{"errCode":0,"errMsg":"success","timeStamp":"1780424050","data":{"trueId":"3746994889974610445","title":"【规范促提升  美业添活力 2022年国产普通化妆品备案情况解析】以问题为导向 发力提升备案质量","author":[],"tags":[],"detail":"\u003cp\u003e□ 李茜 何道慧 马燕\u003c/p\u003e\u003cp\u003e2021年，《化妆品监督管理条例》及其配套法规相继施行，化妆品注册备案信息服务平台上线运行。同年，为落实“放管服”改革要求，云南省药监局印发《关于进一步明确国产普通化妆品备案管理工作有关事项的通知》，明确全省各州（市）市场监管局负责辖区内国产普通化妆品备案人信息审核及备案资料整理工作，云南省药监局承担国产普通化妆品备案资料技术核查及全省化妆品备案质量抽查工作。\u003c/p\u003e\u003cp\u003e2022年，围绕对标新法规要求、适应新平台运行、理顺新工作机制，云南省药监局努力以问题为导向，多措并举防风险、提效能取得进展，云南省国产普通化妆品备案工作平稳过渡。\u003c/p\u003e\u003cp\u003e找准影响监管效能问题\u003c/p\u003e\u003cp\u003e2022年，云南省办理国产普通化妆品备案4142件次。其中，首次申请1130件次、变更申请454件次、注销申请1226件次、信息补录1332件次。国产普通化妆品备案办理总量较上年度增长约48%；完成备案技术核查819件次。\u003c/p\u003e\u003cp\u003e云南省化妆品企业多为中小型企业，专业技术、法务等人才较发达地区相对匮乏，备案一次性通过率较低，这在增加监管风险的同时，也对有限的行政资源造成浪费。经汇总梳理，以下三个方面问题较为常见。\u003c/p\u003e\u003cp\u003e一是化妆品备案人对法规要求理解不到位，提交的备案资料内容表述不精准，出现备案申请表填报不准确、产品名称命名依据不充分等问题。比如，产品的实际作用部位为脸部和颈部，但在勾选分类编码时仅选择了面部；对于驻留类产品，在勾选分类编码时选择了淋洗类；未分别说明产品商标名、通用名、属性名的具体含义等。\u003c/p\u003e\u003cp\u003e二是存在提交备案的研究资料不完整、适用性证据单薄等情况。比如，产品执行的标准中，微生物和理化指标以非检验方式作为质量控制措施的，未明确提供具体的实施方案及合理性说明；产品安全评估资料中，对于部分原料未开展风险识别及评估、风险评估结论缺乏适用性证据等。\u003c/p\u003e\u003cp\u003e三是与注册申报相比，备案人对备案事项的重视程度不够，在填报原料、标签、检验报告等内容时校对审核不严，频繁出现信息填报失误和漏填等情况。比如，未填报原料生产商和商品名信息，或检验报告中产品名称、生产企业地址、净含量等信息与在备案平台上填报的不一致等。\u003c/p\u003e\u003cp\u003e同时，在新法规要求、新工作机制下，在备案资料整理、技术核查过程中，还存在部分监管人员对法规理解把握不准、审核标准尺度不统一等问题。\u003c/p\u003e\u003cp\u003e系统提升备案管理能力\u003c/p\u003e\u003cp\u003e围绕国产普通化妆品备案工作中的高发问题和不足，云南省药监局着眼长治长效，健全完善制度机制，持续提升备案管理能力。\u003c/p\u003e\u003cp\u003e加强风险源头闭环管理。通过制定《云南省化妆品安全高风险信息“直通车”检查办法（试行）》，明确省级药监部门定期汇总备案资料技术核查中发现的涉嫌风险或违规问题，经风险研判后移交监督检查、监测评价及稽查执法等部门。2022年，通过提示风险、构建闭环，经延伸检查，共对12个产品的备案人下达责令改正并暂停生产销售的行政措施，对1个产品取消备案。\u003c/p\u003e\u003cp\u003e加快构建全省化妆品备案工作“一盘棋”格局。云南省药监局在加强对全省州（市）市场监管局业务培训指导的基础上，建立国产普通化妆品备案质量定期抽查机制，突出典型问题，明确审查标准，发布云南省国产普通化妆品备案质量抽查工作情况通报两期；同时，充分发挥考核指挥棒作用，将质量抽查、完成时限等指标纳入年度药品安全考核；全省备案资料审查标准和尺度得到进一步统一，备案资料审查质量和效率得到进一步提升。\u003c/p\u003e\u003cp\u003e寓服务于监管。云南省药监局实施“一企一策”，对产品量大面广的重点企业主动提供上门服务，提供有针对性的法规及技术指导，确保备案信息合规、真实、准确；发布“云妆”备案小贴士4期，通过案例展示备案审查中发现的高频问题，以点带面规范引导全省化妆品备案资料提交；设置企业咨询接待日，畅通线上线下咨询服务渠道，点对点开展帮扶指导，全年服务企业100余家次。\u003c/p\u003e\u003cp\u003e今年，云南省药监局先后组织人员赴广东省、山东省等化妆品产业发展和监管先进地区学习经验，以期在新法规实施平稳过渡后，加快对标一流步伐，通过构建系统完备的管理体系、探索数据赋能的智慧监管、提升质效并重的审查能力、优化精准靶向的服务引导，全力保障人民群众用妆安全。\u003c/p\u003e\u003cp\u003e（作者单位：云南省药品和医疗器械审评中心）\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003ch4\u003e\u003c/h4\u003e","createdAt":1691632132,"updatedAt":1691632134,"source":0,"reprintedUrl":"http://bk.cnpharm.com/zgyyb/2023/08/10/319835.html","type":0,"vShowStyle":0,"transCodingObjKey":"https://img.hubpd.com/hubpd/64d44206cb6d0600013fa483","transCodingObjKeyMp4":"https://img.hubpd.com/hubpd/","mpIcon":"https://img.hubpd.com/hubpd/ad28ec10-c530-11ec-be45-ce7461699b21.png","mpName":"中国医药报","mpIsVerified":true,"mpId":"60209","covers":[],"coversType":0,"blurImage":"","publishedAt":1691596800,"classificationName":"社会","tap":2013,"likeCnt":0,"userIsLike":false,"isFeedAd":false,"compositeId":"3746994889974610445|0|0","editedAt":0,"mpLinkType":0,"mpLinkTypeList":[],"coverType":0,"settled":0,"settledEntity":"","settledInfo":"","hideView":0,"hideLike":0},"hisHots":{"hotData":[{"trueId":"288230376156628995","title":"药品追溯体系建设政策专题会在京召开 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