2025年以来，全省各级药品监管部门紧扣“四个最严”要求，以守护人民群众生命健康为核心使命，持续加大监管执法力度。先后查处多起性质恶劣、社会影响较大的违法违规案件，有效净化了药品市场环境，切实保障了人民群众身体健康与公众用药安全有效。为充分发挥典型案例的警示震慑与教育引导作用，现将2025年第二批药品领域行政执法典型案例予以公布。一、王某某未经许可从事化妆品生产活动等案2025年3月，上饶市市场监管局接到国家12315平台举报线索，反映余干县黄金埠工业园区某公司租赁的厂房存在无证生产化妆品的违法行为。接到举报线索后，执法人员立即赶赴现场开展实地摸排。经初步核查，涉事区域共有七栋厂房，每栋厂房均在开展生产活动，且人员、车辆往来频繁，给目标厂房精准锁定带来一定难度。为精准确定目标厂房，执法人员用无人机航拍监控园区厂房生产规律，对厂房外原料废弃桶、生产垃圾及清运车辆全程跟踪，通过对原料废弃桶标签及内容物的分析最终确定目标厂房。因涉案厂房窗帘紧闭，无人机无法获取内部生产情况，执法人员转而跟踪园区货运车辆，重点核查原料进场、成品出库及关联物流站点流向，逐步核实举报事项属实。经查，当事人王某某在未取得化妆品生产许可证的情况下，擅自组织化妆品生产，所有涉案化妆品均无中文标签。经向商标持有人发函鉴定，王某某生产的某品牌化妆品均为假冒商品。当事人未经许可从事化妆品生产等行为，违反了《化妆品监督管理条例》第二十七条等规定。上饶市市场监管局依据《化妆品监督管理条例》第五十九条等规定，依法对当事人作出没收涉案化妆品并处罚款的行政处罚。二、许某经营未经注册的特殊化妆品案2025年5月，抚州市市场监管局接到国家化妆品网络经营监测平台移送线索，执法人员依法对南城县某小区开展现场检查。在当事人许某仓库内发现“柔迪祛斑王”等16款未经注册的特殊化妆品，共计3199瓶（盒）。当事人不能提供上述化妆品的注册证资料、检验合格证明和进货查验记录等证明材料。上述化妆品经检验汞含量等指标严重超标。经查，许某使用他人身份证在网络平台开设店铺销售未经注册的不合格化妆品且货值金额巨大。许某经营未经注册的特殊化妆品行为违反了《化妆品监督管理条例》第四条、第三十八条的规定并涉嫌犯罪。抚州市市场监管局依据《化妆品监督管理条例》第五十九条以及《行政执法机关移送涉嫌犯罪案件的规定》等规定，将案件依法移送至公安机关追究当事人刑事责任。三、景德镇某药房未按规定记录药品购进、未正确说明用法用量等事项案2025年5月，景德镇市市场监管局接市公安局禁毒支队举报线索通报，反映多名未成年人在宾馆服用愈美片后，尿检呈阳性。上述药品均在景德镇某药房购买，因愈美片含有右美沙芬成分但作为复方制剂未被列管，本案涉及未成年人健康安全，执法人员立即启动案件核查。经查，当事人自2024年6月25日起购进并销售愈美片，截至2025年6月7日，累计采购愈美片3930盒，期间退货215盒，实际销售3509.5盒。当事人仅能提供采购药品的随货同行单和手机端“药师帮”采购记录，无法提供完整药品验收记录和销售明细。涉事愈美片为乙类非处方药（OTC），每片含氢溴酸右美沙芬15毫克，属于右美沙芬复方制剂。根据《国家药监局 国家卫生健康委关于加强右美沙芬等药品管理的通知》，自2024年7月1日起，右美沙芬（包括其盐类、单方制剂）已列入第二类精神药品目录实施特殊管控，本案涉事愈美片虽为复方制剂未纳入该管控范围，但仍需按乙类非处方药经营规范执行销售管理。在销售过程中，当事人将愈美片包装拆开，按每板裸包装形式销售给前来购买的个人，明知前来购买的个人购买愈美片并非用于治疗用途，销售过程中既未向购买人提供产品包装盒、说明书，又未按要求告知购买人正确说明用法、用量。当事人购销愈美片未按照规定进行记录，未正确说明用法、用量等事项的行为涉嫌违反《中华人民共和国药品管理法》第五十七条、第五十八条的规定。景德镇市市场监管局依据《中华人民共和国药品管理法》第一百三十条的规定，作出吊销当事人药品经营许可证的行政处罚。四、张某某销售假药案2025年6月，瑞昌市市场监管局联合瑞昌市公安局执法人员根据有关线索对张某某通过微信向他人销售“古方强肾填精丸”和“参茸合方”的行为进行检查。在张某某家中现场查获“古方强肾填精丸”多瓶，“茸参合方”药丸若干，以及标签、说明书多份，执法人员依法对上述物品予以扣押。涉案物品经检验，均检出他达拉非化学药成分，涉案产品经九江市市场监管局认定为假药。经初步查明，张某某所售假药均从省外李某某处购进。2021年至2025年期间，张某某共购进涉案假药32万余元，并宣称产品为纯中药制剂，具有补肾助阳等功效，通过微信对外销售。当事人销售假药的行为违反了《中华人民共和国药品管理法》第九十八条的规定，因该案涉案金额大、情节严重，瑞昌市市场监管局依据《中华人民共和国药品管理法》第一百一十三条、《中华人民共和国行政处罚法》第二十七条以及《行政执法机关移送涉嫌犯罪案件的规定》的规定，依法移送至公安机关追究当事人刑事责任。五、鹰潭市某药店提供虚假材料骗取药品经营许可案2025年6月，鹰潭市市场监管局接到市医保局线索通报函，反映鹰潭市某药店存在执业药师“挂靠”问题。接通报线索后，执法人员立即对涉事药店进行检查。执法人员现场查阅了执业药师王某某的社保参保记录，发现参保单位为上饶市余干县某中心卫生院，与其实际执业单位不一致，确实存在执业药师“挂靠”问题。经查，王某某2019年入职余干县某中心卫生院，为该中心卫生院在职护士，至今一直从事护理工作，从未到涉事药店工作过。药店法人为达到药品经营许可申办要求，提供虚假材料骗取药品经营许可证。当事人提供虚假材料骗取药品经营许可证的行为违反了《中华人民共和国药品管理法》第五十二条、《药品经营和使用质量监督管理办法》第十一条的规定，鹰潭市市场监管局依据《中华人民共和国药品管理法》第一百二十三条的规定撤销其《药品经营许可证》，十年内不受理该药店办理《药品经营许可证》的申请，并处罚款。六、新余某大药房非法渠道购进药品、销售医保回流药案2025年7月，新余市市场监管局接投诉举报，反映新余某大药房涉嫌销售医保回流药。接到举报线索后，执法人员立即赶赴现场进行核查。经查，当事人在京东平台开设“某大药房官方旗舰店”，已办理《营业执照》《药品经营许可证》。执法人员对当事人经营场所存放的多款药品，通过“码上放心”APP扫描药品追溯码，发现上述药品来源涉及福建、北京等地医疗机构，当事人无法提供涉案药品的供货企业资质证明材料、购进清单及发票，亦不能说明药品合法来源，执法人员当场对涉案药品实施扣押。经确认当事人线下实体店未实际开展经营活动，所有药品销售业务均通过京东平台网店进行，当事人经营期间共销售药品43种，有效交易订单1023笔，涉案货值金额56万余元。当事人非法渠道购进药品、销售回流药的行为，违反了《中华人民共和国药品管理法》第五十五条的规定，因该案涉案金额大，情节严重，新余市市场监管局依据《中华人民共和国药品管理法》第一百一十三条、《中华人民共和国行政处罚法》第二十七条以及《行政执法机关移送涉嫌犯罪案件的规定》的规定，依法移送至公安机关追究当事人刑事责任。

按照《山东省药品经营企业长期停业和恢复经营监督管理规定》（鲁药监规〔2023〕8号），山东润青智慧医药物流有限公司等2家药品经营企业在《药品经营许可证》有效期内申请停业。停业期间，企业承诺不开展药品经营活动。企业在《药品经营许可证》有效期内恢复药品经营，需向药监部门提交书面报告，并经检查符合要求后方可恢复经营活动。现予以公告。长期停业药品经营企业（单位）名单序号企业名称药品经营许可证号许可证有效期至注册地址停业截止时间备注1山东润青智慧医药物流有限公司鲁AA531006252028年12月10日山东省济南市市中区二环南路11111号一号办公楼一层、三层2026年4月9日2青岛亿博医药有限公司鲁AA5320005002028年7月26日山东省青岛市李沧区重庆中路877号甲南区三层312室2026年4月26日山东省药品监督管理局 2025年11月5日

Delivery Method:Via EmailProduct:DrugsRecipient:Danielle WhitePresidentIBSPOT.com Inc.1414 Willow AvenueElkins Park,PA19027United Statessupport@ibspot.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTEROctober 27, 2025RE: 715657Dear Danielle White:This letter concerns your firm’s distribution of “Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches” products that violate the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”). As discussed further below, your firm is responsible for introducing or delivering for introduction into interstate commerce these products, which are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Furthermore, these products are misbranded drugs under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). As explained further below, introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(a), 301(d), and 505(a) of the FD&C Act, 21 U.S.C. 331(a), 331(d), and 355(a).FDA purchased “Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches” products through your website, www.ibspot.com. These products were introduced or delivered for introduction into interstate commerce by IBSPOT.com.1FDA confirmed through laboratory analyses that “Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches” purchased on www.ibspot.com contained the ingredients diphenhydramine, diphenhydramine N-oxide, and diclofenac, which are not listed on the product labels.Unapproved New Drugs“Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches” are drugs as defined by section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Examples from your product labeling that provide evidence of the intended use (as defined in 21 CFR 201.128) of the products as drugs include, but may not be limited to, the following:Taoscare Motion Sickness PatchImages of a plane, boat/ship, train, and bus“Motion Sickness Patch”“Fast Acting”“Anti-Nausea Fast”“Non-Drowsy”“72h LONG EFFECT”“The patch can be used behind the ears and on the navel at the same time if motion sickness is serious.”Navabelle Motion Sickness PatchesImages of a plane, boat/ship, train, and car“MOTION SICKNESS PATCHES”“Anti-Nause Fast” [sic]“Non-Drwsy” [sic]“INDICATIONS:Relieve the vomiting, nausea, dizziness, anorexia, and other sickness symptoms caused by taking cars, ships, planes, trains, and other means of transport.”“Anti-Nausea Relief Patches”“Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the above-described conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs and the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Misbranded DrugsIn addition, “Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches” are misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The respective labeling for “Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches” does not declare that the products contain the ingredients diphenhydramine, diphenhydramine N-oxide, or diclofenac. With the omission of these ingredients on the label, consumers may not be able to determine whether the products are appropriate for them to use due to, for example, potential drug allergies or interactions. The failure to disclose these ingredients in the products’ labeling renders “Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches” misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).The introduction or delivery for introduction into interstate commerce of these misbranded drugs is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to regulatory or legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “715657” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug Administration______________________________1IBSPOT.com distributed each of the products to individual U.S. consumers. Each of the products discussed in the warning letter was “fulfilled” by IBSPOT; your product listings for each of these products stated, “Fulfilled by IBSPOT.”

Delivery Method:Via EmailReference #:320-26-01Product:Drugs、Over-the-Counter DrugsRecipient:Mr. Yuegen WangGeneral ManagerTaizhou Kangping Medical Science and Technology Co., Ltd.Building 3, No 27 Tai’an RoadHailing Industrial ParkHailing QuTaizhou ShiJiangsu Sheng,225300ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-01October 9, 2025Dear Mr. Wang:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Taizhou Kangping Medical Science and Technology Co., Ltd., FEI 3013321339, at Building 3, No 27 Tai’an Road, Hailing Industrial Park, Taizhou City, Jiangsu, China 225300, from March 10 to March 14, 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 reviewed your April 4, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Your response is inadequate because you failed to take corrective actions to bring your operations into compliance with CGMP.During our inspection, our investigator observed specific violations including, but not limited to, the following:1. Failure to establish procedures designed to prevent micro-contamination in products purporting to be sterile (21 CFR 211.113(b)).Your(b)(4)are labeled as “Sterile unless(b)(4).” However, your(b)(4)are not sterilized, which you confirmed in your response on May 10, 2025: “…(b)(4)… isNonsterile product....” Sterile(b)(4)may be used by healthcare practitioners as a(b)(4). Sterile(b)(4), if labeled as sterile, must have controls in place to ensure sterility. The inspection documented that you do not perform sterility testing of the drug product, and that the Specification and Analysis Method on(b)(4)tests the Finished Product Quality Standards to Microbial Limits USP method, with acceptance criteria of ≤(b)(4)cfu/gram of total aerobic bacteria and ≤(b)(4)cfu/gram of mold, yeast.Drugs purported to be sterile must comply with applicable 21 CFR 211 CGMP requirements (including sterility assurance).On July 16, 2025, FDA held a teleconference with you and your U.S. agent. We acknowledge your decision to initiate a recall of all your(b)(4)within expiry currently in distribution to the U.S. market.2. Failure to establish appropriate product specifications and scientifically sound testing procedures (21 CFR 211.160(b)).A. Your high-performance liquid chromatography (HPLC) analyses for(b)(4)Assay Content lacked an appropriate determination of system suitability, as outlined in USP , before sample injections. Your quality approved test method, Quality Specification and Operating Procedures for Testing(b)(4), is not scientifically sound in that your Quality Control (QC) analysts are instructed to generate a chromatographic standard curve “(b)(4).” This method of calculation from the standard curve has the practical effect of masking system drift and performance issues that affect the quantitative accuracy of batch-specific test results, because the frequency is conducted “(b)(4).”In your response, you commit to revising the frequency of establishing a standard curve (linear solution test) from “(b)(4)” to “at the same time with each sample test.” However, your response is inadequate because you have not committed to ensuring that standard curves (linear solution tests) performed “at the same time with each sample test” are extended to include gas chromatography (GC), which is used to determine(b)(4)Assay Content.B. Your firm lacked sufficient controls over GC and HPLC data acquisition systems that are used to test assay label claims for drug products before release. Specifically, Excel worksheets used to perform chromatogram calculations were not retained, and access accounts to the GC and HPLC workstations were shared by job title and were not attributable to the individual analyst. The inspection documented the deletion of several recent Excel spreadsheets that were used to perform suitability and assay calculations. Your QC Supervisor/Manager confirmed that the Excel spreadsheets that were relied upon to generate the finished product quality standards, had not been validated, controlled, retained, or quality verified for data integrity before they were used for product release. Further, this individual was the only analyst who performed testing, yet maintained administrative privileges within the system. When further questioned on this practice, the QC Supervisor/Manager identified that the administrative role was the only primary access point to the Gas Chromatography data acquisition software for OTC(b)(4)product release and stability testing.Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance documentData Integrity and Compliance With Drug CGMPfor guidance on establishing and following CGMP-compliant data integrity practices, at https://www.fda.gov/media/119267/download.We acknowledge that you are using an independent third-party consultant to audit your operation and assist in meeting FDA requirements. In response to this letter, provide:A comprehensive investigation into the extent of the inaccuracies in data records and reporting, including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity, and analyses of the risks posed by ongoing operations.A management strategy for your firm that includes the details of your global corrective action and preventive action plan (CAPA). The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm, including microbiological and analytical data, manufacturing records, and all data submitted to FDA.Product SpecificationsUpon further review of the records and information you provided, process controls for the(b)(4)appear to be inconsistent with the applicable conditions for an OTC(b)(4)formulated with(b)(4)as an active ingredient. For OTC(b)(4)drug products marketed under 505G of the FD&C Act, such as the(b)(4), the allowable concentration for the active ingredient(b)(4)is(b)(4)%-(b)(4)%. However, throughout the product lifecycle for the(b)(4), your operations seem to far exceed the allowable concentration of(b)(4)as indicated in your process validation. For example, your Specification and Analysis Method allows for the release of products with concentrations of(b)(4)up to(b)(4)%. In addition, your 2024 Annual Quality Review and 2023 Process Validation summary of Critical Quality Attributes reports also include concentrations of(b)(4)that are well above what is allowed with values detected at(b)(4)-(b)(4)%. Although your(b)(4)are labeled with(b)(4)at a concentration of(b)(4)%, as noted, your operations and process controls appear to deviate from the proposed conditions and requirements for an OTC(b)(4)product. For consistent regulatory compliance it is essential that OTC(b)(4)products like your(b)(4)conform to the applicable FDA requirements and OTC monograph conditions for the lawful distribution of this OTC drug product without an approved application.Drug Production CeasedYour written responses to date commit to cease the commercial distribution of OTC products in the U.S. market starting March 14, 2025. If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure that your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPA.Drug RecallOn July 16, 2025, FDA held a teleconference with you and your U.S. agent, during which you committed to the recall of all your(b)(4)within expiry currently in distribution to the U.S. market.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 September 18, 2025.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’s continuing to refuse admission of articles manufactured at Taizhou Kangping Medical Science and Technology Co., Ltd., located at Building 3, No 27 Tai’an Road, Hailing Industrial Park, Taizhou City, Jiangsu, China 225300, 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 or misbranded 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), and are misbranded under section 502 of the FD&C Act, respectively.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 3013321339 and ATTN: Kara S. Quinn.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research/S/Tina SmithCaptain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and Research

为进一步做好智能监管改革试点工作，帮助定点医药机构及其工作人员熟悉掌握医保基金监管规则，通过智能化方式主动合规、持续合规，实现监管关口前移，近日，我们结合国家医保局公布的前六批智能监管“两库”规则和知识点完成了《河南省第一批智能审核明确规则》的意见征求和修订完善工作，包括第一批智能监管明确违规规则药品清单（见附件1）和第一批智能监管明确违规规则医疗服务项目清单（见附件2），现面向社会公开。定点医药机构可以将智能监管“两库”置于本机构智能提醒等信息化系统中，也可以对接医保部门智能监管系统事前提醒功能模块，对医保基金使用行为开展自动提醒和自查自纠。联系人：袁伟联系电话：0371-696980722025年11月11日

各相关单位：经公示，现公布山东招采管理子系统部分挂网（备选）目录产品调整结果。2025年11月11日

河北港通物流有限公司：你公司《关于药品现代物流企业资质申请》收悉。按照我省药品现代物流企业资质有关规定，经审查，你公司符合药品现代物流企业标准，现批复如下：药品现代物流企业资质信息为：河北港通物流有限公司；社会信用代码：91130100MA07M9YC2H；《药品经营许可证》证号：冀AA311J00168；药品现代物流仓库地址：中国（河北）自由贸易试验区正定片区石家庄综合保税区风洲路5号。药品现代物流资质效期至2029年12月31日。河北省药品监督管理局2025年11月11日

近日，内蒙古自治区药监局首次推出药店现场检查真人实景带教VR教学课程，旨在进一步提升药店现场检查培训效能，持续强化药品监管人员的现场检查实战能力。课程首次引入真人专家实景带教，邀请自治区药品检查中心国家级药品生产检查员、北疆药监培训内培师资孙睿带教。在VR重现的药店场景中，孙睿完整、系统讲解了药店现场检查全流程关键环节、核心要点及常见风险，为学员提供精准、专业的实践指导。同时，课程依托720°全景VR拍摄技术，涵盖17个动态场景、17个静态场景、51个交互热点及3类错误提示功能，为学员提供了仿真、交互、沉浸式的学习体验。“专家实景带教”与720°全景VR融合的双轨教学模式，成功打破了时间与空间的培训壁垒，让学员足不出户即可身临其境进行实战训练，为提升药品监管队伍专业能力、破解基层培训资源不均难题，搭建起高效便捷的新路径。欢迎大家扫描下方二维码观看学习

安徽省药品生产监督检查信息通告（2025年10月）序号检查企业名称检查类型检查时间检查综合评定结论处理措施备注1安徽张恒春药业股份有限公司常规检查2025年2月25－27日符合要求2安徽安科恒益药业有限公司常规检查2025年3月12－15日符合要求3芜湖绿叶制药有限公司常规检查2025年3月13－14日符合要求4华佗国药股份有限公司常规检查2025年5月27－30日符合要求5安庆市中医医院制剂室常规检查2025年6月5日符合要求 6安徽威尔曼制药有限公司其他检查2025年7月2－6日符合要求7亳州亚英医药科技有限公司常规检查2025年7月8—9日符合要求8合肥英太制药有限公司其他检查2025年7月17－19日符合要求9宣城市众诚医药有限公司常规检查2025年8月5－8日符合要求10安徽国正药业股份有限公司常规检查2025年9月10日符合要求11阜阳市中医医院常规检查2025年9月10-11日不符合要求暂停医疗机构制剂配制，暂停硝英洗剂使用 12中盐安徽红四方股份有限公司其他检查2025年9月19日符合要求13安徽悦康凯悦制药有限公司常规检查2025年9月25日符合要求14濉溪县中医医院常规检查2025年9月23－24日符合要求15安徽肽渡生物医药科技有限公司其他检查2025年9月30日符合要求16合肥亿帆生物制药有限公司其他检查2025年10月13日符合要求17安徽恒星制药有限公司其他检查2025年10月14日符合要求 18新宇药业股份有限公司常规检查2025年10月15－16日符合要求19安徽贤桂医药科技有限公司常规检查2025年10月20－23日符合要求20福元药业有限公司常规检查2025年10月22－23日符合要求21池州东升药业有限公司常规检查2025年10月26－28日符合要求22安徽海康药业股份有限公司常规检查2025年10月30－31日符合要求