Harmonising Global Regulatory Requirements for Biologicals

Authors

  • R. Deeksha Bhavani, Raghava.D, Nageswara Rao.K, Naga Sravani.P Author

DOI:

https://doi.org/10.48047/

Keywords:

Biological products, regulatory frameworks, vaccines, monoclonal antibodies, recombinant proteins, FDA, EMA, PMDA, CDSCO, ICH, WHO, harmonization, global marketing authorization, biosimilars

Abstract

Biological products, including vaccines, monoclonal antibodies, and recombinant proteins, are regulated differently across the globe due to their complex nature and high risk profile. These divergent regulatory frameworks pose challenges for global marketing authorizations, manufacturing consistency, and patient access. This project aims to explore and compare 

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Published

2025-10-07

Issue

Vol. 16 No. 10 (2025): Volume 16 Issue 10 (2025)

Section

Articles