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    Euro Roundup: MHRA contemplates a new regulatory framework for personalized medicines

    MHRA seeks feedback on making personalized medicines at the point of care   The UK Medicines and Healthcare products Regulatory Agency (MHRA) seeking input on whether the production of personalized medicines at the point of care (POC) is sufficiently different from standard manufacturing to require the creation of a new framework.   In contrast to traditional medicine manufacturing, where fewer facilities, working at scale, manufacture products for global distrib...
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    EU Regulatory Roundup: Ireland Extends Falsified Medicine Transition Phase Again to ‘Stabilize’ System

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   Ireland Extends Falsified Medicine Transition Phase Again to ‘Stabilize’ System   Ireland has extended the “use and learn” phase of the implementation of the Falsified Medicines Directive (FMD) for a second time. The implementation phase will now end in a staggered manner starting sometime after the end of September.   When the FMD safety feature requirements ca...