Setting Method Study of Data Protection Period for Biologics-Based on the Comparative Analysis of American and Japanese Methods
- Author:
Xue-Fang YAO
1
Author Information
- Publication Type:Journal Article
- Keywords: Biologics; Data protection period; Japan; Setting method; The US
- From: Chinese Pharmaceutical Journal 2017;52(10):891-896
- CountryChina
- Language:Chinese
- Abstract: 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.
