国家药监局已起草《医疗机构制剂审批办法》,于2001年12月1日起执行。该办法重申了修订的《药品管理法》第25条规定:医疗机构配制的制剂,应当是本单位临床需要而市场上没有供应的品种,并须经所在省、自治区,直辖市人民政府药品监督管理部门批准后方可配制。关于法律衔接问题,国 SFDA has drafted the Measures for Examination and Approval of Preparation of Medical Institutions and implemented it on December 1, 2001. The approach reiterated Article 25 of the revised Drug Administration Law stipulating that preparations formulated by medical institutions should be those that are not supplied by the market on the clinical needs of the unit and are subject to the supervision and administration of drug control by the people’s government of the province, autonomous region or municipality directly under the Central Government Department approval before formulating. On the convergence of the law, the country