UK Claims World First With ‘Point Of Care’ Manufacturing Rules
MHRA Says New Rules Will Increase Availability Of Innovative New Products
The MHRA says its proposals for a new, tailormade regulatory regime for personalized medicines manufactured at the point of care are evidence of its “intent to move away from a common perception of regulators as a progress blocker to a progress enabler.”
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In a world where pharmaceuticals could be manufactured with no fixed address, industry and regulatory authorities must work together to interpret site-based compliance requirements, expert says. New concepts like the MHRA-proposed hub-and-spokes model could play key role.
Use of robotic aseptic manufacturing techniques is increasing, but regulatory agencies are giving conflicting feedback, according to an industry executive. The dilemma points to the need for more development of and consistency in regulation for advanced manufacturing.
In Cleveland and Moscow, researchers found freshly-manufactured T-cells showed faster reduction of tumor burden than cryopreserved cells, but uncertainty remains about what the clearance process for the technology will be at the US FDA.