory structures for gene therapy medicinal products in the European Union. Methods Enzymol. 2012;507:337-54. doi: 10.1016/B978-0-12-386509-0.00017-X, PMID 22365782.
Notice to Applicants Volume 2 B–presentation and format of the dossier–Common Technical Document. Available from: http://ec.europa.eu/health/fi les/eudralex/vol-2/b/update_200805/ctd_05-2008_en.pdf
Bhave AC. Indian regulatory update during the COVID-19 pandemic. Perspect Clin Res. 2020;11(3):132-4. doi: 10.4103/picr.PICR_182_20, PMID 33033704.
Biju P, KP, Revadigar V, Dsouza S, Asif Iqbal M, Ahmed G. A review on the impact of the covid-19 pandemic on the health care sector. Int J Pharm Pharm Sci. 2021 Oct 1:1-6. doi: 10.22159/ijpps.2021v13i10.42566.
Tsundue T, SP. Vaccine-induced developmental delay: a case report. Asian J Pharm Clin Res. 2019 Jan 7;12(1):4. doi: 10.22159/ajpcr.2019.v12i1.25900.
Himanshi, Kadam KS, U Uttarwar P. Covid-19 vaccine hesitancy for children in parents: a cross-sectional survey among health-care professionals in India. Asian J Pharm Clin Res. 2022 Aug 7:41-5.
Published
How to Cite
Issue
Section
Copyright (c) 2023 RAMYA PONNAPALLI, MANTENA SRI LAKSHMI DIVYA, KALIDINDI VENKATESWARA RAJU, LAKSHMI PRASANTHI NORI
This work is licensed under a Creative Commons Attribution 4.0 International License.
