ABSTRACT
This paper summarizes the current situation and existing problems of China's innovative drug market access policy from the basic aspects of innovative drug market access,such as intellectual property rights,drug pricing,medical insurance and bidding procurement.Based on the comprehensive analysis of Japan's innovative drug market access policy,through the comprehensive comparison of the two countries innovative drug market access policy differences,the paper put forward the practical measures to encourage the listing of innovative drugs in China,from the intellectual property rights,drug pricing,medical security and tender procurement in four areas.
ABSTRACT
Objective:Through reading a lot of literature on the critical path planning of FDA, analyzed the contribution and shortage of the critical path plan to China's medical device market access system.Methods: To analyze the critical path planning of FDA by using the method of literature review.Results: China should reference the critical path plan, reform the existing medical instrument market access system, improve the efficiency, simplify the procedure and promote the safety and development of the product.Conclusion: The research on the critical path planning of FDA is very important for the construction of China's modern medical device market access path.
ABSTRACT
OBJECTIVE:To discuss the necessity and rationality of drug manufacturing market access system in China and to introduce the economic value of which so as to provide references for its promotion and evolvement.METHODS:Model was built by applying regulation theory and the qualitative and quantitative investigation and analysis of which were carried out.RESULTS &CONCLUSION:Drug manufacturing market access system in China is essential,access control of which should be strengthened.