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吉林省人民政府公报

吉政办发〔2018〕36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 · 43 relationships

Argentina: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 68,184,646

Australia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 618,891,566

Austria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 358,810,322

Belgium: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 590,678,951

Bulgaria: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 6,021,604

Brazil: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 46,580,181

Canada: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 181,300,594

Switzerland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 1,358,551,546

Cuba: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 2,366,120

Cyprus: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 31,321,155

Germany: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 6,734,171,707

Denmark: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 549,005,874

Spain: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 441,744,613

Finland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 154,379,223

France: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 2,310,444,459

United Kingdom: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 1,166,113,342

Greece: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 111,570,202

Hong Kong, China: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 375,926,467

Croatia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 6,690,794

Hungary: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 86,744,660

Indonesia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 2,503,424

India: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 22,172,944

Ireland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 750,566,329

Israel: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 21,854,855

Italy: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 1,835,757,872

Japan: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 866,692,641

Korea, Rep.: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 141,837,898

Lithuania: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 1,277,721

Mexico: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 9,412,622

Netherlands: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 305,319,120

Norway: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 30,963,788

New Zealand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 17,019,606

Poland: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 31,617,816

Russian Federation: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 1,415,686

Singapore: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 62,461,850

Slovenia: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 16,552,563

Sweden: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 1,291,085,679

Thailand: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 7,882,552

Chinese Taipei: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 205,461,971

Uruguay: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 1,601,931

United States: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 3,532,200,082

South Africa: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 68976 · recorded trade USD 106,623,326

Implementing jurisdiction: China · intervention 68976

Assessment states
  • Trade-based partners recorded

Measures

Tax relief
Provincial · origin: Chinese firms or production in China · locality: Local firms · CPC 352 · Keyword screen (unreviewed)
Implemented by China (subnational) · affects 42 partners (inferred from trade data, 2017 trade): Germany, United States, France, Italy, Switzerland, Sweden …
落实现行税收优惠政策,仿制药企业为开发新技术、新产品、新工艺产生的研发费用,符合条件的按照有关规定在企业所得税税前加计扣除。
Supports production in a place, so favours that place by rule.

Same central policy, other provinces

国务院办公厅关于改革完善仿制药供应保障及使用政策的意见 · 国办发〔2018〕20号 · 2018-03-21 · answered in 6 provinces held · trace it ↗
ProvinceFirst document citing itDatedLag
Liaoning 辽宁省人民政府办公厅关于改革完善仿制药供应保障及使用政策的实施意见 2018-06-11 82 d
Fujian 福建省人民政府办公厅关于改革完善仿制药供应保障及使用政策的实施意见 2018-08-02 134 d
Jilin this document 2018-09-12 175 d
Guangdong 广东省人民政府办公厅关于印发广东省改革完善仿制药供应保障及使用政策实施方案的通知 2018-10-30 223 d
Anhui 安徽省人民政府办公厅关于改革完善仿制药供应保障及使用政策的实施意见 2018-11-21 245 d
Chongqing 重庆市人民政府办公厅关于印发重庆市改革完善仿制药供应保障及使用政策实施方案的通知 2018-11-27 251 d
Held documents only: these are counts of what we have collected, not of what each province issued.

Full text

吉林省人民政府办公厅 关于改革完善仿制药供应保障及 使用政策的实施意见 吉政办发〔2018〕36号 各市(州)人民政府,长白山管委会,长春新区管委会,各县(市)人民政府,省政府各厅委办、各直属机构: 为深入贯彻落实《国务院办公厅关于改革完善仿制药供应保障及使用政策的意见》(国办发〔2018〕20号),促进仿制药研发,提升仿制药质量疗效,提高药品供应保障能力,更好地满足临床用药及公共卫生安全需求,经省政府同意,现提出以下意见: 一、促进仿制药研发 (一)增强仿制药研发能力。发挥已有省生物药和化学药产业技术创新战略联盟作用,加强产学研合作攻关,提升仿制药科技创新及产业化的能力和水平。加强研发过程中新技术、新剂型的引进与成果转化,以及生产过程中质量控制技术、新工艺和新剂型等的引进与成果转化。(省科技厅、省食品药品监管局按职责分工负责) 引导企业不断加大研究和开发投入,加快新产品研发和已上市产品的继续研究。支持企业建立技术创新中心、中试平台,推动省内药品生产企业与国内外科研单位、高等院校、合同研究组织(CRO)合作,建立产学研医用协作研发机制。坚持鼓励创新与促进药品仿制研发并重的原则,鼓励仿制临床必需、疗效确切、供应短缺的药品,鼓励仿制重大传染病防治和罕见病治疗所需药品、处置突发公共卫生事件所需药品、儿童使用药品以及专利到期前一年尚没有提出注册申请的药品。(省食品药品监管局、省科技厅按职责分工负责) (二)开展仿制药关键技术研究。加快推进仿制药共性关键技术开发与产业化,在省级科技计划项目中予以倾斜。发挥企业的主导作用和科研机构、医疗机构、高等院校、产业联盟的基础支撑作用,整合省内药物研发资源,开展药用原辅料、包装材料和制剂技术的研究。省内药品生产企业应按照仿制药一致性评价的技术要求,主动选购参比制剂并开展相关研究,解决影响仿制药内在质量的工艺技术问题,确保研究数据真实、完整、准确,在质量和疗效上达到与原研药品一致。(省科技厅、省食品药品监管局按职责分工负责) (三)加强对仿制药研发的帮扶指导。建立仿制药研发早期介入机制,对仿制药研发和注册实行全程跟踪服务,落实专人负责。提前介入仿制药的研究,跟踪研发进程,在研发不同阶段进行沟通交流,帮助企业解决研发过程中技术问题,指导和规范仿制药的研究和注册申报,积极向国家审评审批部门协调汇报情况,符合条件的申请享受优先审评审批政策,推进注册审评审批速度。(省食品药品监管局、省科技厅按职责分工负责) (四)完善药品知识产权保护。开展科技创新驱动政策宣讲培训,重点推动企业(含医药研发和生产企业)提升专利申请质量。促进全省医药领域专利申请的数量与质量双提升,不断提高医药领域科研和管理人员的知识产权保护意识和水平。加大医药领域专利行政执法力度,调处专利侵权纠纷,查处假冒专利行为,维护良好的市场秩序。针对有需求的医药企业,免费开放新一代行业专利专题数据库,并定期公布医药领域新授权发明专利数据,保障医药企业免费或低成本获得专利信息资源,为政府决策和行业发展提供风险提示。(省知识产权局牵头负责) 二、提升仿制药质量疗效 (一)加快推进仿制药一致性评价。对省内已经批准上市的仿制药,按与原研药品质量和疗效一致的原则,分期分批进行一致性评价,全面提升仿制药质量水平。启动全省注射剂再评价工作,对省内注射剂品种进行筛选,开展注射剂再评价方法的研究。支持生物类似药、具有临床价值的药械组合产品的仿制,提高公众用药可及性。建立对通过一致性评价药品的支持政策和激励机制,积极引导企业开展一致性评价研究,及时向社会公布通过评价药品的信息。(省食品药品监管局、省工业和信息化厅、省科技厅按职责分工负责) (二)释放临床试验资源。支持具备条件的医疗机构、高等院校、科研机构和社会办检验检测机构参与一致性评价工作,鼓励社会资本在我省投资设立临床试验机构,引进国内外知名企业、药品研发机构及合同研究组织(CRO)参与临床试验机构建设和管理,拓宽临床试验渠道。改进临床试验管理方式,提高医疗机构和研究人员参与临床试验的积极性,指导临床试验机构加强能力建设,完善伦理审查制度,扩充I期试验研究室,提高药物临床试验水平,满足仿制药临床试验需求。(省食品药品监管局、省卫生计生委按职责分工负责) (三)提高药用原辅料和包装材料质量。充分利用我省化工原料的优势,开发药用新剂型,改善药品性能,提高药品制剂质量,发展化学原料药、新型药用辅料和新型包装系统,淘汰落后技术和产能。实行药品与药用原辅料和包装材料关联审批,加强对药用原辅料和包装材料的质量监管,提高原辅料和包装材料质量标准,指导药品生产企业围绕制剂的质量要求选择合适的原辅料和包装材料,与原辅料和包装材料生产企业建立稳定的质量保障关系,对所选择的原辅料和包装材料质量负责。(省食品药品监管局牵头负责) (四)提高仿制药工艺制造水平。充分挖掘药品生产加工潜力,整合各类生产要素资源,提升仿制药加工配套能力。做好新产品、新技术和已有产能对接,吸引更多上市许可持有人来我省委托加工,盘活闲置产能,促进产业结构调整和优化升级。推广应用新技术,优化和改进工艺生产管理,强化全面质量控制,提升关键工艺过程控制水平,推动解决制约产品质量的瓶颈问题。推进药品生产质量控制信息化建设,实现生产过程实时在线监控。(省食品药品监管局、省工业和信息化厅按职责分工负责) (五)加强仿制药质量监管。加快建立覆盖仿制药全生命周期的质量管理和质量追溯制度,加强对药物研发、生产、流通及使用过程的监督检查,加强不良反应监测和质量抽查,严肃查处数据造假、偷工减料、掺杂使假等违法违规行为,强化责任追究,检查和处罚结果向社会公开。按照“双随机,一公开”要求,依法组织开展各类药品检查,综合运用好检查、检验、监测和稽查手段,严厉打击违法违规生产经营行为,规范药品生产经营秩序。(省食品药品监管局牵头负责) 三、完善支持政策 (一)促进仿制药替代使用。坚持质量优先、价格合理的原则,鼓励医疗机构优先采购使用通过临床综合评价、疗效一致性评价的仿制药。将能够替代原研药的仿制药纳入医疗机构采购使用目录,便于医务人员和患者选择使用。落实处方点评制度,规范药品按通用名开具处方行为,建立健全仿制药合理使用考核奖惩机制,对不合理用药的处方医生进行公示,落实约谈制度。按规定向艾滋病、结核病患者提供药物时,优先使用通过一致性评价的仿制药。支持符合条件的医疗机构参与仿制药临床综合评价、疗效一致性评价工作,对临床使用量大、金额占比高的品种优先开展、加快进度,探索将评价结果作为药品采购、临床用药的重要参考。(省卫生计生委、省食品药品监管局、省公共资源交易中心按职责分工负责) (二)发挥基本医疗保险的激励作用。按国家要求制定医保药品支付标准,与原研药质量和疗效一致的仿制药、原研药按相同标准支付。建立完善基本医疗保险药品目录动态调整机制,按国家规定及时将符合条件的药品纳入目录。对基本医疗保险药品目录中的药品,不得按商品名或生产厂家进行限定,要及时更新医保信息系统,确保批准上市的仿制药同等纳入医保支付范围。通过医保支付激励约束机制,鼓励医疗机构使用仿制药。(省人力资源社会保障厅牵头负责) (三)落实税收优惠政策和价格政策。落实现行税收优惠政策,仿制药企业为开发新技术、新产品、新工艺产生的研发费用,符合条件的按照有关规定在企业所得税税前加计扣除。仿制药企业经认定为高新技术企业的,减按15%的税率征收企业所得税。各级税务部门要积极贯彻落实各项税收优惠政策,促进企业创新发展。同时结合全省工作实际,大力推进简政放权,不断优化办税流程,为全省高新技术企业的健康发展全力服务。加强对我省仿制药品市场价格监测和市场巡查力度,依法严厉打击原料药价格垄断等违法违规行为。(省税务局、省财政厅、省发展改革委、省物价局、省食品药品监管局按职责分工负责) (四)做好宣传引导。各地、各相关部门要按照职责分工,主动作为,敢于担当,精心组织实施,确保改革措施落地生效。要做好政策宣传解读,普及药品知识和相关信息,提升人民群众对国产仿制药的信心。通过处方点评与合理用药培训等方式,扩大药事服务广度和深度,提高群众科学用药、合理用药意识和素养等。 吉林省人民政府办公厅 2018年9月12日