第五章 药品管理第二十九条 研制新药,必须按照国务院药品监督管理部门的规定如实报送研制方法、质量指标、药理及毒理试验结果等有关资料和样品,经国务院药品监督管理部门批准后,方可进行临床试验。药物临床试验机构资格的认定办法,由国务院药品监督管理部门、国务院卫生行政部门共同制定。完成临床试验并通过审批的新药,由国务院药品监督管理部门批准,发给新药证书。第三十条 药物的非临床安全性评价研究机构和临床试验机构必须分别执行药物非临床研究质量管理规范、药物临床试验质量管理规范。 Chapter V Drug Administration Article 29 For the development of new drugs, the relevant materials and samples such as research methods, quality indicators, pharmacological and toxicological test results, etc., must be submitted in good faith according to the provisions of the drug regulatory department under the State Council. After being approved by the drug regulatory department of the State Council After the clinical trial. The methods for determining the qualification of drug clinical trial institutions shall be jointly formulated by the drug regulatory department under the State Council and the health administrative department under the State Council. The new drug that has completed the clinical trial and passed the examination and approval shall be approved by the drug regulatory department under the State Council and issued a new drug certificate. Article 30 The non-clinical safety evaluation research institutes and clinical trial institutions must separately implement the norms of non-clinical research quality management and the quality management standards of clinical trials of drugs.