The evolving regulatory system of advanced therapy medicinal products in China: a documentary analysis using the World Health Organization Global Benchmarking Tool standards

Shi, Junnan; Chen, Xianwen; Hu, Hao; Ung, Carolina Oi Lam

doi:10.1016/j.jcyt.2024.04.070

Cytotherapy

2024

DOI: 10.1016/j.jcyt.2024.04.070

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The evolving regulatory system of advanced therapy medicinal products in China: a documentary analysis using the World Health Organization Global Benchmarking Tool standards

Junnan Shi,

Xianwen Chen,

Hao Hu

et al.

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2024

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Regulatory Aspects of Regenerative Medicine in the United States and Abroad

Jaalouk,

Prasai,

Goldberg

et al. 2024

Dermatological Reviews

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BackgroundWith the rising demand for natural‐looking aesthetic improvements, regenerative aesthetic medicine (RAM) has become essential for addressing aging, damage, and imperfections. The regulatory landscape overseeing RAM is dynamic, evolving with new technologies to ensure safety and efficacy.ObjectiveThis study reviews and compares regulatory frameworks for RAM across North America, Europe, Asia, Australia, and Latin America.MethodsRegulations in the United States, European Union (EU), Australia, Singapore, South Korea, Brazil, Argentina, and Mexico were reviewed, focusing on risk‐based approaches, the extent of manipulation, and intended use of biological components.ResultsFrameworks in the United States, EU, Australia, Singapore, and South Korea share a risk‐based approach, adjusting regulations based on risks associated with biological components like stem cells and extracellular vesicles. Minimal alteration is categorized as low risk, emphasizing disease transmission prevention and material quality. Regulatory landscapes vary in Latin America. Brazil's comprehensive framework, managed by ANVISA, categorizes products by manipulation levels. Argentina's ANMAT has made progress, while Mexico lacks a unified framework, leading to unregulated operations and patient risks.ConclusionThe diverse regulatory frameworks underscore the need for continuous collaboration between regulatory bodies, healthcare providers, and stakeholders to promote innovation and ensure safety in regenerative medicine.

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Regulatory Aspects of Regenerative Medicine in the United States and Abroad

Jaalouk,

Prasai,

Goldberg

et al. 2024

Dermatological Reviews

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show abstract

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The evolving regulatory system of advanced therapy medicinal products in China: a documentary analysis using the World Health Organization Global Benchmarking Tool standards

Cited by 1 publication

References 27 publications

Regulatory Aspects of Regenerative Medicine in the United States and Abroad

Regulatory Aspects of Regenerative Medicine in the United States and Abroad

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