省级药品监管部门机构改革状况研究——从内设机构设置的角度

Research on Institutional Restructuring of Provincial Drug Regulatory Agencies--from the Perspective of Internal Organization Setting

从内设机构设置的角度,对30个省(自治区、直辖市)药监局内设机构的数量和分类进行共性、差异性、特殊性分析。发现各省(自治区、直辖市)药监局内设机构数量相差大,平均值为10.5个,行政职能处室均占比较小,均有“两品一械”处室设置,处室细分设置差异性较大,部分有民族药监管处和应急管理处单独设置。新修订《药品管理法》明确了药品监管部门、地方政府以及监管人员的义务与责任,各省(自治区、直辖市)药品监管部门应规范职能划分、重视应急管理、均衡处室数量、创新设置思维,以机构深化改革为契机,谋求属地监管纵深发展。

From the perspective of internal organization setting,this paper analyzed the commonness,difference and particularity of the number and classification of internal organization in 30 provincial drug regulatory agencies.The study found that the number of internal organizations within provincial drug regulatory agencies varies greatly,with an average of 10.5,and the proportion of administrative departments were relatively small.All provincial drug regulatory agencies had set up medicine,cosmetic and medical device departments.There were significant differences in division setting.And part of them had set up traditional medicine regulatory and emergency management departments.The latest amended Drug Administration Law clarified the obligations and responsibilities of drug regulatory agencies,local governments and regulators.Provincial drug regulatory agencies should standardize their internal functional division,emphasize emergency management,balance the number of departments,innovate the setting thinking,and take the opportunity of deepening institutional restructuring to seek the in-depth development of territorial supervision.