Innovation Task Force, Pharmacogenomics and Nanomedicines Drafting Group, European Medicines Agency (EMA), London, UK.
Clin Pharmacol Ther. 2013 May;93(5):425-32. doi: 10.1038/clpt.2013.14. Epub 2013 Jan 24.
This article analyzes the role of regulatory authorities in facilitating innovation in the pharmaceutical sector. We describe how regulators are expanding their role to be not only gatekeepers but also enablers of development. They have already responded to the challenging and changing environment by moving toward a proactive attitude beyond evaluation of products, thereby more actively contributing to their development. Regulators have to continuously evolve their knowledge and standards alongside evolution in science. Creation of supportive regulatory frameworks and multistakeholder interaction will help address unmet regulatory needs.
本文分析了监管机构在促进制药行业创新方面的作用。我们描述了监管机构如何扩大其角色，不仅成为守门员，而且成为发展的推动者。他们已经通过超越产品评估采取积极主动的态度来应对具有挑战性和不断变化的环境，从而更积极地为产品开发做出贡献。监管机构必须随着科学的发展不断更新他们的知识和标准。创建支持性的监管框架和多方利益相关者的互动将有助于解决监管需求未得到满足的问题。
