The enlightenment of us 505(b)(2) application to modified new drug policy / 中国药学杂志

ABSTRACT

OBJECTIVE: To give advices on the reform of China′s modified new drug policy and implement the design of chemical drug registration classification. METHODS: This paper provides an overview of the 505(b)(2) regulatory pathway with a focus on how modified new drug applications can be submitted. This paper also analyzes the key characteristics among the innovative drug, modified new drug and generic drug registration. This paper compares these key points with China′s new drug registration system and proposes the road to reform. RESULTS: The policy promotes the R&D of the modified new drugs and the development of the pharmaceutical industry. Sponsors can use existing public data in lieu of conducting studies and focus on product innovation. Features are quite different among these three applications in the registration system. The property rights of the modified products are clearly defined. CONCLUSION: It′s necessary for China to legislate regulations of modified new drug. The policy is positioned to promote clinical improvement, reduces duplication of research and improves property rights protection.