随着《药品管理法》的实施,目前我市医疗机构依法申报制剂的日渐增加,现就有关申报问题阐述如下。 医疗机构制剂系指医疗单位根据临床需要或补充市场药品供应短缺,以国家或地方药品(药材)标准收载的药品或中药材为主要原料,经过一定制备工艺,自制或委托加工的制剂。 医疗机构制剂应经药品监督管理部门批准方可用于临床。 With the implementation of the “Drug Administration Law”, at present, medical institutions in our city declare the increasing dosage of preparations according to law, and the relevant declaration issues are hereby expounded as follows. Medical institution preparation refers to the preparation of medical preparations by the medical units based on clinical needs or the shortage of supplementary medicines in the market and the medicines or Chinese herbal medicines contained in the national or local medicines (medicinal herbs) standard as the main raw materials and after a certain preparation process. The preparation of medical institutions should be approved by the drug regulatory department for clinical use.