Regulatory Aspects of Regenerative Medicine in the United States and Abroad

Abstract

Background

With 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.

Objective

This study reviews and compares regulatory frameworks for RAM across North America, Europe, Asia, Australia, and Latin America.

Methods

Regulations 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.

Results

Frameworks 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.

Conclusion

The 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.