基于质量安全视角下的原料药监管模式的构建研究

Research on the Construction of the Supervision Mode of Raw Material Medicine Based on the Perspective of Quality and Safety

为探索创新原料药监管模式,研究将化工企业作为原料药生产主体的可行性。以药品质量保障体系中原料药保障为研究对象,分析我国现行监管模式下化工企业生产原料药所带来的问题。结果发现,相关部门应明确原料药的独立法律地位,制定单独的原料药生产质量管理规范,实行原料药的登记备案管理和生产企业厂商注册制度,创新监管模式,为化工企业生产原料药的科学化、合法化搭建制度平台。

To explore the innovation mode of regulation of raw material medicine, and study the feasibility of chemical companies as a raw material medicine production subject. With the raw material of quality guarantee system of drugs, guarantee as the research object, analysis of problems resulted from the chemical industry for the production of APIs in our present regulation mode. Results and conclusion, the relevant departments should be independent legal status clear APIs, establish a separate raw material drug production quality management standards, the raw material medicine registration record management and production enterprises to implement the registration system, innovate the model of supervision, for the chemical industry raw material medicine science and legalization of build system platform.