遇有特殊情况的，经国家药品监督管理局批准，可以适当延长。
In case of special circumstances, the time period may be appropriately extended upon the approval by the SDA.
第二十三条药物临床前研究应当参照国家药品监督管理局发布的有关技术指导原则进行。
Article 23 Investigational study of new drugs shall be conducted by referring to the relevant technical guiding principles promulgated by the SDA.
1998年国家药品监督管理局成立后，建立了国家药品监督管理局药品认证管理中心。
In 1998, after the establishment of the state drug administration, establish the state drug administration authentication management center of drugs.
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