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关于印发《浦东新区支持生物医药产业高质量发展专项操作细则》的通知

Notice on the Issuance of the ‘Special Operational Rules for Supporting the High-Quality Development of the Biopharmaceutical Industry in Pudong New Area’
浦科经委规〔2022〕9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 · 42 relationships

Argentina: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 38,790,484

Australia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 684,951,654

Austria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 352,535,473

Belgium: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 1,023,694,737

Bulgaria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 4,404,553

Brazil: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 34,262,753

Canada: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 734,896,211

Switzerland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 1,792,413,409

Cuba: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 1,260,002

Cyprus: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 8,891,420

Germany: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 8,744,173,605

Denmark: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 697,735,248

Spain: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 681,995,985

Finland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 175,211,539

France: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 2,362,704,307

United Kingdom: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 1,293,728,081

Greece: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 242,703,679

Hong Kong, China: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 288,415,194

Hungary: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 46,577,165

Indonesia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 5,905,266

India: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 65,551,100

Ireland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 2,499,783,826

Israel: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 29,146,636

Italy: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 2,201,389,222

Japan: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 1,245,943,671

Korea, Rep.: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 122,180,079

Lithuania: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 4,089,327

Mexico: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 4,239,722

Netherlands: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 393,721,090

Norway: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 63,939,425

New Zealand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 16,959,118

Poland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 63,479,822

Singapore: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 193,117,355

Slovenia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 17,551,873

Sweden: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 1,864,730,755

Thailand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 8,610,601

Chinese Taipei: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 219,121,691

Uruguay: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 5,528,228

United States: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 5,421,866,686

Vietnam: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 3,577,554

South Africa: Trade-based inference; exporters to China; summed product trade > USD 1m; 2020 trade; broad sector headings; computed, not analyst-reviewed · intervention 70109 · recorded trade USD 24,614,807

Implementing jurisdiction: China · intervention 70109

Assessment states
  • Trade-based partners recorded

Measures

Capital grant
Provincial · origin: Chinese firms or production in China · locality: Local firms · CPC 352 · until 2025-12-31 · Keyword screen (unreviewed)
Implemented by China (subnational) · affects 41 partners (inferred from trade data, 2020 trade): Germany, United States, Ireland, France, Italy, Sweden …
2、对获批上市的一类新药(含中医药)给予1000万元一次性奖励(包括临床Ⅱ期、Ⅲ期奖励),对获批上市的二类新药(含中医药)给予500万元一次性奖励。
Supports production in a place, so favours that place by rule.

Full text

上海市浦东新区科技和经济委员会上 海 市 浦 东 新 区 财 政 局 浦科经委规〔2022〕9号 关于印发《浦东新区支持生物医药产业高质量发展专项操作细则》的通知区政府各委、办、局,各管理局(管委会),各直属企业,各街道办事处、镇政府: 现将《浦东新区支持生物医药产业高质量发展专项操作细则》印发给你们,请按照执行。 上海市浦东新区科技和经济委员会 上海市浦东新区财政局2022年9月5日 信息公开属性:主动公开上海市浦东新区科技和经济委员会办公室 2022-09-07印发(共印70份) 浦东新区支持生物医药产业高质量发展专项操作细则 为贯彻落实《上海市人民政府关于促进本市生物医药产业高质量发展的若干意见》(沪府规〔2021〕5号)等文件,根据《浦东新区促进重点优势产业高质量发展若干政策措施》(浦府规〔2022〕5号),支持浦东新区生物医药和新材料产业高质量发展,特制定本操作细则。 一、资助对象工商注册地和税收户管地均在浦东新区的,符合本政策规定条件的生物医药、新材料企业,适用本政策。 二、资助内容 (一)支持创新药械研发 1、对新进入临床Ⅱ期、Ⅲ期研究的一类新药(含中医药)研发项目,分别给予100万元、200万元一次性奖励。 2、对获批上市的一类新药(含中医药)给予1000万元一次性奖励(包括临床Ⅱ期、Ⅲ期奖励),对获批上市的二类新药(含中医药)给予500万元一次性奖励。 3、对在全国同类仿制药中首个通过一致性评价的,给予200万元的一次性奖励。 4、对获得注册证的三类医疗器械、三类体外诊断试剂分别给予100万元、50万元一次性奖励。 (二)支持产业链协同联动 1、对药品、医疗器械上市前,委托区内企业生产临床用样品(药物)和临床用样机(器械),委托与受委托方无关联的,分别给予双方试生产合同金额各15%的支持,其中药品每家企业不超过100万元,医疗器械不超过50万元。 2、对药品获批上市或医疗器械获得注册证后一年内委托区内企业生产,委托与受委托方无关联的,分别给予双方生产合同金额各10%的支持,单个药品上市许可持有人、医疗器械注册人企业年度最高资助500万元,单个生产企业年度最高资助1000万元。 3、对药品获批上市或医疗器械获得注册证后一年内委托区外企业生产的,药品、医疗器械注册证以及税收、统计均落地浦东的,给予委托方合同金额10%的支持,单个药品上市许可持有人、医疗器械注册人企业年度最高资助500万元。 4、对获得 FDA(美国食品药品监督管理局)、EMA(欧洲药品管理局)、WHO(世界卫生组织)等国际药品生产质量管理规范认证的企业,给予200万元一次性奖励。 (三)配套支持对获得上海市级政策支持的生物医药及新材料项目,可在项目验收完成后,给予一定配套奖励。 对明确配套要求的,按市级部门立项时明确的区级支持要求给予配套支持。对未明确配套要求的,经区相关部门协商一致,按照企业获得的上海市级项目扶持资金总额,给予不超过企业获得上海市级项 目扶持资金50%的奖励。同一项目各级政府奖励和资助总额不超过企业总投入的50%,最高5000万元。 三、部门职责 1、各片区管理局、镇作为操作主体,负责申报受理、项目审核、过程监督和跟踪服务。 2、区科经委会同财政局等相关部门负责专项资金的计划安排、统筹协调和综合管理,发布政策年度申报指南、组织项目复核和联合会审。 3、区财政局负责专项资金的预算、拨付、监管,参与计划安排的拟定、统筹协调和综合管理。 4、区审计局负责对专项资金使用情况进行审计监督。 四、监督管理 1、项目监管各片区管理局、镇负责具体对获得专项资金支持的项目实施动态跟踪检查监管。 2、绩效评价各片区管理局、镇每年汇总完成上一年度项目实施效益情况和项目管理工作总结,区科经委会同财政局开展年度绩效评价工作。 五、应用解释及施行日期对既适用上级机关相关扶持规定,又适用本政策的,一律先执行上级机关规定,执行后与本政策相比不足部分,可补充执行。 本政策与区级其他各项政策按“从优不重复”原则执行。 本政策年度申报指南由区科经委统一发布。本政策自2022年 月 日起实施,有效期至2025年12月31日。2021年1月1日至2022 年月 日期间,符合本办法规定的,参照本办法执行。 本政策实施过程中如遇国家或上海市颁布新规定,则按新规定调整执行。