获益与风险视角下的地标中药饮片跨省流通监管问题分析 点击下载
| 论文标题： | 获益与风险视角下的地标中药饮片跨省流通监管问题分析 |
| 英文标题： | |
| 中文摘要： | 目的 为解决我国执行地方标准的中药饮片（以下简称“地标中药饮片”）跨省流通的争议问题提供思路。方法通过模拟场景和收集实际案例，列举我国地标中药饮片跨省流通的几种情形，检索官方网站或访谈药品监管相关人员，梳理我国地标中药饮片跨省流通监管现状，并基于利益相关者理论探讨相关主体的获益与风险，从获益、风险平衡的视角提出相关政策建议。结果与结论我国地标中药饮片跨省流通大致可分为3种情形：外省企业按照本省地标生产饮片并流通至本省销售使用、外省企业按照生产企业所在省地标生产饮片并流通至本省销售使用、外省企业按照第三省地标生产饮片并流通至本省销售使用。目前国家尚无法律性文件明确统一对地标中药饮片跨省流通问题的监管要求，地方监管意见主要来源于药品监管部门官网对在线咨询的回复，仅山东、上海、辽宁、江西发布了复函或规范性文件。分别有41.9％、38.7％、32.3％的省份允许上述3种情形的地标中药饮片跨省流通；另还有32.3％、16.1％、22.6％的省份对上述3种情形的监管态度尚不明确。相关利益主体的获益和风险分析显示，有条件地允许地标中药饮片跨省流通更符合获益、风险平衡的科学监管理念，但监管效果取决于监管策略的科学性。建议药品监督管理部门厘清中药饮片国家标准和地方标准的关系，差异化收载品种；出台较高层级的法律文件，明确地标中药饮片跨省销售的监管要求；丰富监管措施和手段，逐步调整地标中药饮片的跨省流通要求。 |
| 英文摘要： | OBJECTIVE To provide ideas for solving the dispute of trans-provincial distribution of traditional Chinese medicine （TCM） decoction pieces in accordance with provincial standards （hereinafter referred to as “local TCM decoction pieces”）. METHODS Through simulation scenarios and collecting actual cases ，the conditions of trans-provincial distribution of local TCM decoction pieces were listed ；the official websites were searched or relevant personnel of drug supervision were interviewed；the current situation of trans-provincial distribution supervision of local TCM decoction pieces in China were sorted out. Based on the stakeholder theory ，the benefits and risks of main stakeholders were discussed to put forward relevant suggestions from the perspective of benefit /risk balance. RESULTS & CONCLUSIONS The conditions of trans-provincial distribution of local TCM decoction pieces in China included enterprises in B province produced TCM decoction pieces according to the A provincial standards，sold and used them in A province ；enterprises in B province produced TCM decoction pieces according to the B provincial standards ，sold and used them in A province ；enterprises in B province produced TCM decoction pieces according to the C provincial standards ，sold and used them in A province. At present ，there are no clear relevant provisions of national laws about trans-provincial distribution supervision of local TCM decoction pieces. Local regulatory opinions mainly come from the reply of the official website of drug regulatory department to online consultation ，and only Shandong ，Shanghai，Liaoning and Jiangxi have issued replies or normative documents. Totally 41.9％，38.7％ and 32.3％ of the provinces respectively allow the trans-provincial distrbution of local TCM decoction pieces in the above 3 conditions；in addition ，32.3％，16.1％ and 22.6％ provinces have unclear regulatory attitudes towards the 3 conditions. The benefits and risks analysis of relevant stakeholders shows that it is more in line with the scientific regulatory concept of benefit/risk balance to conditionally allow trans-provincial distribution of local TCM decoction pieces ，but the regulatory effect depends on the scientificity of the regulatory strategy. It is suggested that the drug regulatory departments clarify the relationship between the national and local standards for TCM decoction pieces and dingrl375@163.com differentiate the varieties of collection ；clear the regulatory requirements for trans-provincial distribution of local TCM decoction pieces by issuing high-level legal d ocuments；enrich regulatory measures and means ，and gradually adjust the requirements of trans-provincial distribution of local TCM decoction pieces . |
| 期刊： | 2022年第33卷第16期 |
| 作者： | 丁瑞琳，蒋蓉，邵蓉 |
| 英文作者： | DING Ruilin，JIANG Rong，SHAO Rong |
| 关键字： | 药品监管；地方标准；炮制规范；中药饮片；跨省流通；利益相关者 |
| KEYWORDS： | drug regulation ；provincial standards ；processing specifica tion；traditional Chinese medicine decoction pieces ； |
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