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[思考测试题]选择题(单项或多项)1.根据新的《药品注册管理办法》从哪一年开始,企业如变更药品内包材和有效期,由省级食品药品监督管理部门进行审批()A.2011年B.2010年C.2009年D.2008年2.按照《原料药与药物制剂稳定性试验指导原则》,进行加速及长期稳定性试验,至少应有几批产品的研究数据()A.2批B.3批C.6批D.10批3.我国对大输液内包材采用PVC袋的现状处于何种态度()A.支持使用B.不准使用C.逐步淘汰D.不加限制
(Single item or multiple items) 1. According to the new “Regulations on the Registration of Drugs”, from which year the enterprise shall approve such items as the change of the internal packaging materials and the expiration date of the drug products by the provincial food and drug administration department ) A. 2011 B. 2010 C. C. 2009 D. 2008 2. Accelerated and long-term stability testing in accordance with the Guiding Principles for Stability Tests of APIs and Pharmaceutical Preparations should include at least data from several batches of product () A.2 Batch B.3 Batch C.6 Batch D.10 Batch 3. What is the current status of using PVC bag for large transfusion packaging material in China () A. Supporting the use of B. Not allowed to use C. Phase-out D. Without restriction