Navigating Biologics Regulation: A Deep Dive into Australian Compliance
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- 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 V
Department 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.
Received: 27-01-2024; Revised: 26-02-2024; Accepted: 12-04-2024.
Volume 13, Issue 1 · pp. 9-21 · 2024 · DOI: 10.5530/ajbls.2024.13.2
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. (2024). 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
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© 2024 Author(s)
This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. CC BY 4.0