【摘要】 我国自主研发的抗HIV药物已经进入II期临床试验阶段,目前迫切需要制订对该类药物批准上市的技术要求。现就美国和欧盟对抗HIV药物批准的技术要求进行简单介绍,希望对国内相应药物的研发及批准有所启示。更多还原

【Abstract】 The technical requirements for marketing authorization of antiretroviral drugs are very important,and they are urgently demanded in China now.This article introduced FDA’s and EMEA’s consideration on this aspect,hoping to give some suggestions for investigation and approval of antiretroviral drugs in China.更多还原