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

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.

The Feasibility of the Connection between the Drug Patents Examination and the New Drug Registration / 中国药学杂志

OBJECTIVE: To improve the feasibility of the connection between the drug patents examination and the new drug registration and design the connecting pattern between them, which will enhance the appearance on the market for the patent drugs, eventually increase the drug choice for the public. METHODS: To find the connecting space between drug patents examination and the evaluation standards for drug registration by comparing the "novelty", "inventiveness", "practical applicability" standards for a patent with the "safety", "efficacy" and "quality" standards for drug registration. RESULTS AND CONCLUSION: A large connecting space between the practical applicability standard for a patent and the evaluation standards for drug registration is found in this paper. The practical applicability standard for a patent can be adjusted dynamically according to the evaluation standards for drug registration based on the development level of the pharmaceutical industry, interests of patent holders and the public, etc.

Comparison and reference of foreign expedited approach for new drug review / 中国药学杂志

OBJECTIVE: To make a comparative analysis on the expedited approach for new drug review in the USA, the European Union, and Japan, and to provide references for China. METHODS: Through analyzing the mechanism and implementation performance of each expedited approach, and summarizing its characteristics, this paper puts forward some suggestions according to the situation of the reform for new drug review in China. RESULTS: Compared with the US, EU and Japan, our country is gradually laying emphasis on the value of clinical curative effect when to apply expedited approach, but there is still a large gap on system setting. CONCLUSION: Hence this paper suggests to draw lessons from foreign "multi-channel, full coverage" concept, and gradually to establish a new multi-channel system of expedited review approach on the basis of perfecting our country's priority review approach, thereby accelerating the process of new drugs which have high clinical value.