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四、新药投产前法定的申报资料 1.西药新药投产前法定的申报资料。 (1)临床药代动力学的试验及文献资料。 (2)生物利用度或溶出度的试验资料及文献。 (3)原料及其制剂或复方制剂的稳定性试验资料、结论,抗生素、生化药品及易变质药品的有效期及其依据以及有关文献资料。 (4)生产用药品质量标准草案及起草说明(制剂要包括主药定性试验结果及定量回收试验结果)并提供标准品或对照品。 (5)连续生产的样品3～5批及其检验报告书(样品每批数量至少应为全检需要量的3倍)
Fourth, the new drug before the statutory declaration of information 1. Western drug production before the statutory declaration of information. (1) clinical pharmacokinetic test and literature. (2) bioavailability or dissolution test data and literature. (3) Test materials and conclusions about the stability of raw materials and their preparations or compound preparations, the expiration date of antibiotics, biochemical drugs and perishable drugs, their basis and relevant documents and materials. (4) The draft quality standards for pharmaceuticals used for production and the drafting instructions (the preparations should include the qualitative test results of the main drug and the quantitative recovery test results) and provide the standard or reference substance. (5) 3 to 5 batches of samples continuously produced and their inspection report (each batch of samples should be at least 3 times of the total inspection amount)