Conditional Approval Opens the Door to Regenerative Medicine Therapies



Dr Steven Bradshaw and Dr David Carr of Market Access Solutions (MKTXS) discuss a new framework for conditional (pre-full license) approval of regenerative therapies in Japan … Legislation that came into force in November 2014 is paving the way for a potential influx of regenerative medicines into the Japanese market. The Pharmaceuticals, Medical Devices and Other Therapeutic Products (PMD) Act outlines a framework for expedited conditional approval for cell-based therapies while a...
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