Marketing Approval For Medicinal Products Essay

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There are accelerated pathways in different countries to make available new therapy for their patients, who have unmet needs. The USA, UK and Japan are offering an accelerated marketing approval for the medicinal products. USA: USFDA is offering a Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review options to expedite the medicinal products approval. Fast Track designation - drugs that treat serious illnesses and fulfill unmet medical needs, manufacturer gets more support and advice from the FDA to accelerate the approval process. Breakthrough Therapy – medicinal product that supports unmet need and shows important benefits over existing drugs gets fast track designation, and gets more intensive guidance from the FDA. Accelerated Approval process -drugs that fulfill an unmet need in a serious condition, and that can establish an effect on a substitute indicator or intermediary clinical endpoint can get early approval before providing full clinical data, but company has to make a commitment to conduct phase IV confirmatory trials (FDA, 2016). Priority Review –Approval process time reduced from 10 months to 6 months. UK: In the UK, the early access medicine scheme introduced in the year 2014 for the purpose of allowing patients who suffer from life threatening or serious worsening medical conditions to access the medicines that did not get yet a marketing authorization. An application of Promising Innovative Medicines (PIM) to the MHRA (Medicines

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