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从医药部门了解到,最近,国家科委下发了《药品非临床研究质量管理规定(试行)》实施指南(试行)。 该实施指南强调,药品非临床安全性研究机构(以下简称“机构”)的建设和运行应当符合《管理规定》的要求。机构建成后,先由行业主管部门进行初审,合格者方可向国家科委申请进行认可检查。机构可以是独立法人,也可以附属于某一科研单位或高等学校;可为其附属单
It is learned from the medical department that recently, the State Science and Technology Commission issued the Implementation Guide (Trial Implementation) for “Regulations on Quality Control of Non-clinical Drugs (Trial)”. The implementation guidelines emphasize that the construction and operation of non-clinical drug safety research institutions (hereinafter referred to as “institutions”) should meet the requirements of the “regulatory requirements.” Institutions are completed, the industry department in charge of the first instance, the qualified person may apply to the State Science and Technology Commission for accreditation inspection. Institutions can be independent legal entities, can also be attached to a scientific research institutes or institutions of higher learning; for its subsidiary