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

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 · 45 relationships

Australia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 78,328,169

Austria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 217,777,990

Belgium: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 11,573,843

Belarus: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 1,415,639

Brazil: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 2,734,651

Barbados: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 12,478,185

Canada: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 56,334,490

Switzerland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 493,019,892

Costa Rica: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 55,807,612

Czech Republic: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 2,366,613

Germany: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 2,220,665,020

Denmark: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 83,759,843

Dominican Republic: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 26,381,565

Spain: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 45,632,894

Finland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 61,443,531

France: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 313,508,986

United Kingdom: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 262,129,500

Hong Kong, China: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 2,619,959

Hungary: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 9,175,202

Indonesia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 16,295,881

India: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 79,683,650

Ireland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 495,775,296

Israel: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 185,476,557

Italy: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 203,964,780

Japan: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 1,275,313,639

Korea, Rep.: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 291,690,924

Mexico: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 372,750,381

Malaysia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 73,317,027

Netherlands: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 357,322,821

Norway: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 49,695,905

Nepal: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 1,010,607

New Zealand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 8,394,108

Pakistan: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 4,067,309

Poland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 14,390,595

Russian Federation: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 2,157,478

Singapore: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 175,405,214

Slovenia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 4,061,158

Sweden: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 123,371,173

Thailand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 26,237,902

Tunisia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 2,893,598

Turkey: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 7,641,177

Chinese Taipei: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 97,685,765

United States: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 4,031,719,531

Vietnam: Trade-based inference; exporters to China; summed product trade > USD 1m; 2014 trade; broad sector headings; computed, not analyst-reviewed · intervention 70935 · recorded trade USD 39,203,544

Implementing jurisdiction: China · intervention 70935

Assessment states

Trade-based partners recorded

Measures

Capital grant

Provincial · origin: Chinese firms or production in China · locality: Local firms · CPC 481 · Keyword screen (unreviewed)

Implemented by China (subnational) · affects 44 partners (inferred from trade data, 2014 trade): United States, Germany, Japan, Ireland, Switzerland, Mexico …

充分整合利用现有专项资金，重点向药品医疗器械标准研究管理和专业技术人员培训等方面倾斜。

Tells lower levels to act; not itself a measure in force. 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	this document	2015-12-04	117 d
Fujian	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	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

各市人民政府，省政府各厅委、各直属机构：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）精神，提高审评审批效率，推动药品医疗器械产业创新，保障上市药品和医疗器械安全有效，推进药品医疗器械产业健康快速发展，现提出以下实施意见。一、形成改革合力，推动药品医疗器械产业健康发展（一）强化企业主体责任，提升药品医疗器械研发创新能力。引导企业按照新的创新药和仿制药标准开展研发工作，全面提高申报资料质量；按照新的审评审批规范加强自身管理，严格履行申报人主体责任；按照鼓励创新的原则，对企业未来发展方向进行重新调整、规划和定位，促进我省医药行业由仿制药（仿制医疗器械）为主向仿创结合、自主创新为主转变，不断提高全省药品医疗器械生产企业自主创新能力和产业竞争力。（省食品药品监管局负责）（二）加大政策扶持力度，促进药品医疗器械产业健康发展。鼓励开展仿制药质量一致性评价。对于通过质量一致性评价的仿制药，允许其在说明书和标签上予以标注，并在临床应用、招标采购、医保报销等方面给予支持。加大对重大药品、医疗器械创新研发项目支持力度；对重大创新药品医疗器械、首仿药、临床急需产品，提前介入，专人跟踪，注册检验实行加急程序，快速审查审批；将拥有产品核心技术发明专利以及国内领先技术、在国内占有显著市场份额企业的医疗器械注册申请列入特殊审评审批范围，予以优先办理。鼓励优势企业实施跨地区、跨所有制兼并重组。支持外省企业迁入，对于符合医药产业政策的外省企业迁入省内，及时办理相关手续，帮助企业尽快落地达产。支持药品生产企业间产品技术转让。为省内企业搭建产品技术转让信息平台，促进企业间批准文号的有序流动。（省食品药品监管局牵头负责，省发展改革委、省经济和信息化委、省人力资源社会保障厅、省卫生计生委、省科技厅等部门配合）二、优化审批机制，依法依规履行监管责任（一）健全审评质量控制体系。落实良好审评指南管理规范。提高技术审评项目团队专业化水平，明确主审人和审评员权责，建立基于风险的审评机制，完善集体审评制度，强化责任和时限管理。建立复审专家委员会，对有争议的审评结论进行复审，确保审评结果科学公正。制定审评技术规范，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。（省食品药品监管局负责）（二）推进审评审批全过程公开。公开药品医疗器械审批清单及法律依据、审批要求、办理时限、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。逐步建立完善信用体系，公开相关企业、机构信用情况，将存在弄虚作假行为的单位和直接责任人纳入失信名单，向社会公布，在规定时间内对其药品医疗器械注册申请不予受理。（省食品药品监管局负责）（三）落实审评审批属地责任。按照最严谨的标准、最严格的监管、最严厉的处罚、最严肃的问责要求，落实全省药品医疗器械监管部门审评审批属地责任。严格执行药品再注册有关规定，不符合条件的不予再注册，并上报国家食品药品监督管理总局注销批准文号。对地方承担的注册申请受理、现场检查、产品检验等工作，进一步规范程序标准，建立责任追究制度，对申请人和监管人员弄虚作假行为依法从严处理。（省食品药品监管局负责）三、强化保障措施，加强审评审批能力建设（一）加强省级药械审评与监测中心、药品认证中心建设。合理核定人员编制，科学构建技术审评、检查岗位体系，建立首席专业岗位制度，明确职责任务、工作标准和任职条件等，依照人员综合能力水平实行按岗聘用。创新用人制度，面向社会招聘技术审评、现场检查人才，实行合同管理，其工资和社会保障按照国家有关规定执行。健全绩效考核制度，根据岗位职责和工作业绩，适当拉开收入差距，确保技术审评、检查人才引得进、留得住、用的好。通过政府购买服务，选择符合条件的审评机构、高校和科研机构参与药品医疗器械技术审评、临床试验审评、药物安全性评价等技术性审评工作。（省食品药品监管局牵头负责，省编委办、省人力资源社会保障厅等部门配合）（二）调整收费政策，加大财政投入。按照收支大体平衡的原则，制定省级药品医疗器械注册收费标准，每五年调整一次；同步制定小微企业收费政策，对小微企业申请创新药品医疗器械注册收费给予适当优惠。收费收入纳入财政预算，实行收支两条线管理，审评审批工作所需经费通过财政预算安排；充分整合利用现有专项资金，重点向药品医疗器械标准研究管理和专业技术人员培训等方面倾斜。（省财政厅、省物价局负责）（三）加强审评员、检查员队伍建设，提高专业化水平。建立人员培养长期规划，强化审评员梯队建设，加快构建一支专业匹配、能力适合、数量充足的审评员队伍，不断加强审评人员理论培训和实操训练，丰富审评员知识体系，掌握前沿科技，满足审评工作需要；推进职业化检查员队伍建设，不断提升检查员队伍的整体水平。（省食品药品监管局牵头负责，省人力资源社会保障厅等部门配合）四、加强组织领导省食品药品监管局要与机构编制、发展改革、经济和信息化、科技、财政、人力资源社会保障、卫生计生、物价等部门，建立沟通协调机制，加强对本实施意见落实工作的检查指导，及时研究解决改革中遇到的矛盾问题，形成工作合力。各有关部门和单位要各负其责，抓紧研究制定具体措施，明确路线图和时间表，细化分解任务，落实责任分工，切实将国务院和省政府关于改革药品医疗器械审评审批制度的各项部署要求抓紧抓实抓好。辽宁省人民政府 2015年12月4日