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  • 山西省太原市杏花岭区局“铁腕”监管筑牢药品安全防护网

    为切实规范药品经营行为,守护辖区群众用药安全,近日,太原市杏花岭区市场监管局聚焦执业药师在岗、“回流药”排查、明码标价等关键环节,开展药店监督检查,用“铁腕”监管筑牢药品安全防护网。监督检查重点核查药店是否在营业期间按规定配备执业药师,药师是否在岗履职、是否规范开展处方审核与用药咨询服务,对药师注册信息、在岗公示情况等进行细致检查;深入排查药店药品进货渠道,重点核查药品采购记录、验收台账、储存条件等,严厉打击从非法渠道购进药品、销售过期药品、篡改药品有效期等违法行为。同时,向药店经营者普及“回流药”危害及法律后果,督促药店严格执行药品追溯制度,从源头杜绝“问题药”流入消费者手中,切实斩断非法药品流通链条。检查中,执法人员对药店药品标价签是否规范、价格信息是否清晰完整、是否存在“阴阳价”“哄抬药价”等行为进行全面检查。要求药店对所有药品实行“一药一价签”,清晰标注药品名称、规格、单价等信息,确保消费者购药时“看得懂、算得清”。药品安全无小事,监管责任大于天。杏花岭区局将持续加大对辖区药店监督检查力度,通过“日常检查+突击抽查+回头看”相结合的方式,常态化筑牢药品安全防线,让“放心药”走进千家万户。

    法规 / 其它 / 药品 山西省
  • Yangzhou H&R Plastic Daily Chemical Co., Ltd.(320-26-54)

    Delivery Method:Via Electronic Mail - Return Receipt RequestedReference #:320-26-54Product:DrugsRecipient:Mr. Jingcheng GaoGeneral ManagerYangzhou H&R Plastic Daily Chemical Co., Ltd.188 Xingyuan RoadHangjiGuangling QuYangzhou ShiJiangsu Sheng,225111ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-54March 18, 2026Dear Mr. Gao:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Yangzhou H&R Plastic Daily Chemical Co., Ltd., FEI 3014543859, at 188 Xingyuan Road, Hangji, Guangling, Yangzhou, Jiangsu, from October 21 to 24, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We have not received a response from your firm stating your actions to address the deficiencies identified during the inspection and cited on our Form FDA 483. We note that you continue to ship drug products to the United States.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).Your firm contract manufactures an over-the-counter(b)(4)drug product. You failed to adequately test batches of your finished drug product for the identity and strength of your active ingredient (e.g.(b)(4)) before release and distribution. Your specification procedures only discuss appearance, color, and weight checks prior to batch release.Full release testing, which includes strength and identity testing of the active ingredient, must be performed before drug product batch release and distribution. Without adequate testing, you do not have adequate scientific evidence to assure that drug product batches conform to appropriate specifications before release.In response to this letter, provide:A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.2. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).Your firm failed to conduct adequate identity testing on incoming components, including active pharmaceutical ingredients, used in the manufacturing of your drug products. Additionally, you relied on your suppliers’ certificates of analyses (COA) without establishing the reliability of each of your component suppliers’ analyses at appropriate intervals.Without adequate testing and confirmation of reliability of supplier test results, you lack scientific evidence that the components conform to appropriate specifications prior to use in the drugs products you manufacture.In response to this letter, provide:A comprehensive, independent review of your material system, including but not limited to:o evaluating all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualified;o an assessment of all materials to determine whether they are consistently of acceptable quality;o a review to ensure assigned expiration or retest dates are appropriate (supported by data);o adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions.Based on a thorough review, provide a summary of your systems corrective actions and preventive actions to remediate the vendor qualification program and prevent use of unsuitable components, containers and closures.The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure that describes this COA validation program.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.3. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).Your firm failed to adequately qualify the equipment and validate the processes used to manufacture your(b)(4)drug product. You have not performed process performance qualification (PPQ) studies, nor do you have a meaningful ongoing program for monitoring process control, to ensure stable manufacturing operations and consistent drug quality.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately to ensure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies determine whether an initial state of control has been established. Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality are necessary to ensure that you maintain a stable manufacturing operation throughout the product lifecycle.See FDA’s guidance document for general principles and approaches that FDA considers appropriate elements of process validation, at https://www.fda.gov/media/71021/download.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program forprocess performance qualification, and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing appropriate PPQ for each of your marketed drug products. Also provide a risk assessment and any follow up actions to be taken for the distributed drug products produced without performing any process validation studies.Process performance protocol(s), and written procedures for qualification of equipment and facilities.A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.4. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).Your firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacture of drug products. For example, you failed to ensure:Adherence to an adequate stability program (21 CFR 211.166(a)).Consistent and complete batch records (21 CFR 211.188).Appropriate examination of labeling and packaging materials for correctness, including but not limited to sufficiently accounting for all ingredients used in manufacturing, prior to packaging operations (21 CFR 211.130(d)).There was a fundamental failure of production management to effectively oversee the procedures, practices, and suitability of the manufacturing operations. In addition, even when a QU consists of one or only a few, those persons are still accountable for overseeing ongoing effectiveness of all systems and procedures, and review of the results of manufacture to ensure state of control and adherence to all quality standards.In response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriate.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o A complete and final review of each batch and its related information before the QU disposition decision.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.Quality SystemsYour firm’s quality systems are inadequate. See FDA’s guidance documentICH Q10 Pharmaceutical Quality System, as well asQuality Systems Approach to Pharmaceutical CGMP Regulations, for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71553/download and https://www.fda.gov/media/71023/download, respectively.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on February 13, 2026.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at 188 Xingyuan Road, Hangji, Guangling, Yangzhou, Jiangsu, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3014543859 and ATTN: Philip Kreiter.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

    法规 / 其它 / 药品 全国
  • 广东出台三年行动方案 推动化妆品产业从规模领先向质量引领跨越

      近日,省药品监督管理局正式发布《广东省化妆品企业生产质量管理体系提升三年行动方案(2026—2028年)》,旨在全面推动全省化妆品产业高质量发展,助力广东从“规模领先”向“质量引领”“创新驱动”跨越,打造化妆品制妆强省和品质标杆。  到2028年底,计划力争实现四大核心目标:企业主体责任意识全面增强,关键岗位人员履职能力大幅提升;企业质量体系运行水平整体提升,风险防控能力显著增强;产业质量基础更加稳固,标杆企业带动产业链协同进步;监管服务能力持续优化,多方参与的社会共治格局基本形成,切实守护群众用妆安全与权益。  为落实目标,计划部署三大方面的16项重点任务与落实举措:精准施策助力企业质量体系提档升级,梳理行业共性问题,完善“三位一体”质量提升机制,建立三级责任体系与全员培训机制,提升关键岗位人员履职能力,强化质量安全风险防控能力;优化环境促进化妆品产业高质量发展,优化生产质量管理制度,提升质量体系监管效能,培育美妆头部企业与国际知名品牌,全力支持广州“国际美湾”建设,扩大“广州国际美妆周”影响力,依托大湾区科研资源推动技术创新,推广标杆企业经验,基本形成社会共治格局;赋能发展推动监管部门服务效能提升,推行分级分类监管,完善检查标准,全力构建化妆品全链条智慧监管体系,加强监管队伍专业化建设,变事后查处为事前服务。  该计划的实施,将全面提升广东化妆品产业整体质量水平,破解行业发展痛点,为全国化妆品产业高质量发展与监管创新提供广东实践,助力粤妆品牌走向国际市场。(省局化妆品监管处供稿)

    法规 / 其它 / 化妆品 广东省
  • 北京市关于2025年度无逾期未支付中小企业款项情况的公示

      根据《保障中小企业款项支付条例》(国务院令第802号)第十八条规定,现将我局2025年度支付中小企业款项有关情况公示如下:  2025年度,北京市药品监督管理局严格落实保障中小企业款项支付相关要求,无逾期未支付中小企业款项情形。  特此公示。  北京市药品监督管理局  2026年3月23日

    法规 / 其它 / 药品 北京市
  • 国家药监局关于暂停进口、销售和使用Vasudha Pharma Chem Limited盐酸洛哌丁胺原料药和Alchem International Private Limited 利血平、地高辛原料药的公告(2026年第31号)

      近期,国家药监局组织对Vasudha Pharma Chem Limited盐酸洛哌丁胺原料药(登记号:Y20170000816;生产地址:1. Plot No.37/A, 38, 39A&B, Phase-I, IDA, Jeedimetla, Hyderabad-500055, Telangana,India; 2. Plot No.23&24, Jawaharlal Nehru Pharma City, Thanam(V), Parawada(M) Anakapalli District-531019, Andhra Pradesh,India),Alchem International Private Limited利血平原料药(登记号:Y20190009266、Y20190009267;生产地址:1. 25/2 Main Mathura Road, Village Kaili, Ballabgarh, Faridabad - 121004, Haryana, India; 2. SP 2-5,RIICO Industrial Area,Neemrana,Alwar-301705,Rajasthan,India)和地高辛原料药(登记号Y20190009119、Y20190009120;生产地址:25/2 Main Mathura Road, Village Kaili, Ballabgarh, Faridabad - 121004, Haryana, India)开展现场检查。  经查,在上述原料药生产过程中,相关企业存在未按注册批准内容生产、变更未按规定及时报批或备案等情形,不符合我国《药品生产质量管理规范(2010年修订)》及附录有关要求。  根据《中华人民共和国药品管理法》第九十九条、《药品医疗器械境外检查管理规定》第三十条等有关规定,国家药监局决定,自即日起:  一、暂停进口上述原料药,各口岸药品监督管理部门暂停发放上述原料药产品的进口通关单。  二、上述原料药在国家药监局药品审评中心“原辅包登记信息”中“与制剂共同审评审批结果”调整为“I”(即未通过与制剂共同审评审批)。  三、上述原料药不得在境内销售、不得用于药品制剂生产,对已使用上述原料药生产的制剂不得放行;已上市放行的制剂,药品上市许可持有人应当立即开展调查与评估,并根据评估结果采取必要的风险控制措施。  特此公告。国家药监局2026年3月23日

    法规 / 其它 / 药品 全国
  • 湖北省武汉分局强化医疗器械集采中选产品质量监管

    为深入贯彻落实国家药监局及省药监局关于医疗器械集采中选产品质量监管的工作部署,武汉分局落实“四个最严”要求,将集采中选生产企业纳入重点监管范围,通过系统谋划、精准施策、压实责任,切实保障人民群众用械安全。一、明确“三个重点”,监管思路更清晰武汉分局紧扣省局医疗器械监管工作主线,制定年度重点检查方案,明确“突出重点企业、突出重点环节、突出重点产品”的工作思路。针对无菌和植入类、集中带量采购中选、医疗美容类以及仅委托和受托医疗器械生产企业,分局重点检查企业质量管理体系建立和运行情况。通过精准定位监管重点,2026年一季度共检查医疗器械生产企业94家次,发现风险隐患200余项,已督促企业完成整改138项,整改完成率近70%,实现检查与整改闭环管理。二、摸清监管底数,风险防控更精准结合日常监管掌握情况,分局系统梳理辖区内集采中选生产企业并动态更新产品品种信息,确保监管底数清晰、心中有数。截至目前,辖区内参加国家集采、省际联盟集采和省级独立集采的注册人中选企业共28家,涉及第二、三类医疗器械品种322个。其中国家集采企业3家、品种26个,其余为省际联盟及省级独立集采中选品种。通过对监管对象的全面画像,分局实现了对重点品种的精准监管和风险预警,为后续靶向抽检和监督检查奠定了坚实基础。三、压实主体责任,质量意识再提升分局坚持以普法为先导,强化企业主体责任意识。一季度,已向企业发放医疗器械生产GMP手册100余本,辅导督促企业完成质量管理体系年度自查报告填报。截至目前,辖区内376家医疗器械生产企业已全部在线上提交自查报告。通过自查自纠与监督指导相结合,企业质量安全意识得到有效提升,质量管理体系运行更加规范。四、强化抽检监测,全链条监管更有力下一步,武汉分局将聚焦列入国家抽检任务的16个品种45批次产品,结合国家局下发的《2026年第六批国家集采医疗器械抽样方案》,细化分解任务指标,以国家集采品种、无菌、植入、医美类等重点类别产品为重点,全面提升抽检的针对性和有效性。同时,分局将持续加大集采中选医疗器械生产企业的监管力度,依托不良事件监测系统,加强对集采中选产品的风险信号监测,及时发现和处置质量安全风险,实现全链条闭环监管,牢牢守住医疗器械质量安全底线。(信息来源:武汉分局)

    法规 / 其它 / 医疗器械 湖北省
  • 四川省关于公示医用耗材申报企业变更境外生产企业信息的通知(川药招〔2026〕55号)

    相关医药机构,相关企业:根据《关于做好医药机构医用耗材集中采购工作的通知》(川药招〔2021〕66号)及《关于做好近期药械产品分类采购申报相关工作的补充通知》(川药招〔2021〕112号)等文件要求和工作安排,现将医用耗材(含体外诊断试剂)申报企业申请变更境外生产企业信息进行公示,有关事项通知如下:一、公示时间2026年3月24日至2026年3月26日。二、公示范围及内容截至2026年3月20日,在四川省药械集中采购及医药价格监管平台提交境外生产企业变更的申请信息。公示内容包含变更前后境外生产企业名称、前后境外生产企业授权书等,公示的图片信息仅用于产品公示,不得转为其他用途,相关内容(详见附件)。三、质疑要求公示期间,如对公示内容有异议,须由有利益关系的潜在供应商实名提出,按质疑函件规范模板线上提交(模板见系统内质疑投诉模块)。不满足质疑函件规范形式要件、证明材料无相关佐证资料等情况不予受理。线上质疑相关操作程序详见系统内帮助文档。线上质疑链接:https://ggfw.scyb.org.cn咨询电话:028-86917838028-85157579附件:1.耗材境外生产企业信息变更 2.试剂境外生产企业信息变更四川省药械招标采购服务中心 2026年3月24日

    法规 / 其它 / 医疗器械 四川省
  • 广东出台三年行动计划 推动化妆品产业从规模领先向质量引领跨越

      近日,省药品监督管理局正式发布《广东省化妆品企业生产质量管理体系提升三年行动计划(2026—2028年)》,旨在全面推动全省化妆品产业高质量发展,助力广东从“规模领先”向“质量引领”“创新驱动”跨越,打造化妆品制妆强省和品质标杆。  到2028年底,计划力争实现四大核心目标:企业主体责任意识全面增强,关键岗位人员履职能力大幅提升;企业质量体系运行水平整体提升,风险防控能力显著增强;产业质量基础更加稳固,标杆企业带动产业链协同进步;监管服务能力持续优化,多方参与的社会共治格局基本形成,切实守护群众用妆安全与权益。  为落实目标,计划部署三大方面的16项重点任务与落实举措:精准施策助力企业质量体系提档升级,梳理行业共性问题,完善“三位一体”质量提升机制,建立三级责任体系与全员培训机制,提升关键岗位人员履职能力,强化质量安全风险防控能力;优化环境促进化妆品产业高质量发展,优化生产质量管理制度,提升质量体系监管效能,培育美妆头部企业与国际知名品牌,全力支持广州“国际美湾”建设,扩大“广州国际美妆周”影响力,依托大湾区科研资源推动技术创新,推广标杆企业经验,基本形成社会共治格局;赋能发展推动监管部门服务效能提升,推行分级分类监管,完善检查标准,全力构建化妆品全链条智慧监管体系,加强监管队伍专业化建设,变事后查处为事前服务。  该计划的实施,将全面提升广东化妆品产业整体质量水平,破解行业发展痛点,为全国化妆品产业高质量发展与监管创新提供广东实践,助力粤妆品牌走向国际市场。(省局化妆品监管处供稿)

    法规 / 其它 / 化妆品 广东省
  • 海南省药监局联合多部门部署开展清源巩固提升行动,纵深推进药品安全监管与群腐整治工作

    为深入贯彻落实国家局药品上市后监管工作部署,持续巩固药品经营环节“清源”行动成效,全面提升药品流通监管与稽查执法效能,3月20日,海南省药品监督管理局组织召开全省药品经营环节清源巩固提升行动工作培训部署会。全省各市县药品监管部门、执法机构及相关单位负责人、业务骨干参加会议。省纪委监委驻省市场监管局、省知识产权局纪检监察组组长马建东,省公安厅环食药侦总队副总队长莫正传和禁毒总队相关同志在主会场参加会议。省药监局副局长陈俊杰主持会议并讲话。会议总结2025年药品流通监管工作,聚焦清源巩固提升、稽查办案、肉毒毒素专项整治等重点工作,系统部署2026年重点任务,并对进一步提升政治站位,协同推进药品领域整治群众身边不正之风和腐败问题等工作提出明确要求。会议全面梳理药品经营环节监管成效、风险隐患与存在问题,肯定2025年清源行动在规范渠道、打击违法、防控风险等方面取得的阶段性成果,对2026年药品经营环节清源巩固提升行动作出专项部署。明确以源头治理、全程管控、数字赋能为核心,紧盯购进渠道、储存养护、处方销售、追溯管理、执业药师在岗履职等重点环节,强化全链条监管与风险排查,推动企业主体责任落实,严防非法渠道购销、假劣药品流入市场,持续净化药品经营市场秩序。会议对2026年稽查办案工作作出系统安排,要求坚持严查重处、以案促治,健全线索发现、案件查办、行刑衔接机制,提升执法规范化与专业化水平;强化稽查执法刚性,聚焦群众反映强烈的突出问题,加大重点领域、重点品种案件查办力度;加强跨区域协同与部门联动,提升执法震慑力,做到有案必查、查案必严、违法必究。会议对肉毒毒素专项整治工作作出专门部署,强调注射用A型肉毒毒素作为特殊管理药品,事关公众健康与医美安全。要聚焦经营、使用全环节,严查非法购销、渠道不合规、追溯不到位、使用不规范等行为,强化医美机构、药品经营企业监督检查,压实追溯管理与进货查验责任,严厉打击制售假劣肉毒毒素等违法犯罪,保障特殊药品监管安全。会议对整治群众身边不正之风和腐败问题提出要求,强调要坚持严的基调不动摇,将整治与药品监管、稽查执法、清源巩固提升行动深度融合。明确开展药品经营环节“清源”巩固提升行动,不仅是国家部署的硬性任务,也是自贸港封关运作的基础保障,是回应群众急难愁盼的民生工程。全省药品监管部门要以“清源”护安全,斩断非法链条,清除风险源头;要以“巩固”强基础,固化专项整治成果,健全长效机制;要以“提升”促效能,推进智慧监管、协同监管、精准监管,实现药品经营来源可查、去向可追、责任可究,持续筑牢药品安全防线,切实保障人民群众用药安全有效。供稿:药品流通处

    法规 / 其它 / 药品 海南省
  • 山西省娄烦县局深入开展药品网络销售监督检查

    为进一步规范辖区药品网络销售行为,保障公众用药安全,近期,娄烦县综合行政执法局组织开展药品网络销售监督检查。周密部署,明确检查重点。本次行动制定详细的检查计划,聚焦药品网络销售关键环节和重点风险点开展监督检查。检查内容涵盖药品网络销售企业是否严格履行报告义务,入驻平台资质手续是否完备,药品购进渠道是否合法合规,线上线下库存是否保持一致,实际发货地址与经营场所是否相符,网售处方药处方来源是否规范,网页展示内容是否符合规定,以及是否存在销售禁售目录药品等情况。精准发力,全面排查隐患。执法人员采用线上监测与线下实地检查相结合的方式,对辖区内药品网络销售企业进行全面细致检查。检查过程中充分运用数据分析、药品追溯系统等技术手段,精准定位可能存在的问题。重点筛查销售禁止网络零售药品、网页违规展示处方药、网售价格异常低于市场价格等风险隐患。管宣并重,督促整改落实。执法人员本着监管与宣传教育相结合的原则,检查过程中对药品网络销售企业相关人员进行宣传教育及警示引导,督促其切实增强守法意识、诚信意识和责任意识。截至目前,共检查药品网络销售企业11家,下达责令改正通知书3份,相关企业已全部完成整改。娄烦县局将建立健全长效监管机制,持续开展药品网络销售风险监测和监督检查工作,切实保障公众用药安全。

    法规 / 其它 / 药品 山西省
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