This 12-page guide takes the complex global environment for cellular therapeutics and synthesizes it into a clear and concise market brief.
Over the past few years, the regulatory landscape for cell therapy development has grown increasingly complex. There are now accelerated pathways for advanced therapy medicinal products (ATMPs) in several countries worldwide, including the U.S., Japan, and South Korea.
Legislation took effect in Japan in late 2014, in South Korea in 2016, and in the United States in 2017. Additionally, the EU has a program for product acceleration – the Adaptive Pathways.
While the possibility for accelerated commercialization has resulted from these changes, substantial complexity has also been introduced, making it a more elaborate process to move cell therapy products from “bench to bedside.”
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