关键词: 上市许可持有人, 非生产企业, 权利, 义务

Abstract: Objective To explore the possibility of non-production enterprises to become the marketing authorization holder and its implementation path based on revision of the Drug Administration Law and marketing authorization holder (MAH) pilot program. Methods Through statistics of 1.1 class chemicals accepted by China Food and Drug Administration (CFDA) during August 2014 to August 2015, the basic situation of non-production enterprises listed applicants were analyzed, such as their nature, registration time and capital. As well, based on the rights and obligations stipulated in the MAH pilot program, the possibility of non-production enterprises to become the MAHs was analyzed. Results The non-production enterprises have accounted a large proportion in 1.1 class chemicals accepted by CFDA in nearly one year, the responsibility of drug safety and effectiveness will become a threshold for these enterprises to be MAHs. Conclusion To become MAHs, non-production enterprises should improve the quality management and monitoring departments. At the same time, our country still needs to improve MAH system, such as establishing the adverse drug event relief fund for compensation and other supporting policies to promise of smooth implementation for MAH pilot program.

Key words: marketing authorization holder, non-production enterprise, rights, obligation