我国现行药品进口备案制度分析

Research on the Legal System of Drug Import Filing

目的:梳理我国药品进口备案法规体系及相关管理,研究我国现行药品进口备案制度及存在的问题,为今后政策制定和优化提供文献参考。方法:运用文献研究和统计分析等方法,对现有药品进口备案管理制度进行深入研究,梳理药品进口备案中不同进口情形的法规文件及管理要求,找出存在的突出问题及争议点。结果与结论:当前药品进口备案工作中存在法规制度略显滞后、覆盖面相对较窄、种类繁杂、部分规定尚不够明确具体,首次进口品种的认定、准许证进口且无需口岸检验的药品是否需要备案存在争议,证件核验程序滞后、信息共享渠道不畅等问题。以上问题使得行政主体和相对人很难全面了解和正确把握相关法规制度,各口岸执行标准不统一,易影响进口药品市场供应,不利于建立统一、规范、高效的进口备案监管体系和营造良好的营商环境。针对存在的突出问题及争议点,提出完善规章制度、加强进口备案信息化建设等针对性建议。完善药品进口备案制度,能够提高药品进口备案工作的质量和效率,更好地为行政决策提供信息支撑、为政府服务提供信息指引、为事后监管提供管理线索。

Objective:To sort out the regulatory system and relevant management of drug import filing in China,study the current drug import filing system and existing problems in China,and provide literature reference for future policy formulation and optimization.Methods:Using the methods of literature research and statistical analysis to conduct in-depth research on the existing drug import filing management regulatory system,sort out the regulatory documents and management requirements for different import situations in the drug import filing,and find out the outstanding problems and disputes.Results and Conclusion:At present,there are some problems in the drug import filing work,such as slightly lagging laws and regulations,relatively narrow coverage,multifarious types,unclear and unspecific provisions,disputes over whether the first-time import is recognized,whether the drugs imported without port inspection need to be filed or not,lagging document verification procedures,and poor information sharing channels.The above problems make it difficult for the administrative subject and the counterpart to fully understand and correctly grasp the laws and regulations.Also,the implementation standards at various ports are not uniform,which is easy to affect the market supply of imported drugs,and is not conducive to establishing a unified,standardized and efficient import filing supervision system and creating a good business environment.Aiming at the outstanding problems and controversial points,this paper puts forward some pertinent suggestions such as perfecting regulations and strengthening the informatization construction of import record keeping.Perfecting the drug import filing system can improve the quality and efficiency of drug import filing,better provide information support for administrative decisionmaking,information guidance for government services,and management clues for post-event supervision.