REGULATORY FRAMEWORK: VACCINE DEVELOPMENT IN US, INDIA AND EU

Authors

  • RAMYA PONNAPALLI Department of Pharmaceutical Regulatory Affairs, Shri Vishnu College of Pharmacy, Bhimavaram, Andhra Pradesh, India
  • MANTENA SRI LAKSHMI DIVYA Department of Pharmaceutical Regulatory Affairs, Shri Vishnu College of Pharmacy, Bhimavaram, Andhra Pradesh, India
  • KALIDINDI VENKATESWARA RAJU Department of Pharmaceutical Regulatory Affairs, Shri Vishnu College of Pharmacy, Bhimavaram, Andhra Pradesh, India https://orcid.org/0000-0002-6279-4710
  • LAKSHMI PRASANTHI NORI Department of Pharmaceutical Regulatory Affairs, Shri Vishnu College of Pharmacy, Bhimavaram, Andhra Pradesh, India

DOI:

https://doi.org/10.22159/ijap.2023v15i2.46723

Keywords:

Vaccines, Regulation, USFDA, IND, BLA, FDA

Abstract

Vaccine development usually takes around 7 years to come to the market after getting necessary regulatory approvals. But recent pandemics like Covid, Ebola, Swine Flu, have resulted in collaboration of efforts between 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 days for identifying the vaccine candidate for clinical trials. In 2014, for Ebola vaccine it was deployed while epidemic was still going on. Ebola vaccine was developed in 5 years. In case of Covid (SARS-CoV-2) clinical trials were approved when 2 months of pandemic onset. Within a time of 9 months 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 regulatory framework of vaccine development in INDIA, US and EU.

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Published

22-12-2022

How to Cite

PONNAPALLI, R., DIVYA, M. S. L., RAJU, K. V., & NORI, L. P. (2022). REGULATORY FRAMEWORK: VACCINE DEVELOPMENT IN US, INDIA AND EU. International Journal of Applied Pharmaceutics, 15(2). https://doi.org/10.22159/ijap.2023v15i2.46723

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Original Article(s)