马韶青 司怡君 霍增辉

摘 要 目的：为完善我国药品上市许可持有人制度下的区域协作监管机制提供参考。方法：分析药品上市许可持有人制度下区域协作监管的对象及其法律責任，探讨区域协作监管存在的问题，并提出完善区域协作监管机制的建议。结果与结论：委托生产是药品监管部门跨区域协作监管的主要对象。药品上市许可持有人在药品的整个生命周期承担主体责任，受托生产企业承担补充责任。目前区域协作监管存在的问题主要包括缺乏有针对性的执法依据、监管力量不足、取证困难以及监管不及时、部门协作监管机制不健全等。建议从完善区域协作监管的执法依据、构建职业检查员制度、健全区域协作监管的联动机制、加强数据库建设等方面，完善我国药品委托生产的区域协作监管机制。

关键词 药品上市许可持有人制度;区域协作;监管机制;完善

ABSTRACT   OBJECTIVE： To provide reference for perfecting regional cooperation supervision mechanism under the marketing authorization holder （MAH） system in China. METHODS： Based on the analysis of legal responsibilities of the MAH and entrusted manufacturing enterprise， the problems were studied and suggestions for improving the regional cooperative supervision mechanism were put forward. RESULTS & CONCLUSIONS： Sub-contract production is the main target of cross-regional collaborative supervision of drug regulatory agencies. The MAH is responsible for the entire life cycle of the drug， and the entrusted manufacturing enterprise assumes supplementary responsibility. At present， the problems of regional cooperation supervision are lacking of targeted legal enforcement basis， insufficient supervision power， difficulty in obtaining evidence， untimely supervision and inadequate department cooperation supervision mechanism. It is necessary to improve the regional cooperative supervision mechanism continuously in perspectives of perfecting legislation， establishing professional inspector system， improving departmental linkage mechanism， and strenghtening the database construction.

KEYWORDS   MAH system; Regional cooperation; Supervision machanism; Perfection

2019年修订的《药品管理法》第三章重点规定了药品上市许可持有人制度，明确了药品上市许可持有人在药品的整个生命周期承担主体责任。2020年，国家市场监督管理局通过了新修订的《药品生产监督管理办法》（以下简称“新《办法》”），进一步细化了药品上市许可持有人的责任和药品监管部门的职责。从全国的实践来看，该项制度前期的试点工作取得了一定的成效，但也给药品监管带来了新的挑战[1]。异地监管则是实施药品上市许可持有人制度的主要障碍之一[2]，其突出的问题体现在执法标准不统一、取证困难、部门协调机制不健全等方面[3-4]。……