New safe medicines faster: A proposal for a key action within the European union's 6th framework programme.

Pharmacology & toxicology Pub Date : 2000-01-01
O J Bjerrum
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Abstract

The global competitiveness of the European pharmaceutical industry is under threat. Technology currently available for the development of new medicines is unable to match the pace of drug discovery and design; and the ever-growing demand for safety, efficacy and quality documentation has increased the cost and time involved in getting new medicines on the market. Although the pharmaceutical industry is one of the strongest in Europe in terms of research, innovation, exports and employment, there are severe restrictions on its ability to create wealth and launch safe drugs for the treatment of common and rare afflictions. The present situation should not be allowed to continue. For this reason, the European Federation for Pharmaceutical Sciences (EUFEPS) has proposed a key action under the title "New safe medicines faster" for the forthcoming EU 6th RTD framework programme. The key action has three main objectives: to seek new technologies capable of more effective selection of potential drug candidates for innovative medicines while accommodating safety demands; to use such technologies to speed up the pharmaceutical development process and eliminate bottlenecks created by initial exploratory drug research; and to cultivate a pan-European interdisciplinary network that bridges the gap between industry, academia and regulatory authorities. By involving regulatory authorities early on and fuelling research and innovation with EU money it should be possible to create a new set of recognised European standards whereby new safe medicines can be brought onto the market faster and cheaper.

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更快地开发新的安全药物:欧盟第六个框架规划内的一项关键行动建议。
欧洲制药业的全球竞争力受到威胁。目前用于开发新药的技术无法跟上药物发现和设计的步伐;对安全性、有效性和质量文件的需求不断增长,增加了新药上市的成本和时间。尽管制药行业在研究、创新、出口和就业方面是欧洲最强的行业之一,但其创造财富和推出治疗常见和罕见疾病的安全药物的能力受到严格限制。不应让目前的局势继续下去。出于这个原因,欧洲药物科学联合会(EUFEPS)为即将到来的欧盟第6次RTD框架规划提出了一项题为“更快地开发新的安全药物”的关键行动。关键行动有三个主要目标:寻求能够更有效地为创新药物选择潜在候选药物的新技术,同时满足安全要求;利用这些技术加快药物开发过程,消除最初探索性药物研究造成的瓶颈;建立一个泛欧洲的跨学科网络,弥合工业界、学术界和监管当局之间的差距。通过尽早让监管机构参与进来,用欧盟的资金推动研究和创新,应该有可能创建一套新的公认的欧洲标准,从而使新的安全药物能够更快、更便宜地进入市场。
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