• 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
  • LAKSHMI PRASANTHI NORI Department of Pharmaceutical Regulatory Affairs, Shri Vishnu College of Pharmacy, Bhimavaram, Andhra Pradesh, India



Vaccines, Regulation, USFDA, IND, BLA, FDA, MAA, USA, EU, India


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.


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How to Cite

PONNAPALLI, R., DIVYA, M. S. L., RAJU, K. V., & NORI, L. P. (2023). REGULATORY FRAMEWORK: VACCINE DEVELOPMENT IN US, INDIA AND EU. International Journal of Applied Pharmaceutics, 15(2), 63–71.



Review Article(s)