Asian Journal Of Social Pharmacy

Abstract: Objective To study the situation of new drug registration for biological products from 2010 to 2015 in China. Methods Information of new drug registration for biological products from 2010 to 2015 in China was collected and classified and development trend was made from several aspects: the total number of new drug registration application, application types, drug types and registration classification. Results and Conclusion New drug research and development of biological products in China showed a trend of rapid growth. At the same time, the innovation level of new drug research and development of biological products was improved. China has made a great achievement in monoclonal antibody research and development.

Key words: biological products, new drug registration, analysis