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    Home > Active Ingredient News > Drugs Articles > New rapid approval scheme for potential drugs in Europe

    New rapid approval scheme for potential drugs in Europe

    • Last Update: 2016-03-09
    • Source: Internet
    • Author: User
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    Source: on March 9, 2016, the European regulatory authorities launched a new plan to accelerate the approval of promising new drugs to address unmet medical needs, which will provide a lot of support in clinical trials and pharmaceutical development The European Medicines Agency's new plan, called prime, says that priority drugs, which are the latest developments in Cross Atlantic Cooperation to assess real innovative drugs, will be approved more quickly than regulators have in the past In the United States, the food and drug administration has successfully introduced the "breakthrough" title, thus accelerating the approval of innovative drugs for serious diseases such as cancer European agencies say about 100 new drug applications are expected to enter the new PRIME program each year, which aims to promote and better plan medical development and help businesses prepare the data needed for approval more quickly Experimental drugs approved to join the program will be supported by an EMA expert who will be appointed early in the process to provide ongoing support for the overall drug development plan and provide guidance on regulatory strategies The move could help speed up the development and approval of drugs for several indications, such as rare cancers and Alzheimer's disease The plan may also help speed up the development of new antibiotics to meet the rising demand due to antibiotic resistance EMA, which is responsible for drug approval in all EU countries, is currently headquartered in Canary Wharf Financial District, London But if the British people vote in June to leave the EU, the EMA could move out of the UK capital in the future.
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