新时代药事管理制度改革研究及思考

Research and Thinking on the Reform of Pharmaceutical Administration System in the New Era

2009年,新一轮医改拉开帷幕,此后,“健康中国”战略与《“健康中国2030”规划纲要》等相继出台,标志着我国医药卫生体制改革的进程不断推进。随着医改不断释放改革动能,针对药品监督体制、药品流通管理、医疗卫生机构管理体制和运行机制等问题,通过不断更新完善药品管理政策法规,变革药品流通与支付方式,扩充医保用药目录,强化了药品监督能力、规范了药品流通市场、助推药品价格合理化,使民众切实感受到医改带来改变。医药和医保改革取得突破的同时,仍存在可改进空间。现阶段,药品上市许可持有人制度、药品流通、医保集采等方面仍存在问题。针对上述问题,提出了相应的改革建议,通过完善药品上市许可持有人制度的配套监管与两票制与集采的协同配合,合理调整医保带量集采目录等,以推动药事管理制度的革新与发展。同时加强信息化建设,以探求更高效的药事管理与更科学的药品改革方向,推进我国从制药大国到制药强国。

In 2009,a new round of medical reform kicked off,and since then,the"Healthy China"strategy and the"Healthy China 2030"Plan have been promulgated successively,marking the continuous advancement of the process of China's medical and health system reform.As the medical reform continues to release the momentum of reform,aiming at the problems of the drug supervision system,drug circulation management,and management system and operation mechanism of medical and health institutions,it continuously updates and improves drug management policies and regulations,changes the drug circulation and payment methods,expands the list of drugs under medical insurance,strengthens the drug supervision capacity,standardizes the drug circulation market,and promotes the rationalization of drug prices.So that people can actually feel the changes brought about by health reform.While breakthroughs have been made in medicine and healthcare reform,there is still room for improvement.At present,there are still problems in the holder system of drug marketing authorization,drug circulation and medical insurance collection.In response to the above problems,the corresponding reform suggestions were put forward to promote the innovation and development of the pharmaceutical management system by improving the supporting supervision of the drug marketing authorization holder system and the coordination between the two-vote system and the collection system,and rationally adjusting the catalogue of the collection of medical insurance.At the same time,we should strengthen the information construction to explore more efficient drug management and more scientific drug reform direction,and promote our country from a pharmaceutical power to a pharmaceutical power.