方法:按《新药审批办法》有关外用药局部刺激性研究的规定进行。
Methods: the methods in the "Approval Provision of New Drug" were used.
根据《新药审批办法》的要求进行药效、急性毒性和长期毒性的实验观察。
According to the requirement of Regulations for New Drug Approval, its pharmacodynamics and acute and long-term toxicity tests were observed.
本文着重分析了我国《新药审批办法》存在问题,并提出加快修订的必要性和修改建议。
This article emphatically analyzes the problems existing in the provisions for New Drug Approval in our country, and put forward necessity and some suggestion on revision.
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