Professor of European Union Law, University of Insubria Varese Italy Former Head, Legal Service, European Medicines Agency, Of counsel, Team Leader Healthcare and Life Sciences, BonelliErede Law Firm Milan Italy.
Eur J Health Law. 2020 May 28;27(3):259-273. doi: 10.1163/15718093-BJA10016.
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.
有几个关键因素影响了自欧盟法规 1394/2007 生效以来的前十年中先进治疗药物产品（ATMP）的（非）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 的研究和开发而需要面对的突出挑战，以及从可能的立法改革角度需要考虑的问题。
