◎ 文《法人》杂志全媒体记者惠宁宁新药研发是一个风险高、投资大、周期长的过程,加强对创新药的知识产权保护是医药创新企业的核心诉求。近日,国家药监局发布《药品试验数据保护实施办法(试行)》及配套的工作程序两份征求意见稿(以下简称“新规”),加强对创新药、改良型新药、首家获批仿制药品的数据保护。“中国药品知识产权保护与药品试验数据保护制度是激励医药创新的两大核心机制,二者既相互独立又紧密关联,共同构成...
Source Link◎ 文《法人》杂志全媒体记者惠宁宁新药研发是一个风险高、投资大、周期长的过程,加强对创新药的知识产权保护是医药创新企业的核心诉求。近日,国家药监局发布《药品试验数据保护实施办法(试行)》及配套的工作程序两份征求意见稿(以下简称“新规”),加强对创新药、改良型新药、首家获批仿制药品的数据保护。“中国药品知识产权保护与药品试验数据保护制度是激励医药创新的两大核心机制,二者既相互独立又紧密关联,共同构成...
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