Truly disruptive medicine innovation and new treatment paradigms tend to start in non-commercial research institutions. However, the lack of mutual understanding between medicine developers and regulators when it comes to medicine development significantly delays or even prevents the access of patients to these innovations. Here, we outline what regulatory-related barriers hamper the translational development of novel products or new treatment paradigms initiated in academia, and propose key steps towards improved regulatory dialogue among academia, funding bodies and regulatory authorities. Moreover, we briefly describe how the STARS (Strengthening Training of Academia in Regulatory Science) project aims to reach out to medicine innovators in academia to bridge the regulatory knowledge gap and enhance this dialogue to facilitate the implementation of academic research findings in clinical practice.

真正具有颠覆性的医学创新和新的治疗范式往往始于非商业研究机构。然而，在药物开发方面，药物开发商和监管机构之间缺乏相互理解，大大延迟甚至阻止了患者获得这些创新。在这里，我们概述了哪些与监管相关的障碍阻碍了学术界发起的新产品或新治疗范式的转化开发，并提出了改善学术界、资助机构和监管机构之间监管对话的关键步骤。而且，