There are several critical factors that have influenced the (un)success rate of advanced therapy medicinal products (ATMPs) over the first ten years since the EU Regulation 1394/2007 entered into force. This article provides an overview of the current regulatory scenario and outlines the outstanding challenges to be faced in order to further promote research and development of ATMPs and the issues to be considered in the perspective of a possible legislative reform.

中文翻译：

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探索促进 ATMP 开发和接触欧洲患者的解决方案

自欧盟法规 1394/2007 生效以来的前十年里，有几个关键因素影响了先进治疗药物 ( ATMP )的（未）成功率。本文概述了当前的监管情况，并概述了为进一步促进ATMP的研究和开发而面临的突出挑战以及从可能的立法改革的角度考虑的问题。