European Journal of Biomedical and Pharmaceutical Sciences

COMPARATIVE REGULATORY PATHWAYS FOR VACCINE APPROVAL: INSIGHTS FROM THE USA, EUROPE, AND INDIA

Mamta Choudhary, Komal Nagar, Bharti Yadav, Shivali Rahi*, Ashutosh Upadhayay

ABSTRACT

Vaccines represent one of the most powerful public health interventions, significantly reducing global morbidity and mortality. Their regulatory approval requires rigorous evaluation to ensure safety, efficacy, and quality before widespread use. This article provides a comparative analysis of vaccine approval pathways in the United States, Europe, and India, focusing on legal frameworks, timelines, and reliance mechanisms. The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Central Drugs Standard Control Organization (CDSCO) each follow structured processes involving preclinical evaluation, phased clinical trials, regulatory review, and post-marketing surveillance. Despite these shared fundamentals, notable differences exist in submission procedures, review timelines, and emergency pathways, including the FDA’s Emergency Use Authorization (EUA), the EMA’s Conditional Marketing Authorization (CMA), and India’s Restricted Emergency Use provisions. The COVID-19 pandemic demonstrated the critical role of such accelerated pathways in enabling timely vaccine access and highlighted increasing regulatory convergence. The findings underscore the importance of transparency, harmonization, and cross-regional collaboration to streamline vaccine development, strengthen preparedness for future health emergencies, and ensure equitable global access.

Keywords: Vaccine approval, FDA, EMA, CDSCO, regulatory framework, expedited pathways, global harmonization.