Mechanism Study on Risk Sharing and Transfer of Drug Marketing Authorization Holders Based on Drug Defects / 中国药房

ABSTRACT

OBJECTIVE：To explore the mechanism of risk sharing and transfer of drug marketing authorization holders （MAH）based on drug defects ，and to promote the smooth implementation of MAH system in China. METHODS ：Firstly，the types of drug defects in the whole drug life cycle were analyzed ，and then the sources and “fault party ”of different types of drug defects in the open commissioning environment of the industry chain under the MAH system were also analyzed. Based on it ，the mechanism of risk sharing and transfer of MAH was established combined with foreign experience and China ’s actual situation. RESULTS & CONCLUSIONS ：Drug defects were divided into design defects ，manufacturing & operation & storage & transportation quality defects and use defects ，among which design defects and manufacturing & operation & storage & transportation quality defects were the two most important defects. Design defects mainly included those caused by human factors and those could not be found by current level of science and technology ，the“fault party ”according to different circumstances may be both the research and development institutions and may be the MAH. The “fault party ”of production & operation & storage & transportation quality defects was the drug production & operation & storage & transportation enterprises. For design defects ，it was recommended to establish China ’s adverse drug reaction compensation mechanism through a combination of insurance and relief. For production & operation & storage & transportation quality defects ，it was recommended that the drug quality liability insurance as the main ，contractual agreement as the supplement ，so that the “fault party ”should assume due responsibility.