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

|View full text |Cite

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.

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...

Citation Types

Supporting

Mentioning

Contrasting

Year Published

2024

Publication Types

Select...

Article2

Relationship

Self Cite0

Independent2

Authors

Journals

Cited by 2 publications

References 27 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

Regulatory Aspects of Regenerative Medicine in the United States and Abroad

Jaalouk,

Prasai,

Goldberg

et al. 2024

Dermatological Reviews

View full text Add to dashboard Cite

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.

show abstract

Regulatory Aspects of Regenerative Medicine in the United States and Abroad

Jaalouk,

Prasai,

Goldberg

et al. 2024

Dermatological Reviews

View full text Add to dashboard Cite

show abstract

Bioengineering breakthroughs: The impact of stem cell models on advanced therapy medicinal product development

Granjeiro,

Borchio,

Ribeiro

et al. 2024

World J Stem Cells

View full text Add to dashboard Cite

The burgeoning field of bioengineering has witnessed significant strides due to the advent of stem cell models, particularly in their application in advanced therapy medicinal products (ATMPs). In this review, we examine the multifaceted impact of these developments, emphasizing the potential of stem cell models to enhance the sophistication of ATMPs and to offer alternatives to animal testing. Stem cell-derived tissues are particularly promising because they can reshape the preclinical landscape by providing more physiologically relevant and ethically sound platforms for drug screening and disease modelling. We also discuss the critical challenges of reproducibility and accuracy in measurements to ensure the integrity and utility of stem cell models in research and application. Moreover, this review highlights the imperative of stem cell models to align with regulatory standards, ensuring using stem cells in ATMPs translates into safe and effective clinical therapies. With regulatory approval serving as a gateway to clinical adoption, the collaborative efforts between scientists and regulators are vital for the progression of stem cell applications from bench to bedside. We advocate for a balanced approach that nurtures innovation within the framework of rigorous validation and regulatory compliance, ensuring that stem cell-base solutions are maximized to promote public trust and patient health in ATMPs.

show abstract

scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.

Contact Info

customersupport@researchsolutions.com

10624 S. Eastern Ave., Ste. A-614

Henderson, NV 89052, USA

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Blog Terms and Conditions API Terms Privacy Policy Contact Cookie Preferences Do Not Sell or Share My Personal Information

Made with 💙 for researchers

Part of the Research Solutions Family.

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 2 publications

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

Bioengineering breakthroughs: The impact of stem cell models on advanced therapy medicinal product development

Contact Info

Product

Resources

About