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外 Waitan Ludi Policy Terminal China industrial-policy monitor · updated 2026-11-10
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江苏省药品监督管理局印发关于深化“面对面”对接服务推动生物医药领域经济运行率先整体好转若干政策措施的通知

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Radar: 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 · 48 relationships

Australia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 158,485,263

Austria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 195,459,525

Belgium: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 33,553,894

Bulgaria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 9,352,651

Brazil: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 9,133,684

Barbados: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 25,717,430

Canada: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 73,310,309

Switzerland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 804,236,540

Costa Rica: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 485,339,666

Czech Republic: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 76,661,527

Germany: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 3,491,972,712

Denmark: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 111,367,306

Dominican Republic: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 94,740,759

Spain: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 24,855,015

Estonia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 1,424,506

Finland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 46,101,560

France: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 436,896,219

United Kingdom: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 374,951,193

Hungary: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 33,494,529

Indonesia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 4,191,333

India: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 125,986,538

Ireland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 892,313,189

Iceland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 4,381,178

Israel: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 440,683,376

Italy: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 184,432,818

Japan: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 1,797,311,154

Korea, Rep.: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 685,569,377

Mexico: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 2,175,471,103

Malaysia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 272,691,877

Netherlands: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 649,859,583

Norway: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 43,912,522

New Zealand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 42,923,719

Pakistan: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 11,796,804

Philippines: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 11,355,446

Poland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 52,542,599

Romania: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 10,240,005

Russian Federation: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 4,382,691

Singapore: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 342,153,137

Slovak Republic: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 2,582,418

Slovenia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 17,908,435

Sweden: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 84,206,056

Thailand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 120,176,442

Turkey: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 47,134,095

Chinese Taipei: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 144,600,446

Ukraine: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 2,104,194

United States: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 5,380,073,012

Vietnam: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 74997 · recorded trade USD 353,870,464

Implementing jurisdiction: China · intervention 74997

Assessment states
  • Trade-based partners recorded

Measures

Tax relief
Provincial · origin: Chinese firms or production in China · locality: Local firms · CPC 481 · Keyword screen (unreviewed)
Implemented by China (subnational) · affects 47 partners (inferred from trade data, 2022 trade): United States, Germany, Mexico, Japan, Ireland, Switzerland …
免征小微企业医疗器械产品首次注册费。
Supports production in a place, so favours that place by rule.

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各设区市市场监督管理局，省局各处室、检查分局、直属单位，省局审评核查各分中心： 经省局党组同意，现将《关于深化“面对面”对接服务推动生物医药领域经济运行率先整体好转的若干政策措施》印发你们，请认真贯彻落实。 江苏省药品监督管理局 2023年2月14日 关于深化“面对面”对接服务推动生物医药领域经济运行率先整体好转的若干政策措施 为深入贯彻党的二十大精神，全面落实省政府《关于推动经济运行率先整体好转的若干政策措施》（苏政规〔2023〕1号）相关部署，推动高效完成《省政府办公厅印发关于优化审评审批服务推动创新药械使用促进医药产业高质量发展行动方案（2022－2024年）的通知》（苏政办发〔2022〕1号）年度目标任务，按照“六减”工作要求，持续推进审评审批制度改革，深化“面对面”对接服务，优化药品监管领域营商环境，进一步提升企业的获得感和满意度，提振医药领域市场主体发展信心，促进生物医药领域经济运行率先整体好转，现提出如下政策措施。 一、全面落实现行政策工作目标 （一）持续减免药品领域涉企收费。免征小微企业医疗器械产品首次注册费。2023年底前，按现行标准的80%收取药品再注册费、医疗器械变更注册和延续注册费；对进入药品特别审批程序、用于治疗和预防新型冠状病毒感染的药品，进入医疗器械应急审批程序并与新型冠状病毒相关的防控产品，免征注册费；对一般医疗器械企业产品检验收费减免5%，对小微医疗器械企业产品检验收费减免10%。 （二）进一步压缩业务办理时限。第二类医疗器械延续注册审评、生产许可证延续办理时限分别缩减至30个、10个工作日。有源类、无源类医疗器械检验时限分别缩减至85个、60个工作日。药品注册检验时限缩减至45个工作日，需标准复核的时限缩减至70个工作日。 （三）加快推进技术分支机构建设。2023年6月底前，省药监局审评核查南京、南通、扬州分中心启动赋权；无锡、徐州、常州、苏州、连云港、泰州6个审评核查分中心启动二、三类事项赋权。2023年12月底前，省食品药品监督检验研究院无锡、苏州检验室和泰州检验室化学药品实验室建成运行；省医疗器械检验所徐州、南京高淳检验室建成运行；对符合条件的审评核查分中心完成第三类事项赋权。 二、持续优化监管服务举措 （四）支持防疫药械研发生产。建立“一企一专班”，开辟绿色通道，对用于治疗和预防新型冠状病毒感染的药品、医疗器械实施应急审批。对有扩能增产需求的防疫药械即到即审，开展研审联动、风险会商，加快产品上市。 （五）加大重点领域支持力度。建立健全重点园区重点企业重点产品服务保障制度，完善“一对一”服务机制，助推创新产品上市、企业做大做强、园区创新发展。对第三类高端医疗器械实施审评重心前移，推行注册受理前技术咨询。对转型快、技术优、有影响力的龙头企业，定期联系沟通指导、及时解决企业困难问题。发挥省药监局审评核查分中心、省食品药品监督检验研究院和省医疗器械检验所驻外检验室作用，鼓励支持园区设立创新服务站，培育注册申报服务专员队伍。对省级重大项目及涉药领域重点外资项目，明确具体联系人，全过程跟踪服务。 （六）全面优化审评审批流程。药品上市后生产场地变更审评不再要求提交《药品生产许可证》、GMP符合性检查、直接接触制剂的包装材料和容器等批准证明文件。依托省药品智慧监管综合平台，对医疗机构制剂注册免于提交《医疗机构执业许可证》《医疗机构制剂许可证》《医疗机构制剂临床试验批件》等批准证明文件。以有源医疗器械为试点，全面推行二类医疗器械首次注册立卷审查。探索药品经营批发零售一体化许可工作新模式。 （七）完善医药产业创新发展平台。充分发挥国家药监局医疗器械创新江苏服务站作用，为疫情防控、“卡脖子”技术、临床急需、治疗罕见病相关产品注册申报提供前置指导；重点关注医疗器械领域揭榜挂帅的人工智能和生物材料项目，助推关键核心技术攻关。建设省食品药品监督检验研究院药品创新发展技术服务平台，就产品设计、标准研究、质量控制等关键技术提供指导。组织开展我省国家药监局重点实验室进园区活动，搭建实验室与企业共享交流合作平台；举办“药师周”“苏药学堂”等品牌学术交流活动，为企业提供专业咨询服务。 （八）扩充检验检测服务资源。构建“一体多翼”检验服务新格局，加快推进省食品药品监督检验研究院、省医疗器械检验所10个驻外检验室建设。支持省内具备条件的医疗器械第三方检验机构申请国家资质认定，承担注册检验任务。推动省医疗器械检验所再扩增16项医用电气设备GB9706系列标准检验资质。发挥常州新北、苏州昆山、无锡宜兴等医疗器械服务站作用，为企业提供检验检测咨询指导服务。 （九）提升服务便利化水平。落实“一网通办”，推行申报资料电子化、标准化、模板化，探索运用智能比对、数据分析等技术提升审评审批效率。对第二类医疗器械创新注册、优先注册等情形，设置便捷通道，开展集中会审、同步核查、优先注册检验。将检验、审评和核查等环节由串联变为并联，对简单事项实行即到即办，对关联事项实行同审同办。加强审评核查分中心赋权管理，组织开展赋权增项，就近服务地方产业发展。支持自贸区及其联动创新发展区开展生物医药研发用物品进口“白名单”制度试点。 （十）规范药品领域市场秩序。开展药品安全专项整治，集中打击整治危害药品安全违法犯罪行为。进一步落实涉疫药品和医疗用品稳价保质专项行动实施方案有关工作要求，保障涉疫药品和医疗器械质量安全。开展风险信用监管，综合运用书面检查、远程非现场检查等多种手段，减少对企业的现场检查频次。落实行政处罚法、长三角地区市场监管部门和省市场监管局关于轻微违法不罚、初次违法不罚、无主观过错不罚、从轻减轻处罚等相关规定，探索柔性执法、说理式执法。 （十一）对上争取政策支持。建立与国家药监局常态化汇报沟通机制，选派人员赴国家药监局相关司局、直属单位挂职学习，精准掌握上级政策要求。全面梳理全省医药产业重点项目，实施清单式管理，及时跟踪研发上市进度，指导企业加强沟通对接，推动一类创新药、新冠治疗药物、创新医疗器械等重点产品加快获批。 三、健全完善服务发展保障措施 （十二）完善“面对面”服务机制。加强对各设区市医药产业情况研究分析，摸排整理问题诉求清单，开展省委、省政府促进产业发展政策措施、药品监管法律法规、省药监局优化审评审批服务具体举措等宣传解读，拓展“苏药e家”系统功能，为各地提供高效精准“面对面”服务（具体方案见附件）。 （十三）加强部门协同联动。发挥省药品安全委员会及其办公室职能作用，针对药品医疗器械研发、临床试验、注册上市、经营使用等事项，开展部门会商，完善政策衔接。加强与国家药监局、长三角分中心“一网通办”事项业务交互，强化医疗、医保药品数据衔接应用，实现数据共享、业务协同。 （十四）强化督查督办。对企业问题诉求实施“清单式”管理、“对账销号式”落实，明确时间表和路线图，扣紧责任链条，对办理情况及时督查督办、跟踪问效。对久拖未办、推诿扯皮、无正当理由未按时办结的事项，严肃追责问责。 附件：2023年省药监局“面对面”对接服务活动方案 附件 2023年省药监局“面对面”对接服务活动方案 一、省药监局领导挂钩服务各设区市计划安排表 局领导 挂钩 设区市 挂钩服务牵头处室 处室 负责同志 联络员 田丰 苏州 办公室、行政审批处 杨奇 沈晓洁 夏晨 简祖强 姜伟 南京 行政审批处 沈晓洁 简祖强 徐州 行政审批处 丁峰 简祖强 常州 行政审批处 常林凤 简祖强 陈和平 南通 医疗器械生产监管处 张大威 冯志远 扬州 医疗器械生产监管处 张大威 冯志远 泰州 医疗器械生产监管处 张大威 冯志远 于萌 无锡 药品生产监管处 殷志勇 许慧 镇江 药械经营监管处 张坤 周静 张春平 淮安 化妆品监管处 王宗敏 周家杰 宿迁 政策法规处 倪永兵 张雪莉 万煜华 连云港 稽查处 衡萍 单楚飞 盐城 稽查处 刘雨治 闫亮 二、活动流程 （一）活动准备 以优化产业布局，服务指导企业，加速创新产品上市为主导，由“末端提速”转变为“前端帮扶，全程提速”。聚焦各市医药产业发展规划和现状，收集整理重点医药园区和重点项目的帮扶建议，形成个性化对接服务方案。（各设区市市场监督管理局、省局各检查分局、省局审评核查各分中心负责） （二）现场活动 局领导带队，实地走访各市重点园区和企业，召开座谈会。 1.情况通报。2022年各设区市新获批上市药品和第二、三类医疗器械产品情况；有审评核查分中心的设区市，通报2022年分中心受理和一类赋权事项办理情况；2022年“面对面”对接服务活动收集企业诉求的反馈情况；在相关设区市（无锡、徐州、泰州）通报5个涉药领域重点外资外贸项目全过程跟踪服务情况等。（行政审批处负责） 各牵头处室可增加通报内容。（各牵头处室负责） 2.政策解读。省局贯彻落实省政府《关于推动经济运行率先整体好转的若干政策措施》（苏政规〔2023〕1号）、省政府办公厅《关于优化审评审批服务推动创新药械使用促进医药产业高质量发展的行动方案（2022－2024年）》（苏政办发〔2022〕1号）相关举措，以及省局“提速畅通工程”具体内容；2023年国家药监局第三类重点创新医疗器械审评相关政策；江苏省医疗器械创新服务站与国家药监局医疗器械技术审评中心及长三角分中心对接工作机制；有源医疗器械GB9706贯标要求等。（行政审批处负责） 对无锡、徐州、常州、苏州、连云港、泰州6个设区市，解读分中心第二、三类审评核查事项赋权有关标准要求；对南京、南通、扬州3个设区市，解读分中心首次赋权条件、事项及考核要求。解读我省实施第二类有源医疗器械拟上市注册立卷审查要求等。（行政审批处牵头，省局审评中心、省局审核查验中心负责） 各牵头处室可增加政策解读内容。（各牵头处室负责） 3.交流互动。与重点医药产业园区交流产业发展现状、存在问题、下一步发展方向及需要省级层面指导支持的事项；与重点医药企业交流产品研发生产监管等情况，现场听取解答企业问题和诉求；现场征求对省局职能处室、直属单位、检查分局、审评核查分中心改进工作作风、勤政廉政等方面的意见建议。（各牵头处室负责） 日常通过“苏药e家”线上服务平台收集各园区、企业诉求建议并反馈。（行政审批处负责） （三）活动总结和宣传 现场活动结束后及时做好问题梳理、解决和跟踪反馈等工作，做到闭环管理，全面提升“面对面”对接服务影响力，助力生物医药领域经济运行率先整体好转。 相关链接：省局召开深化“面对面”对接服务推动生物医药领域经济运行率先整体好转新闻发布会