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In December 2016 the US Congress enacted the 21st Century Cures Act, which required the FDA to facilitate an efficient development program for, and expedite the review of, new medicines meeting the definition of a regenerative advanced therapy (RAT) (Section 3033). The RAT designation in the legislation is now referred to as the Regenerative Medicine Advanced Therapy (RMAT) designation.
Now that the first two of these therapies have been approved, the supply chain of patient- and donor-derived regenerative medicine products will fall under increasing pressure for standardization and increased regulatory requirements. Much of the early regulatory focus has been on material processing with four guidance documents issued in a regulatory framework established by the FDA on November 16, 2017, its focus is on recovery, isolation, and delivery. Cryoport believes that enhanced traceability within the temperature-controlled and cold chain logistics distribution will also be subjected to additional regulatory requirements due to the fragile aspect of the drug product and the disproportionate risk of improper cold chain management on the viability of the therapies.
Moving time and temperature sensitive biological materials “smoothly” across the globe, from A to B, is and requires more than “just” acquiring compliant packaging material and booking a carrier… While this may seem logic, how are you ensuring visibility to the Chain of Custody, Chain of Condition and more importantly Chain of Compliance™ for your shipment?