论药品上市许可持有人的法律规制——以新《药品管理法》为视角

On the legal regulation of Marketing Authorization Holder——Perspective of new Pharmaceutical Administrative Law

2019年8月修订的《药品管理法》正式引入了药品上市许可持有人(MAH)制度,这是发达国家的通行做法。MAH制度既有创新导向元素,亦有安全管控色彩,二者具有张力关系。参鉴比较法,结合国情,我国应当在理念上明确MAH制度安全管控的核心和优先地位,作为后续释法、修法、执法的依据应逐步建立MAH执照制度,应简化MAH下的人事结构,淡化“法定代表人”“主要负责人”的法律描述,明确建立以“药品质量负责人”为核心的人事架构,厘清个人责任的性质和范围。

The revised Pharmaceutical Administrative Law in August 2019 formally introduced the system of Marketing Authorization Holder(MAH),which is common practice in developed countries. MAH system has not only innovation-oriented elements, but also elements of risk-control, which is somewhat contradictory. Referring to the comparative law and considering the national condition, we should define the core and priority status of risk-control and serve as the foundation of legal interpretation, legal amendment and legal enforcement. We should gradually establish the MAH licensing system. Besides, we should simplify the personnel structure of MAH, dilute the legal description of legal representative and principal person in charge, erect the personnel structure at the core of Head of Pharmaceutical Quality and clarify the nature and scope of individual responsibility.