Recommendation on Pilot Work and Related Policies of Medicine Marketing Authorization Holder System in China

VernacularTitle:我国开展药品上市许可持有人制度试点工作情况及相关政策建议
Author: Huaiquan ZHAO
Keywords: Medicine marketing authorization holder system; Management; Pilot work
From: China Pharmacy 2017;28(4):433-436,437
CountryChina
Language:Chinese
Abstract: OBJECTIVE:To investigate and perfect the pilot work of medicine marketing authorization holder system in China. METHODS:The problems of medicine marketing authorization system in China and the features of medicine marketing licensing system in USA and EU were analyzed. The legal authority and content of pilot medicine marketing authorization holder system in China were summarized so as to propose related policy recommendation. RESULTS & CONCLUSIONS:There are many problems in the medicine authorization system in China which is the combination of“production license”and“marketing license”,for exam-ple,the obsolete definition of“new drugs”,the serious waste of drug resources,the insufficient research and development of new drugs. The“production license”and“marketing license”are separated in the USA and EU. There are many new drugs,high capaci-ty utilization and perfect system of drug safety,quality control and risk management. In order to ensure the effective implementa-tion of the pilot work,it is suggested to enhance and improve the quality authorization management,the pharmacovigilance system and drug injury relief related to drug safety management.