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Published on:June 2021
Indian Journal of Pharmaceutical Education and Research, 2021; 55(2s):s353-s363
Review Article | doi:10.5530/ijper.55.2s.106

Comparison and Compilation of the Vaccine Approval Process of the United States of America and the European Union: A Road Map for the Emerging and Developing Countries in COVID-19 Crisis

Authors and affiliation (s):

Sumana Dosemane Radhakrishna1, Ravi Gundadka Shriram2, Shenaz Z. Khaleeli3, Pankaj Dawar3, Megha Chellath Kottayi1, Akhilesh Dubey1

1Department of Pharmaceutical Regulatory Affairs, NGSM Institute of Pharmaceutical Sciences, NITTE (Deemed to be University), Mangaluru-575018, Karnataka, INDIA.

2Formulation and Development, R&D Center, Mylan Laboratories Ltd, Bengaluru, Karnataka, INDIA.

3PharmaLeaf India Pvt. Ltd., Bengaluru, Karnataka, INDIA.


Background: Vaccines are the-omit complex biological preparations that are meant to be used as a treatment or preventive measures against any specific disease condition. Vaccine research and development is a tedious, time and cost consuming process because of stringent quality assessment procedures. Every year approximately 80-85 % of the world’s children receive vaccines; however, regardless of this success rate each year, approximately more than 3 million die from vaccine-preventable diseases in most of the-omit developing countries. Today the entire world is facing a pandemic COVID-19 and the researchers are putting their best effort to bring a vaccine into the market. Developing a vaccine is a tedious process and emerging vaccine into the market requires a whole lot of process. Purpose: The current study aimed to evaluate the vaccine approval processes of two international pharmaceutical regulatory giants and develop a road map for the progress of vaccines in emerging countries to face the challenges posed by COVID-19. Methods: This article expresses the brief updated report of the regulatory approval pathways involved in the vaccines registration process in the United States of America (USA) the European Union (EU). The comparison study serves to understand the regulatory issues involved during the life-cycle of the vaccine approval process in the USA and the EU. Authors advocate the necessity of harmonised guidelines for the vaccine approval process in developing countries. Conclusion: Authors insist on broad global partnerships between the developed and emerging countries for the supply of affordable vaccines across the globe to face the pandemic called COVID-19.

Key words: Vaccines, Marketing authorization application, USA, EU, COVID-19.



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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.


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