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新药概念拟做修改 3月1日,在全国药品注册会议上讨论了当前的一些热点问题。一、新药的定义:在《药品管理实施办法》(修订)中,新药概念拟改为:新药指未在我国上市销售过的药品。这一定义有利于增加国内企业的国际化意识,促进国内企业参与国际竞争。不利之处是国外药品一旦在国内注册,就要按新药对待,不能盲目仿制。二、新药保护问题:有利于促进我国新药的研制与开发,但是专利保护却更符合国际惯例。郑筱萸局长认为新药保护政策不能笼统地说保留或取消,应区别对待,要学会用WTO规则最大限度地发展自己。
New drug concept to be revised March 1, at the National Drug Registration Conference discussed some of the current hot issues. I. Definition of New Drugs: In the Measures for the Implementation of Drug Administration (Revised), the concept of new drugs is proposed to read as follows: New drugs refer to drugs that are not marketed in our country. This definition is conducive to increasing the awareness of internationalization of domestic enterprises and promoting the participation of domestic enterprises in international competition. The downside is that once a foreign drug is registered in the country, it must be treated as a new drug and can not be blindly copied. Second, the protection of new drugs: is conducive to promoting the development of new drugs in China, but patent protection is more in line with international practice. Secretary Zheng Xiaoyu believes that the new drug protection policy can not be generally said to be retained or canceled. Different treatment should be made and the WTO rules should be used to maximize the development of oneself.