Comparative Analysis of Drug Marketing Authorization procedures in GCC Countries

Authors

  • Sai Siva Durga Ganesh Addala, Raghava.D, Nageswara Rao.K, Naga Sravani.P Author

DOI:

https://doi.org/10.48047/

Keywords:

Real World Data (RWD), Biological Products, Regulatory Science, Pharmacovigilance, Post-Marketing Surveillance, FDA, EMA, CDSCO, Label Expansion, Regulatory Decision-Making, Real World Evidence (RWE)

Abstract

The growing complexity of biological products and the need for continuous post-marketing surveillance have heightened the importance of Real World Data (RWD) in regulatory decision-making. RWD, derived from sources like electronic health records

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Published

2025-10-07

Issue

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

Section

Articles