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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

Implementation Opinions of the General Office of the People’s Government of Anhui Province on Reforming and Improving Policies on the Supply and Use of Generic Medicines
皖政办〔2018〕48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 · 86 relationships

Argentina: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · 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 70372 · recorded trade USD 106,623,326

Implementing jurisdiction: China · intervention 70372

Argentina: Trade-based inference; exporters to China; summed product trade > USD 1m; 2017 trade; broad sector headings; computed, not analyst-reviewed · intervention 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · 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 70373 · recorded trade USD 106,623,326

Implementing jurisdiction: China · intervention 70373

Assessment states
  • Trade-based partners recorded
  • Trade-based partners recorded

Measures

Capital grant
Provincial · origin: Chinese firms or production in China · locality: Local firms · CPC 352 · in force from 2018-01-01 · until 2020-12-31 · Keyword screen (unreviewed)
Implemented by China (subnational) · affects 42 partners (inferred from trade data, 2017 trade): Germany, United States, France, Italy, Switzerland, Sweden …
医药企业每取得1个全国第一家仿制(首仿)药品生产批件并落户我省生产的,一次性给予200万元奖励。
Supports production in a place, so favours that place by rule.
Tax relief
Provincial · origin: Chinese firms or production in China · locality: Local firms · CPC 352 · in force from 2018-01-01 · until 2020-12-31 · 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 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 this document 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.

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各市、县人民政府,省政府各部门、各直属机构: 为贯彻落实党的十九大精神和党中央、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,更好地满足临床用药及公共卫生安全需求,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),经省政府同意,现就改革完善我省仿制药供应保障及使用政策提出如下实施意见。 一、促进仿制药研发 (一)执行鼓励仿制的药品目录。按照国家统一部署,建立跨部门的药品生产和使用信息共享机制,强化药品供应保障及使用信息监测,及时掌握和发布药品供求情况,引导我省制药企业研发、注册和生产。实施国家鼓励仿制的药品目录,依托我省制药企业现有研发和生产能力,以需求为导向,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。(省药品监管部门、省卫生健康部门、省经济和信息化部门。列在第一位的为牵头部门,下同) (二)加强仿制药技术攻关。组织实施省科技重大专项、省重点研发等科技计划项目,围绕鼓励仿制药品目录内的重点化学药品、生物药品,开展关键共性技术研究。健全产学研医用协同创新机制,建立仿制药技术攻关联盟,发挥企业的主导作用和医院、科研机构、高等院校的基础支撑作用,鼓励支持企业加强药用原辅料、包装材料和制剂研发联动,促进药品研发链和产业链有机衔接。对我省仿制药项目获得国家重大科技专项并在省内实施的,可以直接纳入省重大新兴产业专项予以支持。(省科技部门、省发展改革部门、省财政部门、省教育部门、省经济和信息化部门、省人力资源社会保障部门、省药品监管部门) (三)完善药品知识产权保护。坚持鼓励新药创制和鼓励仿制药研发并重的原则,严格执行我国药品知识产权保护制度,充分平衡药品专利权人与社会公众的利益。加强知识产权领域反垄断执法,在充分保护药品创新的同时,防止知识产权滥用,制止滥用知识产权排除、限制竞争等行为,促进仿制药上市。建立完善药品领域专利预警机制,降低仿制药企业专利侵权风险。(省科技部门、省知识产权部门、省市场监管部门) 二、提升仿制药质量疗效 (四)加快推进仿制药质量和疗效一致性评价工作。相关部门要细化落实措施,形成政策合力,加快推进仿制药质量和疗效一致性评价工作。进一步释放仿制药一致性评价资源,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。鼓励符合条件的医疗机构、医学研究机构、医药高等学校等开展药品临床试验,将临床试验条件和能力评价纳入医疗机构等级评审。对已获得国家资格认定或获得备案并开展研究的我省药物临床试验机构(GCP)给予一次性100万元奖励。对临床使用量大、金额占比高的品种,有关部门要加快工作进度;对临床必需、价格低廉的品种,采取针对性措施,通过完善采购使用政策等方式给予支持。(省药品监管部门、省经济和信息化部门、省发展改革部门、省财政部门、省教育部门、省卫生健康部门、省科技部门、省人力资源社会保障部门) (五)提高药用材料质量和药品工艺制造水平。推动企业等加强药用原辅料和包装材料研发、创新,运用新材料、新工艺、新技术,提高质量水平。通过提高自我创新能力、积极引进国外先进技术等措施,推动技术升级,突破提纯、质量控制等关键技术,淘汰落后技术和产能,满足制剂质量需求。加强对药品药用原辅料和包装材料的质量监管,定期公布对生产厂家的检查和抽验信息。大力提升制药装备和智能制造水平,提高关键设备的研究制造能力和设备性能,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。鼓励生产企业建立自有仿制药品种处方工艺档案。(省经济和信息化部门、省科技部门、省药品监管部门、省卫生健康部门) (六)加强药品质量监管。督促仿制药企业严格执行药品生产质量管理规范(GMP),如实记录生产过程各项信息,确保数据真实、完整、准确、可追溯。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、擅自改变生产工艺、偷工减料、掺杂使假等违法违规行为,强化责任追究,检查和处罚结果及时向社会公开。(省药品监管部门、省卫生健康部门) 三、落实支持政策 (七)及时纳入采购目录。药品集中采购机构要按药品通用名编制采购目录,促进与原研药质量和疗效一致的仿制药和原研药平等竞争。对于新批准上市的仿制药,统一采用国家编制的公立医疗卫生机构药品采购编码,对应的通用名药品已在药品采购目录中的,药品集中采购机构应及时启动采购程序;对应的通用名药品未在药品采购目录中的,自批准上市之日起,药品集中采购机构要及时论证,积极将其纳入药品采购目录。国家实施专利强制许可的药品,无条件纳入我省药品采购目录。药品集中采购过程中,同品种药品通过一致性评价的生产企业达到3家及以上的,不再选用未通过一致性评价的品种;未达到3家的,优先采购和使用已通过一致性评价的品种。(省医疗保障部门、省卫生健康部门、省市场监管部门) (八)促进仿制药替代使用。制定鼓励使用仿制药的政策和激励措施,将通过质量和疗效一致性评价的仿制药,纳入与原研药可相互替代药品目录,在说明书、标签中予以标注,并及时向社会公布,便于医务人员和患者选择使用。卫生计生等部门要加强药事管理,组织开展临床用药综合评价工作,加大对临床用药的监管力度。严格落实按药品通用名开具处方的要求,除特殊情形外,处方上不得出现商品名。落实处方点评制度,加强医疗机构药品合理使用情况考核,对不合理用药的处方医生进行公示,并建立约谈制度。强化药师在处方审核和药品调配中的作用。在按规定向艾滋病、结核病患者提供药物时,优先采购使用仿制药。(省卫生健康部门) (九)发挥基本医疗保险的激励作用。健全完善药品医保支付参考价政策,通过质量和疗效一致性评价的仿制药与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,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,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。将仿制药替代使用情况作为医疗保险监管的重要内容,强化医保规范医疗行为和控制医药费用的作用,加强医疗机构考核监管,鼓励和推动医疗机构使用仿制药。(省医疗保障部门、省卫生健康部门) (十)落实税收优惠等政策。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。我省仿制药企业在2018年1月1日至2020年12月31日期间新购进的设备、器具(除房屋、建筑物以外的固定资产),单位价值不超过500万元的,允许一次性计入当期成本费用,在计算应纳税所得额时扣除。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。切实落实鼓励企业开展仿制药质量和疗效一致性评价的政策措施,对完成质量和疗效一致性评价的仿制药,每个品种给予一次性奖补100万元,单个企业最高可达300万元。医药企业每取得1个全国第一家仿制(首仿)药品生产批件并落户我省生产的,一次性给予200万元奖励。(省税务部门、省发展改革部门、省经济和信息化部门、省财政部门) (十一)落实药品价格政策。持续推进药品价格改革,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。加强鼓励仿制的药品目录内的重点药品市场价格监测预警,促进药品市场价格信息透明,依法严厉打击垄断原料药价格、虚报原材料价格和药品出厂价格等违法违规行为。(省医疗保障部门、省药品监管部门、省卫生健康部门) (十二)推动仿制药产业转型升级和国际化。相关部门要加大扶持力度,出台支持我省仿制药产业转型升级政策,支持仿制药企业工艺改造。对首次进入全国医药行业百强的我省企业,给予一次性奖补200万元。对我省医药生产企业单个品种年销售收入首次突破1亿元、5亿元、8亿元、10亿元的,每上一个台阶给予企业100万元奖励。对获得欧洲药品质量管理局EDQM认证、美国食品药品管理局FDA认证、世界卫生组织PQ认证的我省医药企业,一次性给予100万元奖励。结合推进“一带一路”建设重大倡议,鼓励支持我省制药企业开展国际科技合作和交流。积极引进先进管理经验和关键工艺技术,鼓励境内外大型制药企业在我省建立研发中心和生产基地。对总部新落户我省的全国医药行业百强企业,给予一次性奖补200万元。对医药企业产品取得国际注册批件并落户我省生产的,每获取1个产品的国际注册批件给予50万元奖励。(省经济和信息化部门、省发展改革部门、省财政部门、省药品监管部门、省科技部门、省商务部门) (十三)做好宣传引导。相关部门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。加强对医务人员的宣传教育,改变不合理用药习惯,提高合理用药水平,推动仿制药替代使用。及时回应社会关切,合理引导社会舆论和群众预期,形成良好改革氛围。(省卫生健康部门、省医疗保障部门、省药品监管部门) 安徽省人民政府办公厅 2018年11月21日