Navigating Regulatory requirements for Stem Cells Therapy- A review on Regulations of US, European Union, Japan and India
Abstract
Regenerative medicine is an emerging branch of medicine holding tremendous power to cure in contrary to conventional treatment. Stem cells being at forefront of regenerative medicines holds unprecedented capability of self-renewal and cell differentiation, where this capability is the sole of the stem cell therapy. The cell therapy works by replacing the injured and collapsed cells with the regenerative ones in a chronic condition. But as there are always accompanying downsides with every benefit in this case it’s the ethical consideration, risk and cost associated to the usage and treatment. This review article aims to analyze the status of both stem cell therapy and research by outlining the regulatory landscape for developing, manufacturing and conducting of stem cell therapy in the countries namely US, EU, Japan and India in a comparative mode. The unethical and unproven stem cell tourism happening worldwide will also be highlighted in this review. In the realm of life-threatening medical procedures, addressing regulatory loopholes is a matter of utmost importance. The need for well-coordinated, robust, and meticulously enforced regulations cannot be overstated. These comprehensive regulatory frameworks play a pivotal role in ensuring that scientific advancements in this domain are conducted with the highest levels of safety and ethical integrity
Keywords:
Stem cells, Regulations, Regulatory framework, Advanced Therapy Medicinal Products (ATMPs), Regenerative medicine, Stem cell tourism, Medical Tourism, Embryonic Stem Cells (ESC), CBER, FDA
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References
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Khabade AM, Agarwal SS, Mahajan HB, Mandlik SK. Navigating Regulatory requirements for Stem Cells Therapy- A review on Regulations of US, European Union, Japan and India. Int J Drug Reg Affairs [Internet]. 2024Sep.15 [cited 2026Jan.31];12(3):66-1. Available from: https://www.ijdra.com/index.php/journal/article/view/704
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