Introduction to the spotlight to cell therapy regulation

​Cell therapy regulation is the topic of a 2-month focus on RegMedNet, featuring a variety of content types and covering various key topics and issues in the field,​ including the challenges, trends, developments and debates in the regulation of cell therapies aimed at regenerative medicine applications​.

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Jun 30, 2017
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Cell therapy is a fast-developing field with the potential to have a transformative effect on healthcare. However, cells carry significant potential risks and therefore need careful and regulated investigation and application, to ensure practice is effective, safe and ethical.

Regulatory agencies such as the US FDA, EMA and PMDA aim to facilitate development of safe and effective products, but must keep their policies up to date with the advancement of technology, and balance patient safety versus getting treatments to those in need faster.

Furthermore, there is a lack of harmonization of global regulatory regimens: the Japanese government recently set more flexible and relaxed regulations to advance stem cell-based therapies to market by allowing conditional marketing authorization, but regulation in other countries remains stricter.

This spotlight on cell therapy regulation will aim to provide insight into challenges, trends, developments and debates in the regulation of cell therapies aimed at regenerative medicine applications. We will explore topics such as how policies differ globally, the challenge of steering through the regulatory landscape for both academic researchers and manufacturers, and the number of unproven cell therapies being advertised on the market.

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Features

Panel discussion

  • Join experts from Assymetrex, Cryoport, the Cell and Gene Therapy Catapult and the Centre for the Commercialization - register now!

Editorials

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Journal articles

Regenerative Medicine

News

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