Abstract

REGULATORY REQUIREMENTS FOR THE APPROVAL OF VACCINE IN INDIA & COMPARISION WITH OTHER COUNTRIES

*Ashok Kumar P., Dheeraj P., Monika T., Monisha M.V., Naveen K.M. and Prem Suresh Kumakale

ABSTRACT

The divergence of regulatory requirements and processes in countries contributes to hinder vaccines’ registration, and therefore delay access to high-quality, safe and efficacious vaccines for their respective populations. This report focuses on providing insights on the heterogeneity of registration requirements in terms of numbering structure and overall content of dossiers for marketing authorisation applications for vaccines in different areas of the world. The development and approval of vaccines are crucial processes in ensuring public health and safety. This abstract provides an overview of the regulatory requirements that vaccines must meet for approval. The regulatory framework varies by country but generally includes rigorous evaluation stages encompassing preclinical studies, clinical trials, manufacturing standards, and post-market surveillance. This abstract highlights the key aspects of vaccine regulation, emphasizing the importance of safety, efficacy, quality control, and transparency.

Keywords: Cdsco, Usfda, Bla, Maa, Anvisa, Safety, Efficacy.