Waitan Ludi Policy Terminal

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 · 41 relationships

Argentina: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 63,392,020

Australia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 511,843,539

Austria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 324,040,580

Belgium: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 316,712,430

Bulgaria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 3,537,672

Brazil: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 35,841,444

Canada: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 155,566,257

Switzerland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 1,032,198,911

Cuba: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 2,518,496

Cyprus: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 38,646,599

Germany: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 4,321,136,622

Denmark: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 520,596,982

Spain: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 358,113,178

Finland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 144,578,142

France: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 1,594,197,817

United Kingdom: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 1,094,344,667

Greece: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 42,713,366

Hong Kong, China: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 347,934,374

Croatia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 3,234,299

Hungary: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 89,825,936

Indonesia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 1,748,400

India: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 19,009,740

Ireland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 540,672,207

Iceland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 1,051,132

Israel: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 19,621,174

Italy: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 1,562,024,689

Japan: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 684,616,692

Korea, Rep.: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 140,423,507

Mexico: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 2,694,738

Netherlands: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 281,939,920

Norway: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 28,858,102

New Zealand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 6,921,525

Poland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 73,258,649

Singapore: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 46,048,832

Slovenia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 3,573,612

Sweden: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 794,800,488

Thailand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 7,667,337

Chinese Taipei: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 113,998,224

United States: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 3,049,058,406

South Africa: Trade-based inference; exporters to China; summed product trade > USD 1m; 2015 trade; broad sector headings; computed, not analyst-reviewed · intervention 66691 · recorded trade USD 70,616,599

Implementing jurisdiction: China · intervention 66691

Assessment states

Trade-based partners recorded

Measures

Capital grant

Provincial · origin: Chinese firms or production in China · locality: Local firms · CPC 352 · Keyword screen (unreviewed)

Implemented by China (subnational) · affects 40 partners (inferred from trade data, 2015 trade): Germany, United States, France, Italy, United Kingdom, Switzerland …

重点推进在审创新药品种聚乙二醇长效干扰素a2b、宫颈癌疫苗和尖锐湿疣疫苗等一类生物制品早日上市，积极帮扶我省在研创新药品种抗乙肝核苷酸药“艾格威”、红景天苷和卢帕替芬等加快研发申报进程，对符合条件的新药按《福建省人民政府关于加快医药产业发展十二条措施的通知》（闽政文〔2014〕98号）第三条款给予补助。

Supports production in a place, so favours that place by rule.

Same central policy, other provinces

国务院关于改革药品医疗器械审评审批制度的意见 · 国发〔2015〕44号 · 2015-08-09 · answered in 4 provinces held · trace it ↗

Province	First document citing it	Dated	Lag
Liaoning	辽宁省人民政府关于改革药品医疗器械审评审批制度的实施意见	2015-12-04	117 d
Fujian	this document	2016-02-16	191 d
Beijing	北京市医疗器械快速审评审批办法(试行)	2016-08-18	375 d
Guangdong	广东省人民政府办公厅转发国务院办公厅关于开展仿制药质量和疗效一致性评价意见的通知	2016-10-09	427 d

Held documents only: these are counts of what we have collected, not of what each province issued.

Full text

各市、县（区）人民政府，平潭综合实验区管委会，省人民政府各部门、各直属机构，各大企业，各高等院校：为贯彻落实《国务院关于改革药品医疗器械审评审批制度的意见》（国发〔2015〕44号，以下简称《意见》），提高药品医疗器械研发水平，促进医药产业发展，现结合我省药品医疗器械审评审批实际提出以下实施意见。一、提升审评审批能力，提高审评审批质量按照国家与省药品医疗器械审评审批职能事权划分，加强药品医疗器械审评能力建设，建立更加科学高效的药品医疗器械审评审批运行体系，争取国家相关部委支持，积极做好国家药品医疗器械审评审批下放事项的承接准备工作，简化优化我省药品医疗器械的审评审批程序，实现各环节有序衔接，提高审评审批效率和质量，使我省批准上市的药品医疗器械有效性、安全性、质量可控性达到或接近国内国际先进水平。责任单位：省食品药品监管局，各设区市人民政府、平潭综合实验区管委会二、推进仿制药质量一致性评价，提高仿制药品质量加快仿制药质量和疗效一致性评价工作。引导、督促省内药品生产企业对已批准上市的仿制药，按与原研药品质量和疗效一致的原则，分期分批进行质量一致性评价。加速推进我省医疗机构与研发机构联合筹建人体药代动力学研究和生物等效性评价试验室的步伐，填补省内Ⅰ期临床试验室空白。严格执行国家规定，对在规定期限内未通过质量一致性评价的仿制药不予再注册。对2007年10月1日前批准的国家基本药物目录中化学药品仿制药口服固体制剂，应在2018年底之前完成一致性评价。凡通过国家仿制药质量一致性评价的药品，在临床应用、招标采购、医保报销、银行贷款等方面给予优先支持。激励企业通过技术进步开展已批准工艺的优化研究，提高上市药品的标准和质量。凡提出相关补充申请的，省食品药品监管局要设立绿色通道予以支持，全面提高我省已上市药品整体质量。责任单位：省食品药品监管局、发改委、经信委、卫计委、科技厅、人社厅，各设区市人民政府、平潭综合实验区管委会三、推进我省创新药的研发和产业化各级各有关部门要制定重大新药创制帮扶计划，鼓励以临床价值为导向的防治艾滋病、恶性肿瘤、重大传染病、罕见病等疾病的创新药，以及儿童用药和先进制剂技术等新药的研发，提前介入，开展风险评估，开辟快速通道，指定专人跟踪服务，密切与国家食品药品监管总局及相关部委沟通协调，积极争取列入国家科技重大专项和特殊审评程序，积极争取小微企业申报创新药的注册收费减免。重点推进在审创新药品种聚乙二醇长效干扰素a2b、宫颈癌疫苗和尖锐湿疣疫苗等一类生物制品早日上市，积极帮扶我省在研创新药品种抗乙肝核苷酸药“艾格威”、红景天苷和卢帕替芬等加快研发申报进程，对符合条件的新药按《福建省人民政府关于加快医药产业发展十二条措施的通知》（闽政文〔2014〕98号）第三条款给予补助。责任单位：省食品药品监管局、发改委、经信委、卫计委、科技厅，人民银行福州中心支行，各设区市人民政府、平潭综合实验区管委会四、推进我省上市许可持有人制度试点工作积极推进药品上市许可持有人制度试点工作，鼓励我省研发机构和科研人员作为药品上市许可持有人申请新药注册，允许药品上市许可持有人依申请变更委托的生产企业，充分调动研发者的积极性，加速研发创新，优化资源配置，抑制产业重复建设。各级各有关部门要抢抓机遇，制定相应优惠政策和措施，积极吸引海归研发团队和外省研发机构到我省创业，鼓励研发机构和科研人员独立申报优势品种注册新药，在转让给企业生产时，只进行生产企业现场工艺核查和产品检验，不再重复进行药品技术审评。鼓励我省优势制药企业积极承接上市许可人委托项目，多头并举，提升我省医药产业的核心竞争力。试点工作在依照法定程序取得授权后开展。责任单位：省食品药品监管局、发改委、经信委、商务厅，各设区市人民政府、平潭综合实验区管委会五、强化药品研发过程的日常监管要进一步加大药品注册现场核查监管的力度，加强药品医疗器械核查队伍能力建设，进一步规范注册核查的程序，完善药品注册现场核查的监督机制，提高核查队伍的能力和水平，支持GLP（药物非临床试验管理规范）、GCP（药物临床试验管理规范）药物研发平台和药物临床试验平台建设，鼓励省内临床试验机构参与国际多中心临床试验。加强临床试验全过程监管，确保临床试验数据真实可靠，强化申请人、临床试验机构及伦理委员会保护受试者的责任。同时要制定药物非临床和临床试验机构日常监管制度和年度工作方案，将药物非临床试验和临床试验监管纳入常态化监管的轨道。对报送虚假资料和样品的申请人建立不良行为记录，在规定期限内不受理其申请。严把药品上市安全有效的第一关口。责任单位：省食品药品监管局、卫计委，各设区市人民政府、平潭综合实验区管委会六、推进医疗器械审评审批改革鼓励我省医疗器械企业研发创新，大力支持我省医疗器械生产企业加强高端诊疗器械研发，将拥有产品核心技术专利、具有重大临床价值的创新医疗器械注册申请列入特殊审评审批范围。对省食品药品监管局受理审批的第二类医疗器械产品，通过早期介入、专家帮促、专人负责、加强与申请人沟通等办法，按照医疗器械审评技术指导原则，在保证审批质量的前提下，优化审批流程，加快审批进度，将省食品药品监管局审批事项时限提速到原法定时限的60%。做好承接国家食品药品监管总局下放的部分成熟、安全可控的医疗器械注册审批工作。通过全面加强我省医疗器械审评能力建设，积极争取国家食品药品监管总局将部分三类医疗器械委托我省食品药品监管部门审评审批。同时对国家授权由省级审评审批的医疗器械产品，按要求公开医疗器械审评审批信息。责任单位：省食品药品监管局七、加强药品医疗器械审评认证机构队伍建设进一步加强各级审评认证队伍建设。改革事业单位用人制度，面向社会招聘人才，实行合同管理，其职称工资和社会保障应与编内员工待遇等同。科学设置岗位体系，明确职责任务，按岗聘用人员。健全绩效考核制度，积极推进全省药品医疗器械认证审评中心基础设施和能力建设。组建省药品医疗器械专家委员会及专业化技术审评团队，加强药品医疗器械质量安全的风险研判，加强技术审评过程中共性疑难问题研究，及时将研究成果转化为指导审评工作的技术标准，提高审评标准化水平，减少审评自由裁量权。建立职业化的审评员、检查员队伍，加强培训，强化管理，以适应我省新形势下监管和促进产业发展的需要，为我省食品药品监管工作提供强有力的技术支撑，为承接国家食品药品监管总局部分审评审批权限的下放打下良好的基础。责任单位：省人社厅、食品药品监管局，各设区市人民政府、平潭综合实验区管委会八、加强药品医疗器械检验机构能力建设各级各有关部门要进一步加强检验队伍建设，加强检验检测机构的基础设施建设，培养一支技术权威的专家队伍，以适应我省新形势下监管和产业发展的需要。加强药品医疗器械检验检测基础设施设备建设，加快省食品药品质量检验研究院搬迁建设工作，积极开展相关生物制品和有源医疗器械检验检测增项工作，全面提升我省药品医疗器械检验检测能力，为我省药品医疗器械注册检验和日常监管提供强有力的技术保障。责任单位：省食品药品监管局、发改委、财政厅，各设区市人民政府、平潭综合实验区管委会九、全面公开药品医疗器械审评审批信息及时向社会公布药品医疗器械审批要求、办理时限和法律依据，向申请人公开药品医疗器械审批进度和结果。在批准产品上市许可时，同步公布审评、检查、检验等技术性审评报告，接受社会监督。责任单位：省食品药品监管局十、加强组织领导和工作保障各级政府要加强对药品医疗器械审评审批制度改革工作的领导，支持食品药品监督管理部门工作，定期听取食品药品监督管理部门有关工作的汇报，合理配置药品医疗器械审评审批职责所需要的工作力量，及时研究解决药品医疗器械审评审批工作中遇到的突出问题。各级各有关部门要对重大新药创制、品种转移、仿制药质量和疗效一致性评价等项目给予科技、技改、产业化以及土地税收等政策和财政金融的扶持，为落实国务院《意见》提供有力的工作保障。责任单位：各设区市人民政府、平潭综合实验区管委会，省食品药品监管局、发改委、经信委、卫计委、科技厅、财政厅、商务厅福建省人民政府 2016年2月16日

Ask the evidence.

福建省人民政府关于改革药品医疗器械审评审批制度的实施意见

Country-interest evidence · pilot

Measures

Same central policy, other provinces

Full text