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Innovative medicines: new regulatory procedures for the third millennium

机译:创新药物:第三个千年的新监管程序

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摘要

Despite tremendous progress in science and increasing investment in research and development, patients' access to innovative medicines remains limited. This is in part due to increasing regulatory requirements for product authorisation and cost-constrained national health systems. At the European Medicines Agency (EMA), we have tried to address these constraints by adapting our organisation and activities to changing business models, new technologies, and the current and emerging health needs in Europe. The main EMA initiatives to provide patients with effective, safe and affordable medicines are reviewed.
机译:尽管科学领域取得了巨大进步,并且在研究和开发方面的投资不断增加,但患者获得创新药物的机会仍然有限。这部分是由于对产品授权和成本受限的国家卫生系统的法规要求不断提高。在欧洲药品管理局(EMA),我们试图通过使我们的组织和活动适应不断变化的商业模式,新技术以及欧洲当前和新兴的健康需求来解决这些限制。审查了为患者提供有效,安全和负担得起的药物的主要EMA措施。

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