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关于开展生物医药人体临床试验责任保险、产品责任保险工作的通知

Notice on the Implementation of Liability Insurance for Clinical Trials of Biopharmaceuticals in Humans and Product Liability Insurance
沪科合〔2025〕28号
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 · 46 relationships

Argentina: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 86,316,738

Australia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 241,085,498

Austria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 319,567,657

Belgium: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 777,672,181

Bulgaria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 6,189,789

Brazil: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 23,718,698

Canada: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 328,587,149

Switzerland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 2,562,915,823

Cyprus: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 3,073,835

Czech Republic: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 1,072,786

Germany: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 7,362,599,137

Denmark: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 922,955,785

Egypt, Arab Rep.: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 2,325,400

Spain: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 594,084,265

Finland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 116,811,756

France: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 2,996,525,884

United Kingdom: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 1,366,164,334

Greece: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 257,862,272

Hong Kong, China: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 536,015,305

Hungary: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 66,901,420

Indonesia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 5,018,006

India: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 81,175,295

Ireland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 6,073,389,483

Israel: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 53,760,151

Italy: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 2,402,024,592

Japan: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 1,419,221,003

Korea, Rep.: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 149,153,424

Lithuania: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 2,169,734

Mexico: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 3,469,031

Malta: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 1,548,013

Netherlands: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 608,846,800

Norway: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 20,834,130

New Zealand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 61,353,271

Poland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 59,204,169

Romania: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 1,786,797

Russian Federation: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 2,638,576

Singapore: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 336,690,427

Slovenia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 17,189,196

Sweden: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 1,366,050,590

Thailand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 12,877,816

Chinese Taipei: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 231,646,496

Uruguay: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 25,423,673

United States: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 6,578,529,615

Vietnam: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 6,048,441

South Africa: Trade-based inference; exporters to China; summed product trade > USD 1m; 2022 trade; broad sector headings; computed, not analyst-reviewed · intervention 61903 · recorded trade USD 18,864,184

Implementing jurisdiction: China · intervention 61903

Assessment states
  • Trade-based partners recorded

Measures

Capital grant
Provincial · origin: Chinese firms or production in China · locality: Local firms · CPC 352 · in force from 2023-01-01 · until 2026-12-31 · Keyword screen (unreviewed)
Implemented by China (subnational) · affects 45 partners (inferred from trade data, 2022 trade): Germany, United States, Ireland, France, Switzerland, Italy …
市级财政资金安排对符合条件的主体保费给予50%的财政补贴,单个保单的补贴不超过50万元。
Supports production in a place, so favours that place by rule.

Full text

沪科合〔2025〕28号 各区科技行政主管部门,各有关单位: 为落实上海市人民政府《上海市人民政府办公厅关于支持生物医药产业全链条创新发展的若干意见》(沪府办规〔2024〕9号)、上海市人民政府办公厅《上海市加快打造全球生物医药研发经济和产业化高地的若干政策措施》(沪府办规〔2022〕13号)、上海市人民政府办公厅《上海市推进养老科技创新发展行动方案(2024-2027年)》(沪府办发〔2024〕8号)的要求,加快打造全球生物医药研发经济和产业化高地,推进本市养老科技创新发展,培育发展新动能,针对生物医药产品、养老科技产品投保人体临床试验责任保险、产品责任保险建立保费补贴机制,现就相关工作通知如下: 一、支持对象 在本市的生物医药人体临床试验申办者(个人除外)、医疗卫生机构及从事药品、医疗器械和养老科技产品研发、生产和销售的企业和机构,以及提供合同研发和生产服务的企业。 二、支持条件 (一)补贴范围 1.关于人体临床试验责任保险 药品为按现行《药品注册管理办法》注册分类的化学药品第1-3类;中药注册分类第1-4类;生物制品注册分类治疗用生物制品、预防用生物制品、按生物制品管理的体外诊断试剂。医疗器械为按现行《医疗器械分类规则》分类的第二类、第三类。医疗技术为现行《医疗技术临床应用管理办法》中明确的医学专业手段和措施。养老科技产品为按现行《上海市推进养老科技创新发展行动方案(2024-2027年)》重点推进开发的产品第1-6类。 2.关于产品责任保险 (1)在中国境内销售时间不超过5年的药品、医疗器械和养老科技产品; (2)药品为按现行《药品注册管理办法》注册分类的持有人生产或委托生产的化学药品第1-3类;中药注册分类第1-3类;生物制品注册分类治疗用生物制品、预防用生物制品第1-2类、按生物制品管理的创新型体外诊断试剂。医疗器械为按现行《医疗器械分类规则》分类的第三类。养老科技产品为《上海市推进养老科技创新发展行动方案(2024-2027年)》重点推进开发的产品第1-6类。 (二)补贴要求 1.企业或机构投保生物医药人体临床试验责任保险、产品责任保险,保单或批单的签单日期应在2023年1月1日至2026年12月31日期间。 2.企业或机构应信用状况良好,未被相关部门列为严重失信主体名单。 三、支持方式 市级财政资金安排对符合条件的主体保费给予50%的财政补贴,单个保单的补贴不超过50万元。 基于保险机构提供的投保材料,市科委以免申即享方式对符合补贴范围的投保企业或机构直接予以补贴。 市科委常年受理保费补贴审核,并向社会分批公示拟补贴结果清单,接受公众异议。 四、工作要求 (一)企业或机构须于投保后提前在全国信用信息公共服务平台(credit-gov.com)信用自查,若有失信记录请提前做好信用修复。 (二)免申即享的企业或机构于市科委公示结束后,须于收到通知的五个工作日内,在上海市科技金融信息服务平台(shtic.com/kjjr/)或者一网通办登录企业或机构账户,完成补贴信息确认,逾期视为自动放弃。 (三)企业或机构获保费补贴后申请退保,应退还对应补贴款。 (四)保险机构应持续跟进企业或机构投保后开展人体临床试验和药械研发、生产和销售的进展,对符合保费补贴要求的企业或机构信息应及时反馈,确认保费补贴名单按要求应报尽报,未反馈的企业或机构名单视为保险机构判断不符合保费补贴范围要求。 (五)保险机构应认真核实和完善企业或机构情况,确保企业或机构信息真实准确,符合补贴要求。如报送数据存在造假或者数据错误等情况,将视情况予以处理。 五、政策实施期限 本通知自发布之日起实施,有效期至2026年12月31日。《关于开展生物医药人体临床试验责任保险、生物医药产品责任保险工作的通知》(沪科合〔2024〕4号)自本文件发布之日起自动失效。 六、咨询方式 上海市生物医药科技产业促进中心 联系人:杜璇50800300-320 姚凌芸50800300-333 上海市科技创业中心 联系人:何敏霞53080900-340 特此通知。 上海市科学技术委员会 中共上海市委金融委员会办公室 国家金融监督管理总局上海监管局 2025年9月8日