我国“药品上市许可持有人制度”运行现状反思及完善建议

Reflections on the Current Situation of "Drug Listing Permit Holder System" in China and Its Improving Suggestions

":药品上市许可持有人制度"开展了试行以来,显示出了MAH资格条件不完善、保险机制不健全、异地监管困难等诸多问题;为提高《药品管理法》的法律效用,应当完善MAH资格准入条件并建立健全相应的组织机构,完善保险相关制度并将政府救助基金与商业保险相结合,加强异地监管并由委托人所在地药品监督管理部门统一管理。

After the pilot work of "drug listing permit holder system" in China, it is found that the system still has many problems: imperfect MAH qualification;unsound insurance mechanism;supervision difficulty in different places. Therefore, the legal effectiveness of Drug Administration Act should be improved from the following aspects:improving MAH qualification access conditions and setting up corresponding organizations;improving insurance mechanism and combining government relief funds with commercial insurance;and strengthening the supervision in different places and put it under the unified management of the drug regulatory department in the place where the trustor is located.