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首页> 外文期刊>Drugs of today: Medicamentos de actualidad >DRUG-DEVICE COMBINATION PRODUCTS: REGULATORY LANDSCAPE AND MARKET GROWTH
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DRUG-DEVICE COMBINATION PRODUCTS: REGULATORY LANDSCAPE AND MARKET GROWTH

机译：药物组合产品：管制性景观和市场增长

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摘要

Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products, leading to safer and more effective treatments thanks to careful and precise drug targeting, local administration and individualized therapy. These technologies can especially benefit patients suffering from serious diseases and conditions such as cancer, heart disease, multiple sclerosis and diabetes, among others. On the other hand, drug-device combination products have also introduced a new dynamic in medical product development, regulatory approval and corporate interaction. Due to the increasing integration of drugs and devices observed in the latest generation of combination products, regulatory agencies have developed specific competences and regulations over the last decade. Manufacturers are required to fully understand the specific requirements in each country in order to ensure timely and accurate market access of new combination products, and the development of combination products involves a very specific pattern of interactions between manufacturers and regulatory agencies. The increased sophistication of the products brought to market over the last couple of decades has accentuated the need to develop drugs and devices collaboratively using resources from both industries, fostering the need of business partnering and technology licensing. This review will provide a global overview of the market trends, as well as (in the last section) an analysis of the drug-device combination products approved by the FDA during the latest 5 years.
机译：组合产品是将药物，设备和/或生物产品组合在一起的治疗和诊断产品，由于精心而精确的靶向药物，局部给药和个体化治疗，可导致更安全，更有效的治疗。这些技术尤其可以使患有严重疾病和状况（例如癌症，心脏病，多发性硬化症和糖尿病等）的患者受益。另一方面，药物设备组合产品也为医疗产品开发，监管批准和企业互动引入了新动力。由于在最新一代组合产品中观察到的药物和设备的日益集成，在过去的十年中，监管机构制定了特定的职能和法规。要求制造商充分了解每个国家/地区的具体要求，以确保及时，准确地获得新的组合产品的市场准入，并且组合产品的开发涉及制造商与监管机构之间非常特殊的互动模式。在过去的几十年中，投放市场的产品日益成熟，这凸显了使用两种行业资源共同开发药物和设备的需求，从而增加了业务合作和技术许可的需求。这次审查将提供有关市场趋势的全球概述，以及（在最后一节中）对最近5年内FDA批准的药品组合产品的分析。

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