我国药品广告监督管理的现状与特点

Analysis of Status Quo and Characteristics of Drug Advertisement Supervision in China

目的:为国家食品药品监督管理部门加强药品广告监管工作提供参考。方法:收集2006-2016年国家食品药品监督管理部门统计年报以及2013年和2015年《中国食品药品监督管理统计年鉴》中省(区、市)层面数据,采用对比分析、定量分析等方法对药品广告批准、药品广告批准文号撤销、向工商行政部门移送违法药品广告件数以及药品广告异地备案件数等数据进行分析。结果与结论:全国药品广告批准数量由2006年的35 530件下降至2016年的30 027件,除个别年份有小幅度增长外整体处于下降态势;大部分年份全国撤销违法药品广告批准文号的数量基本稳定在100件以内,但各省(区、市)间差异较大;向工商行政部门移送违法药品广告件数呈现先上升,自2014年后下降的趋势,各省(区、市)移送违法药品广告占批准总数的比例差异很大;2015年,18个省(区、市)药品广告异地备案数量占药品广告批准数量的比例高于全国平均水平(69.87%)。建议相关部门逐步试点取消药品广告异地备案制度,建立完善的药品广告事前审查制度,强化与工商行政部门的协调合作,细化药品广告审批与查处分项统计指标,逐步完善我国药品广告的监管工作。

OBJECTIVE:To provide reference for strengthening drug advertisement supervision in departments of food and drug administration.METHODS:The annual statistical reports were collected from departments of food and drug administration during 2006-2016,and the level of province data of Statistical Yearbook of China Food and Drug Administration were also collected in 2013 and 2015.Comparative analysis and quantitative analysis were used to analyze drug advertising approval,revocation of drug advertisement registration approved number,disclosing illegal drug advertisements to industrial and commercial administrative departments and off-site record of drug advertising.RESULTS&CONCLUSIONS:The number of national drug advertising approval decreased from 35 530 in 2006 to 30 027 in 2016,and showed a downward trend on the whole except for a small increase in a few years.The number of revocation of national illegal drug advertisement was basically within 100 in most years;but there was a significant difference between provinces(regions,cities).The number of illegal drug advertisement transferred to industrial and commercial administration departments rose first and then declined since 2014;there was great difference in the proportion of illegal drug advertisement in total number of approved advertisement among the provinces(regions,cities).The proportion of the number of off-site record of drug advertisement in the number of drug advertisement approval in 18 provinces(regions,cities)was higher than national average(69.87%)in 2015.Relevant departments are suggested to gradually abolish off-site record system of drug advertisement,establish prefect drug advertisement review in advance system,strengthen cooperation with industrial and commercial administrative departments,refine statistical indexes of drug advertisement approval and examination,and improve drug advertisement supervision gradually.