《生命科学》 2016, 28(8): 949-957
摘 要：摘 要：干细胞是现代再生医学的重要组成部分。就临床转化而言，作为“药品”或“医疗技术”的干细胞，其整个研发路径充满各类挑战。在“法规- 监管- 指导原则”监管体系中，这些挑战可分别归纳到“法规”、“监管”或“指导原则”三个层次。我国以往的法规监管体系发展相对滞后，导致整个监管体系的各个层面均存在不同程度的问题，加之整个社会法规意识淡薄，与研发相关的监管问题在我国表现的尤为突出。本文主要从学术探讨方面，以讨论生物医药的“法规- 监管- 指导原则”体系为基础，试图理清我国干细胞研发中的各种问题与该体系不同层面的对应性，目的是帮助在干细胞研发及监管中建立有效的法规监管思维，进而建立相关监管措施或监管体系。
Abstract: Abstract: Stem cells represent a very important part of modern regenerative medicine. From perspectives of clinical translation， the pathway of the development of stem cells in forms of either “medicine” or “clinical technology” is full of various challenges. All these challenges， in terms of the “Law-Regulation-Guidance” regulatory system， can be associated with different layers of the system， which are the layers of Law， Regulation or Guidance. Since the buildup of the “Law-Regulation-Guidance” system for biomedical products has been generally lagged behind in China， various challenges in all three layers of the system remain to be urgently addressed. It is thus understandable that no current regulatory system can be directly fit into the need of stem cell development in China. In addition， the general lack of the sense of observing the law in the entire society makes the situation even more difficult. Through engaging in an academic discussion on the “Law-Regulation-Guidance” system for biomedical products in general，this paper attempts to clarify the regulatory features of the existing problems encountered in clinical development of stem cells according to the three-layer regulatory system with a hope of helping build up the regulation-driven thinking during the product development and the associated regulation， and moreover， establish the regulatory system dedicated to the regulation of stem cell products in China.
