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1 问:修订后的《新药审批办法》何时开始施行?答:据国家药品监督管理局令第2号,自1999年5月1日起施行。2 问:我国新药的定义是什么?答:据修订后《新药审批办法》第一章第二条:新药系指我国未生产过的药品,已生产的药品改变剂型、改变给药途径、增加新的适应症或制成新的复方
Q: When will the revised Measures for the Approval of New Drugs come into effect? A: According to the No. 2 Order of the State Drug Administration, effective as of May 1, 1999. 2 Q: What is the definition of new drug in China? A: According to the revised Article 2 of Chapter 1 of the Measures for the Approval of New Drugs: New drug refers to drugs that have not been produced in our country, drugs that have been produced to change dosage forms, New indications or made into new compounds