Three types of NDAs FDA新药申请的主要类型包括: Full NDA: 505(b)(1): “An application that contains full reports of investigations of safety and effectiveness”. ANDA (An abbreviated NDA): 505(j):“An application for a proposed drug that is identical to a reference listed drug and must demonstrate its bioequivalence”. Hybrid of the full NDA and an ANDA: 505(b)(2): An application for a proposed drug with a limited change to a previously approved product”.
ANDA 申请(505 j)
Biblioteka Baidu
相对于创新药而言,开发时间短,但竞争激励,利 润也相对较少 在中国,有利于政府招标 获FDA批准后,该仿制药就会被加入《已批准药品 名录》(Orange Book)中,该公司就可以生产 和销售这种药物了 欧盟类似,具体要求上有些差异 全球有很多非常成功的仿制药公司:Teva、Apotex、 Sun Pharm. Co. Ltd., Ranbaxy 、Dr. Reddy’s等 ANDA 申请(505 j)
ANDA:Abbreviated New Drug Application(简略新药申 请):即仿制药申请,针对成品药,相关法规505(j) (see 21 CFR 314.101) “简略新药申请”:一般不需要提供临床前和临床数据 (即免毒理和临床)来证明其安全性和有效性 作为替代,申报者必须合理证明其产品与原研药相比是生 物等效的,包括详细的溶出度或释放度比较以及BE研究 (24至36个健康志愿受试者),如果饱腹空腹均可服用, 则要两两交叉(four-period single dose crossover design study,both products fed and fasted ) 仿制药的市场份额