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Published on: September 25, 2016
Cell and tissue therapy regulation: worldwide status and harmonization
Srinivasan N Kellathur1, Huei-Xin Lou
1Pharmaceuticals and Biologics Branch, Pre-Marketing Division, Health Products Regulation Group, Health Sciences Authority, Singapore, Singapore. kellathur_srinivasan@hsa.gov.sg
Summary
Advancements in stem cell and tissue engineering necessitate clear regulations for cell and tissue-based products (CTTPs). This review examines global regulatory frameworks for CTTPs in major regions.
Area of Science:
- Stem cell biology
- Tissue engineering
- Regulatory science
Background:
- Rapid scientific and technological progress in stem cell biology and tissue engineering.
- Increasing use of human cells and tissues for therapeutic applications.
- Evolving regulatory landscape for cell and tissue-based products (CTTPs).
Purpose of the Study:
- To review and highlight current regulatory controls for CTTPs.
- To examine the establishment of risk-based regulatory systems.
- To provide an overview of regulatory approaches in key global regions.
Main Methods:
- Literature review of regulatory documents and agency statements.
- Comparative analysis of regulatory frameworks.
- Identification of common features in risk-based systems.
Main Results:
- Drug regulatory agencies are developing risk-based systems for CTTPs.
- Various countries/regions have implemented specific regulatory controls.
- Key regions examined include Australia, Canada, Europe, Japan, Korea, Singapore, and the USA.
Conclusions:
- Harmonization of regulatory approaches for CTTPs is ongoing.
- Effective regulation is crucial for ensuring the safety and efficacy of regenerative medicine products.
- International collaboration is essential for navigating the complex regulatory environment.
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