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上海市人民政府办公厅关于印发《上海市全面深化药品医疗器械监管改革促进医药产业高质量发展的若干措施》的通知

Notice from the General Office of the Shanghai Municipal People’s Government on the Issuance of the ‘Several Measures for Comprehensively Deepening the Reform of Drug and Medical Device Regulation and Promoting High-Quality Development of the Pharmaceutical Industry in Shanghai’
No document number
Radar: Medical devices (rank 13 of 16) · Pharmaceuticals (rank 4 of 16)

Country-interest evidence · pilot

Trade inferences use UN Comtrade, with China as reporter. Country connections indicate potential trade relevance, not measured harm, firm-level exposure or legal applicability. Inward measures concern exporters to China; competition with Chinese exports in third markets is not assessed.

Inspect implementing jurisdictions and partner evidence · 58 relationships

Argentina: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 66,684,030

Australia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 465,203,411

Austria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 1,049,442,228

Belgium: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 1,008,053,820

Bulgaria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 13,521,465

Brazil: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 29,845,114

Barbados: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 10,580,559

Canada: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 416,712,712

Switzerland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 4,175,382,297

Costa Rica: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 668,651,979

Cuba: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 1,462,576

Cyprus: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 2,593,380

Czech Republic: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 102,707,941

Germany: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 9,279,650,388

Denmark: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 1,494,905,860

Dominican Republic: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 157,321,755

Spain: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 832,668,240

Estonia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 1,560,577

Finland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 249,935,216

France: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 3,552,469,444

United Kingdom: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 1,219,504,027

Greece: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 295,300,974

Hong Kong, China: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 631,840,398

Croatia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 2,826,627

Hungary: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 66,709,983

Indonesia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 11,159,674

India: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 283,051,470

Ireland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 8,060,099,449

Iceland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 4,080,396

Israel: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 396,272,614

Italy: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 3,302,469,959

Japan: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 3,459,712,828

Korea, Rep.: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 708,262,492

Lithuania: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 5,195,062

Macao: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 1,143,254

Mexico: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 2,300,981,262

Malaysia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 281,474,350

Netherlands: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 1,185,013,578

Norway: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 45,363,126

New Zealand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 79,354,766

Pakistan: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 12,186,846

Philippines: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 11,384,205

Poland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 93,439,837

Portugal: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 7,698,631

Romania: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 27,596,636

Russian Federation: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 3,924,462

Singapore: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 460,275,507

Slovak Republic: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 3,253,586

Slovenia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 29,808,299

Sweden: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 1,838,998,777

Thailand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 126,234,101

Turkey: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 64,964,687

Chinese Taipei: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 306,753,452

Uruguay: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 15,123,065

United States: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 10,811,270,543

Vietnam: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 405,910,146

South Africa: Trade-based inference; exporters to China; summed product trade > USD 1m; 2024 trade; broad sector headings; computed, not analyst-reviewed · intervention 59867 · recorded trade USD 19,134,791

Implementing jurisdiction: China · intervention 59867

Assessment states
  • Trade-based partners recorded

Measures

Local production condition
Provincial · origin: Chinese firms or production in China · locality: Local firms · CPC 352; 481 · Keyword screen (unreviewed)
Implemented by China (subnational) · affects 57 partners (inferred from trade data, 2024 trade): United States, Germany, Ireland, Switzerland, France, Japan …
对在研重点药品、进口转本地生产药品优先进行注册抽样和检查，同步开展注册核查与生产质量管理规范符合性检查。

Asymmetric provisions

Local production requirement (本地生产)
Disadvantages: imports firms from other regions · Keyword screen (unreviewed)
对在研重点药品、进口转本地生产药品优先进行注册抽样和检查，同步开展注册核查与生产质量管理规范符合性检查。
Local production requirement (本地生产)
Disadvantages: imports firms from other regions · Keyword screen (unreviewed)
对已上市的进口和外省市转入我市生产的第二类医疗器械，优化注册资料申报要求和生产现场核查程序，鼓励批量转产，实施集中审评、合并或减免现场核查；

Same central policy, other provinces

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Hubei 省药品监督管理局关于印发 《关于支持医疗器械产业高质量发展服务支点建设的若干措施》的通知 2026-02-28 425 d
Beijing 北京市商务局关于印发《推进医药健康产业发展促进药械产品进口工作方案》的通知 2026-05-11 497 d
Held documents only: these are counts of what we have collected, not of what each province issued.

Full text

各区人民政府，市政府有关委、办、局，各有关单位： 经市政府同意，现将《上海市全面深化药品医疗器械监管改革促进医药产业高质量发展的若干措施》印发给你们，请认真按照执行。 上海市人民政府办公厅 2025年10月23日 上海市全面深化药品医疗器械监管改革促进医药产业高质量发展的若干措施 为深入贯彻落实国务院办公厅《关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意见》，加快促进我市医药产业高质量发展，制定如下措施。 一、支持研发创新 （一）打造协同创新生态。深化药品医疗器械监管改革，进一步完善监管体系、监管机制、监管方式，健全审评审批机制，优化服务方式和程序，提升审评审批质量效率，强化监管促加速；深化医疗、医保、医药协同，大力支持研发创新，探索医疗、医保数据资源利用和开放共享，加速创新药品医疗器械转化上市和临床应用，更好服务医药创新和产业高质量发展，加快建设具有全球影响力的生物医药产业创新高地。（责任单位：市药品监管局、市卫生健康委、市科委、市经济信息化委、市医保局） （二）提升服务能级。聚焦细胞与基因治疗、罕见病、儿童用药、高质量首仿药、人工智能医疗器械、医用机器人、脑机接口、粒子治疗设备、创新中医诊疗设备等重点领域和产品，建立在研重点品种服务清单，在临床试验、注册上市、检查检验、生产许可等环节跨前指导。夯实国家、市、区三级联动服务机制，支持国家药监局药品审评检查长三角分中心、医疗器械技术审评检查长三角分中心能力提升，加快区生物医药产品注册指导服务工作站扩能升级，开展在研创新产品信息收集、重点项目跨前指导和跟踪服务。完善医疗卫生机构伦理协作审查机制，简化统一受理资料和流程、增加会议频次、缩短审查时间，推进长三角区域多中心临床试验伦理协作审查。加强临床医疗数据标准化，强化数据在研发创新中的运用。建立以临床价值为导向的创新医疗器械筛选评估机制，加速转化上市。（责任单位：市药品监管局、市卫生健康委、市科委、市经济信息化委、申康医院发展中心） （三）支持中药研发创新。建立医疗机构规范收集整理人用经验数据机制，探索人用经验数据作为真实世界证据用于药品注册申报。制订医疗机构应用传统工艺配制中药制剂备案管理规定。支持疗效确切、特色优势明显的医疗机构中药制剂及名老中医方开发转化为中药新药。鼓励医疗机构、研发单位和药品企业共同打造中药创新与产业转化平台，支持中药创新药临床研究和古代经典名方中药复方制剂研究，鼓励中药大品种培育和经典品种二次开发。外省市按照国家药品标准生产的中药配方颗粒在我市销售的，免予备案。（责任单位：市药品监管局、市科委、市卫生健康委、市中医药管理局） （四）强化标准引领。积极参与药品医疗器械国家标准制修订和国际标准协调。发挥新型标准化技术组织作用，推进人工智能医疗器械、医用机器人、脑机接口、粒子治疗设备、创新中医诊疗设备、细胞与基因治疗等前沿技术的标准化研究。持续开展中药饮片、中药配方颗粒及中医医疗器械标准研究，依托国际标准化组织/中医药技术委员会（ISO/TC249）等国际标准化平台，制定中医药国际标准。支持药品医疗器械生产过程数字化追溯等团体标准制订。（责任单位：市药品监管局、市市场监管局、市科委、市中医药管理局、市经济信息化委） （五）加强知识产权保护。健全创新药品医疗器械专利快速审查服务机制，加大专利侵权纠纷行政裁决工作力度，对拥有自主专利的创新药品医疗器械，实施严格知识产权保护。开展药品医疗器械领域专利导航。鼓励高校、科研机构、医疗机构等创新主体开展高价值专利培育，提升专利质量和转化运用效益。探索细胞与基因治疗专利专题数据库建设。（责任单位：市知识产权局、市卫生健康委） （六）加快创新产品应用。持续优化完善我市新上市药品挂网服务，积极申请成为新上市药品首发挂网省份。推动扩大医疗服务项目和医用耗材医保支付范围，覆盖更多创新产品。对企业创新产品收费编码申请予以提前指导和资料预审。在国家医保药品和“新优药械”产品目录发布1个月内，根据临床需求和医院特色，及时配备使用。探索“新优药械”从研发到使用的高效对接机制，优化临床急危重症抢救不可替代新药的入院流程，逐步实现由30个工作日缩减至15个工作日。对符合规定的“新优药械”产品，及时研究纳入医保支付范围，鼓励商业健康险产品覆盖更多“新优药械”。在试点医疗机构探索开展医保和商业保险同步结算，打通更多支付路径。制订临床急需药械临时进口服务指导方案。探索特定医疗机构先行进口未在境内注册上市的临床急需罕见病用药械。（责任单位：市科委、市卫生健康委、市医保局、市药品监管局、申康医院发展中心） 二、深化落实国家改革试点任务 （七）推动药品领域改革。支持符合条件的创新药临床试验审评审批时限缩短至30个工作日，并积极推广试点经验。依托药物临床试验大数据监管平台，提升临床试验质效。开展化学药品等补充申请审评审批程序改革，对我市药品重大变更申报前的注册核查和检验提供前置服务，实现需核查检验的化学药品补充申请审批时限缩短至60个工作日。争取境外生产药品补充申请审评审批和仿制药立卷审查试点，加快首仿品种上市。完善已上市药品变更流程及指南，对符合要求的场地变更合并开展许可检查、注册核查及药品生产质量管理规范符合性检查。遴选符合条件的品种开展生物制品分段生产试点，推进重大外资项目跨境分段生产试点，并提供通关便利。探索开展药品连续制造试点。（责任单位：市药品监管局、上海海关） （八）推进医疗器械领域改革。鼓励医疗机构加快开展自行研制使用体外诊断试剂试点工作。推进已备案医疗机构自行研制使用体外诊断试剂的临床使用数据，应用于产品注册申报。支持医疗器械产业聚集度高的园区建设符合要求的检验检测、工艺用水用气等设施设备，供园区内医疗器械生产企业共享共用。（责任单位：市药品监管局、市卫生健康委、上海海关） 三、提升审评审批质效 （九）健全审评审批机制。加强在研重点品种注册申报前置指导，属于省级审评审批事项的，实施预查预检、即到即审、智慧审评，完善审评指南。对在研重点药品、进口转本地生产药品优先进行注册抽样和检查，同步开展注册核查与生产质量管理规范符合性检查。对在研重点医疗器械提供注册体系核查预审服务，优先注册检验，实施研检联动。新开办医疗器械生产企业已在同一生产地址通过产品注册体系现场核查且不存在真实性问题或严重缺陷的，可减免生产许可现场检查。（责任单位：市药品监管局） （十）提升第二类医疗器械注册审评效能。对具有明显临床价值、创新性强的第二类医疗器械，鼓励申请适用创新特别审查程序，优先注册检验、技术审评和注册体系核查；属于全国首个或符合优先审批条件的医疗器械参照实施。完善咨询路径，优化注册申报事前辅导和事中服务机制，提高申报资料质量、缩短补正时间，第二类医疗器械首次注册平均周期压缩至六个月内。立卷审查中提出的第二类医疗器械分类界定在两周内完成。对符合条件的第二类医疗器械变更注册和延续注册实施联合办理，探索优化注册收费机制。对已上市的进口和外省市转入我市生产的第二类医疗器械，优化注册资料申报要求和生产现场核查程序，鼓励批量转产，实施集中审评、合并或减免现场核查；符合要求的，5个工作日内完成技术审评。（责任单位：市药品监管局、市发展改革委、市财政局） （十一）优化注册检验。加快生物制品批签发检验和进口药品通关检验速度，确保进口药品到港后3个工作日内实施抽样，每批次用量从全项检验用量的3倍减为2倍。探索优化罕见病药品进口抽检模式，除留样备查外，允许检验合格且未发生损耗的剩余药品上市销售。畅通创新药和医疗器械检验绿色通道，实行临床急需药品医疗器械即收即检。（责任单位：市药品监管局） （十二）提升检验能级。加强生物制品、脑机接口、植入式医疗器械、大型医疗设备和医疗软件等专业技术服务平台建设，为企业提供产品安全评价、质量控制、注册备案、风险评估、注册检验等服务。推进生物制品（疫苗）批签发能力建设，配备相适应的人员、仪器设备和设施场地，扩大授权的品种范围。季节性流感疫苗的批签发时限缩短至30个工作日。（责任单位：市药品监管局） 四、扩大高水平开放合作 （十三）推进长三角监管协同。完善产业服务、风险排查、标准引领、执法协同等领域合作。加强药品医疗器械委托生产、分段生产的跨区域监管合作，推进长三角地区药品上市后变更管理工作程序及相关标准统一，推动实现区域注册备案审评要求和检查标准统一、结果互认。（责任单位：市药品监管局） （十四）对接国际规则助力出海。发挥世界卫生组织预认证实验室优势，支持检验检测机构获得国际权威技术组织认可，积极引进国际权威检测认证机构，为国产药品医疗器械出海提供全球认可的检验服务。完善我市药品监管质量管理体系，配合国家药监局做好申请加入国际药品检查合作计划（PIC/S）相关工作。支持创新药械在沪开展国际多中心临床试验。搭建平台，鼓励企业开展国际注册申报。培育国际化医药合同研发生产企业（CDMO），鼓励面向国际市场承接研发生产服务。拓宽医疗器械出口销售证明的出具范围。支持符合条件的医疗器械企业在综合保税区内按照相关规定开展保税维修业务。（责任单位：市药品监管局、市科委、市经济信息化委、市卫生健康委、市市场监管局、市商务委、申康医院发展中心、上海海关） 五、构建全生命周期监管 （十五）强化医药流通新业态监管。完善药品现代化物流条件，鼓励药品批发企业整合仓储和运输资源，构建跨区域多仓协同管理模式；支持药品生产企业共享药品现代物流企业仓储资源，支持医疗器械运输贮存服务企业按照规定跨省设置仓库，推动药械流通行业集约化、规模化发展。药品零售企业被其他药品零售连锁总部收购的，可按照变更程序简化办理经营许可。加强药品和医疗器械网络交易平台监管，探索第三方监测，督促平台健全质量管理体系。（责任单位：市药品监管局、市商务委、市市场监管局） （十六）加强高风险产品监管。强化创新、附条件上市产品的监测和风险会商，建立创新药械上市后风险排查清单，对关键指标实施评价性抽检，开展上市后安全性评价。强化在产疫苗生产企业派驻监管。探索将真实世界数据研究成果转化运用至监管。（责任单位：市药品监管局） （十七）推进医药产业数智化转型。推动人工智能技术与医药全产业链融合，加快人工智能药物发现与设计系统应用，推动医药大模型赋能研发。鼓励生产企业数智化转型，应用智能制药、实验室管理、制造执行等智能化系统，加快建设数智化、规模化、品牌化企业。鼓励我市疫苗生产企业建设和改造生产线，严格落实生产检验过程信息化，血液制品企业建立覆盖采浆、入厂、生产、检验全过程的信息化体系，实现全程追溯。鼓励医药流通企业构建供应链数智化协同平台，推广智能仓储调度，促进供应链间数据电子化和应用共享。（责任单位：市经济信息化委、市科委、市商务委、市药品监管局） （十八）推进协同治理。对国家集采中选产品实行生产企业检查和中选品种抽检全覆盖，强化中选药品不良反应和医疗器械不良事件监测。督促集采品种持有人加强产品质量控制，规范原辅料变更管理。推进仿制药质量和疗效一致性评价，并向其他剂型拓展。协同建立集采药品疗效反馈收集机制。（责任单位：市药品监管局、市卫生健康委、市医保局） 六、强化监管能力建设 （十九）加强职业化专业化能力建设。强化监管技术支撑机构建设，承接国家改革试点任务。加强检查员队伍建设和能力提升，科学划分检查员类别，优化各类检查员管理。支持产业集聚区有序开展重点产业技术服务，稳步提升与区域产业特点相适应的审评检查能力。（责任单位：市药品监管局、市人力资源社会保障局） （二十）推进监管科学研究。推进国家药监局监管科学创新研究基地建设。将药品监管科学研究纳入我市科学技术体系，加强我市药品医疗器械科技创新基地建设。支持高等院校、科研机构、医疗机构、企事业单位参与药品监管科学研究，启动监管科学重点项目，推出监管新工具、新标准、新方法。鼓励高等院校设立药品监管科学专业，培养专业人才。建立政企交流机制，开展联合咨询、精准服务，推进药品医疗器械新技术、新业态落地。（责任单位：市药品监管局、市科委、市经济信息化委、市教委） （二十一）提升行政检查质效。加大涉企行政检查统筹力度。落实国家、市、区三级协同和跨层级联合检查制度，推进许可检查、注册体系核查与生产质量管理规范符合性检查、药物警戒检查等应并尽并、协同开展。实施跨区域跨部门监管协同。（责任单位：市药品监管局） （二十二）强化全生命周期数智监管。建设数字化监管平台，完善品种和信用档案，强化创新产业地图、AI+智慧辅助审评审批、AI+现场监管、风险预警等在监管中的应用。深化医疗器械唯一标识应用，加强与医疗、医保等衔接，逐步扩大品种范围。持续推动中药饮片全程追溯，推进中药代煎配送等服务数智化建设。（责任单位：市药品监管局、市卫生健康委、市医保局、市中医药管理局）