Setting Method Study of Data Protection Period for Biologics-Based on the Comparative Analysis of American and Japanese Methods / 中国药学杂志

OBJECTIVE: To compare the setting methods for biologics data protection period between America and Japan, in order to provide suggestions for China. METHODS: We made a contrastive study of American "break even" model and Japanese "risk management evaluation" model by using method introduction and characteristic analysis. RESULTS: The two setting methods in the US and Japan focus on different system objectives, respectively. The Chinese choice of setting method needs to combine the feasibility of setting methods and the national conditions and policy goals for comprehensive consideration. CONCLUSION: At present and the future for a long time, China's pharmaceutical industry is still in the "imitation to innovation" stage, and drug safety issues remain the core task. Therefore, the period of biologics data protection should be rationally set up by using "risk management evaluation" model as the base, "break even" model as supplement, so as to bring the three policy effects such as innovation incentive, the improvement of innovative drugs availability and strengthening the drug post-market safety monitoring.

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.