本文通过对我国药品监督保证体系现行体制的探讨和剖析,提出了我国现行的药品监督保证体系必须改革,并提出实行国家药政监督机构独立另设的设想和建议。对新的国家药政监督机构的职责、任务等进行了设计,对新的药品监督体制的作用及效益进行了评价。 Through the discussion and analysis of the current system of drug supervision and assurance system in our country, this paper proposes that the current system of drug supervision and assurance in our country must be reformed, and proposes the idea and suggestion of implementing the independent establishment of the national drug regulatory agency. The responsibilities and tasks of the new national drug regulatory agencies were designed and the roles and benefits of the new drug regulatory system were evaluated.