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Asian Journal of Biological and Life sciencesNOW IN
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Navigating Biologics Regulation: A Deep Dive into Australian Compliance

Nayana Saji1, Deeksha Kethareshwara Sujatha1, Balamuralidhara Veeranna1★★ Corresponding author

  1. 1Department of Pharmaceutics, Center of Excellence in Regulatory Sciences, JSS College of Pharmacy, JSS Academy of Higher Education and Research, S.S. Nagar, Mysuru, Karnataka, INDIA.

CORRESPONDENCE

Balamuralidhara Veeranna

Balamuralidhara V

baligowda@jssuni.edu.in

Received: 27-01-2024; Revised: 26-02-2024; Accepted: 12-04-2024.

Volume 13, Issue 1 · pp. 9–21 · PUBLISHED · DOI: 10.5530/ajbls.2024.13.2

View on AJBLS original site ↗

ABSTRACT

Biologics are at the forefront of therapeutic breakthroughs, marking a paradigm change in medical therapies in an ever-evolving field. Complex biological products known as biologics are used to treat a variety of illnesses and disorders and both their development and marketing are governed by strict rules. Australia’s regulatory agency, the Therapeutic Goods Administration (TGA), employs rigorous pre-approval assessments and post-marketing surveillance to guarantee the effectiveness, safety and quality of biologics. The article concludes that Australia’s regulatory guidelines for biologics are intended to safeguard the general public’s health and guarantee that patients receive reliable medical care.

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    Saji, N., Sujatha, D. K., & Veeranna, B. (). Navigating Biologics Regulation: A Deep Dive into Australian Compliance. Asian Journal of Biological and Life sciences, 13(1), 9–21. https://doi.org/10.5530/ajbls.2024.13.2