Copyright © 2026 Authors retain the copyright of this article. This article is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
@article{204830,
author = {A Sai Divya},
title = {Global Regulatory Perspectives on Manufacturing Practices, Quality Assurance and Approval Processes of Herbal Pharmaceutical Products},
journal = {International Journal of Innovative Research in Technology},
year = {2026},
volume = {13},
number = {1},
pages = {3995-3999},
issn = {2349-6002},
url = {https://ijirt.org/article?manuscript=204830},
abstract = {Herbal pharmaceutical products continue to play a vital role in global healthcare systems owing to their historical significance, therapeutic potential, and widespread acceptance among populations. The increasing demand for herbal medicines has expanded international trade; however, significant regulatory differences among countries continue to present challenges for quality assurance, product approval, and market access. This manuscript examines the global regulatory frameworks governing herbal pharmaceutical products, focusing on manufacturing practices, quality assurance systems, and approval pathways in major regulatory regions including India, the United States, the European Union, Japan, Canada, and Russia. The study highlights the regulatory mechanisms employed to ensure safety, efficacy, and quality of herbal medicines while identifying areas requiring harmonization. Comparative analysis reveals that developed regions possess more structured regulatory frameworks, whereas several emerging economies continue to evolve their regulatory systems. Strengthening Good Manufacturing Practices (GMP), standardization procedures, pharmacovigilance mechanisms, and international harmonization initiatives are essential for enhancing global acceptance of herbal products. The findings emphasize the need for a unified regulatory approach that balances traditional knowledge with modern scientific evaluation to facilitate international trade and safeguard public health.},
keywords = {Herbal medicines, Regulatory affairs, Quality assurance, Good Manufacturing Practices, Herbal drug approval, Phytopharmaceuticals, Regulatory harmonization.},
month = {June},
}
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