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Prospects for Harmonizing Regulatory Science Programs in Europe, Japan, and the United States to Advance Regenerative Medicine

Milne, C-P   Mittra, J   Kojima, N   Sugiyama, D   Awatin, J   Simmons, G

Therapeutic Innovation and Regulatory Science  

DOI: 10.1177/2168479016650716

May 2016   (First published online May 2016)

Regenerative medicine (RM) is a game-changing technology with the potential to repair damaged tissues and organs, but its introduction into the clinic is complicated by the fact that Europe, Japan, and the United States are struggling to make appropriate regulatory decisions about advanced technologies that are highly promising but also uncertain and potentially risky. They have adopted the new approach of regulatory science (RS), applying science-based approaches and standards to support regulatory decision making, to address the challenge.

Is RS the right approach for harmonizing the regulatory mechanisms needed to integrate RM into the mainstream of the development continuum for medical products? If so, what are the prospects for harmonization? We examine the current state of the art for RM and RS in the 3 major drug development regions to answer these questions.

The full PDF version of the accepted paper is available for download here.