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目前我国药品上市许可制度对药品风险管理带来很多不利影响,本文从我国药品风险管理的角度分析我国实施MAH(Marketing Authorization Holder,药品上市许可人)制度对药品的研发和生产等环节带来的积极影响及将面临的问题,以期我国在实施MAH制度时,能规避风险,提高药品风险管理能力。
At present, the system of drug listing in our country brings a lot of adverse effects on the management of drug risks. This article analyzes the impact of implementing the system of MAH (Marketing Authorization Holder) on the R & D and production of drugs from the perspective of drug risk management in our country. Positive impact and problems that will be faced with the hope that China in the implementation of the MAH system, to avoid risks and improve drug risk management capabilities.