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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

Notice of the General Office of the People’s Government of Guangdong Province on the Issuance of the Implementation Plan for Reforming and Improving Policies on the Supply and Use of Generic Medicines in Guangdong Province
粤府办〔2018〕47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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · 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 53592 · recorded trade USD 106,623,326

Implementing jurisdiction: China · intervention 53592

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 吉林省人民政府公报 2018-09-12 175 d
Guangdong this document 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

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 粤府办〔2018〕47号 各地级以上市人民政府,各县(市、区) 人民政府,省政府各部门、各直属机构: 《广东省改革完善仿制药供应保障及使用政策实施方案》已经省人民政府同意,现印发给你们,请认真组织实施。实施过程中遇到的问题,请径向省药监局反映。 广东省人民政府办公厅 2018年10月30日 广东省改革完善仿制药供应保障及使用 政策实施方案 为深入贯彻落实习近平新时代中国特色社会主义思想和党的十九大精神,贯彻落实党中央、国务院关于推进健康中国建设、深化医改的工作部署,促进我省仿制药研发,提升仿制药质量疗效,提高药品供应保障能力,推动医药产业实现高质量发展,根据《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),结合我省实际,制定本实施方案。 一、鼓励仿制药研发生产。 按照国家公布的鼓励仿制药品目录和药品供应保障信息,引导企业研发、注册和生产仿制药,指导企业做好注册现场核查等工作。以市场需求为导向,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。(省药监局、卫生健康委负责。排在第一位的为牵头单位,下同) 二、加强仿制药技术攻关。 将鼓励仿制药品目录内的重点化学药品、生物药品关键共性技术研究列入省级科技计划,积极推荐有关项目申报国家科技重大专项、国家重点研发计划医药类重点专项。健全产学研医用协同创新机制,建立仿制药质量和疗效一致性评价(以下简称一致性评价)产学研技术创新联盟,发挥企业创新主体作用和医疗机构、科研机构、高等院校科技支撑作用。积极支持企业、医疗机构、科研机构和高等院校依托仿制药和新药研究,申报工程技术研究中心、新型研发机构、技术创新中心、重点实验室、企业重点实验室、临床医学研究中心等国家和省级平台,符合条件的优先列入扶持计划。积极引进和消化吸收国内外仿制药先进技术成果。(省科技厅、工业和信息化厅、卫生健康委、药监局负责) 三、加强仿制药知识产权管理和保护。 加大知识产权保护力度,严格专利行政执法,完善重点药品企业知识产权保护直通车制度。实施高质量专利培育工程,推进药品专利高质量发展。培育发展知识产权交易运营平台及机构,促进药品专利交易流转。积极配合国家知识产权局实施药品专利强制许可制度。建立完善药品领域专利预警机制,组织开展药品领域专利预警和分析评议,降低仿制药企业专利侵权风险。(省市场监管局、药监局负责) 四、推动仿制药产业交流合作。 加强与“一带一路”沿线国家和香港、澳门的交流合作,加快药品研发、注册、上市销售的国际化步伐。支持我省仿制药企业开展国际和区域产能合作,共同建立研发平台,积极引进先进管理经验和关键工艺技术,鼓励境内外企业在我省建立研发中心和生产基地。(省商务厅、科技厅、药监局负责) 五、加快推进一致性评价工作。 省相关部门要细化落实鼓励企业开展一致性评价的政策措施,统筹利用现有财政专项资金,对开展一致性评价工作提供必要的经费支持。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。鼓励医疗机构优先承接本省药品的一致性评价工作。医疗机构要建立健全临床试验研究者职务提升、职称晋升及薪酬待遇分配激励机制,提高医务人员开展临床试验的积极性。(省药监局、教育厅、科技厅、工业和信息化厅、人力资源社会保障厅、卫生健康委负责) 六、加强仿制药质量监管。 加强仿制药生产环节监管,全面实施药品生产质量管理规范,强化对药品生产企业的处方工艺、药用原辅料等监督检查,有针对性地组织开展飞行检查,督促药品生产企业落实药品生产质量管理规范主体责任。加强流通环节监管,完善全省药品流通电子监管系统,推进精准监管、智慧监管。加强使用环节监管,严格执行医疗机构药品监督管理办法,严把购进、验收、储存、养护、调配及使用各环节质量关。建立覆盖药品全生命周期的质量管理和追溯制度。(省药监局、卫生健康委负责) 七、做好仿制药集中采购工作。 畅通省第三方药品电子交易平台、广州和深圳药品集中采购平台准入渠道,将国家实施专利强制许可的药品和通过一致性评价的仿制药,无条件纳入药品采购目录,在采购平台上对纳入《中国上市药品目录集》的仿制药予以标注,并说明其与原研药可相互替代,做好药品标注的日常更新和维护,鼓励医疗机构优先采购。对于新批准上市的仿制药,相关部门应及时编制公立医疗卫生机构药品采购编码。通过一致性评价的仿制药,在药品集中采购中享受与原研药同等待遇,实行同层次竞价。对于同品种药品通过一致性评价的生产企业达到3家以上的,在药品集中采购等方面不再选用未通过一致性评价的药品。(省医保局、卫生健康委、国资委、药监局负责) 八、促进仿制药替代使用。 药监、卫生健康、医保等部门要加强对《中国上市药品目录集》的宣传,推动医疗机构、医生使用通过一致性评价的药品。拓宽通过一致性评价的仿制药入市途径,允许患者凭处方自由选择在医疗机构或医保定点零售药店购药。鼓励医保定点零售药店做好通过一致性评价仿制药的供应保障。落实处方点评制度,规范药品按通用名开具处方行为,对开具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,要优先采购使用仿制药。(省卫生健康委、医保局、药监局负责) 九、加强药品价格监测预警。 药品价格预警工作实行分级负责制。省医保局在部分地级以上市设立若干药品价格监测直报点,重点监测反馈上涨幅度较大或价格持续上涨的原料药和辅料的情况;各地级以上市医保局负责本区域内的药品监测预警工作,当地发生药品价格异常波动情况,应及时开展应急监测调查,并向省医保局报告。依法严厉打击原料药和辅料价格垄断等违法违规行为,保证原料药和辅料正常供应。(省医保局、卫生健康委、药监局负责) 十、健全短缺药品供应保障机制。 落实医疗卫生机构短缺药品信息报告制度,及时了解临床供应需求。建立以儿童用药、基本药物及用于临床少发疾病的急救用药等为重点的短缺药品监测目录,提高监测工作精准度。建立我省短缺药品储备制度。推进短缺药品集中生产基地建设,鼓励企业生产市场价格低、利润薄、长期不生产或少量生产的短缺药品。加强部门联动,健全短缺药品监测预警和分级应对机制,加强供需对接和协商调剂,提升短缺药品供应保障能力,满足人民群众基本用药需求。(省卫生健康委、工业和信息化厅、财政厅、商务厅、国资委、医保局、药监局负责) 十一、发挥基本医疗保险激励作用。 加快按通用名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。根据国家规定调整基本医疗保险药品目录,及时将符合条件的药品纳入医保支付范围。医保目录内新批准上市的治疗慢性病和癌症等仿制药品,要及时纳入门诊特定病种用药范围,满足患者用药需求。及时更新医保管理信息系统,确保新批准上市的仿制药及时同等纳入医保支付范围。建立医保基金预拨付机制,促进医疗机构与药商及时结算药款。完善按病种分值付费办法,建立激励约束机制,鼓励医疗机构使用仿制药。(省医保局、卫生健康委负责) 十二、落实支持政策。 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,按规定减按15%的税率征收企业所得税。完善主要由市场形成药品价格的机制,做好与药品采购、医保支付等改革政策的衔接。坚持药品分类采购,突出药品临床价值,充分考虑药品成本,形成有升有降、科学合理的采购价格,调动企业提高药品质量的积极性。(省税务局、科技厅、医保局、药监局负责)