医疗政策 Pharmaceutical Policies

医疗政策合集

（一）海南省/自贸港政策

1.支持与境外机构合作开发跨境医疗保险产品;

2.建设区域医疗中心;

3.优先支持企业境外上市。企业境外上市外汇登记直接到银行办理;

4.立足自由贸易港建设实际制定法规;

5.临床前研究。在研创新药（含生物制品，下同）、改良型新药、生物类似药和获批纳入国家医疗器械创新或优先审批通道的第三类医疗器械获得临床批件后，按品种给予产品注册申请人最高200万元的一次性奖励;

6.临床试验。在研创新药、改良型新药和生物类似药完成I期、II期、Ⅲ期临床试验研究后，分阶段给予产品注册申请人总额1000万元的临床试验补助。获批纳入国家医疗器械创新或优先审批通道的第三类医疗器械完成临床试验研究后，给予产品注册申请人300万元的一次性补助;其他第三类医疗器械完成临床试验研究后给予产品注册申请人100万元的一次性补助;

7.新成果产业化。获得药品批准文号并在本省产业化，按药品批准文号类别和数量给予药品上市许可持有人一次性奖励最高600万。获得医疗器械注册批文并在本省产业化，给予产品上市许可持有人一次性奖励最高高200万;

8.新产品引进。对新引进落地至海南，委托外地生产，但在海南结算的品种，按照每个批文50万元的标准给予产品上市许可持有人补贴;

9.仿制药质量和疗效一致性评价。对通过一致性评价的化学仿制药，按每个品种200万元的标准给予药品上市许可持有人一次性补助;对于全国前3位通过的品种，再一次性给予100万元奖励;

10.新产品做大做强。对2019年以来在本省新上市的产品根据年销售情况对上市许可持有人给予50-200万奖励;

11.产品质量标准再提升。对于达到美国、欧盟和日本等主流市场认证标准并在当地首次完成产品注册落户本省生产的给予一次性最高50万奖励；

Pharmaceutical Policies

01 Policies of Hainan Province/Fress Trade Port

● Support will be provided to enterprises working with overseas institutions in developing cross-border medical insurance products;

● A regional medical center will be built;

● Priority will be given to supporting enterprises overseas listing. The foreign exchange registration of overseas-listed enterprises can be handled directly by banks;

● Laws and regulations should be formulated based on the development reality of the free trade port;

● Pre-clinical studies. After clinical trial approval is granted to innovative drugs (including biological products, the same hereinafter),modified new drugs and biosimilars in the R&D pipeline, and Class Ⅲmedical devices approved for Special Review for Innovative Medical Devices or Priority Review for Medical Devices,product registration applicants will be given a one-off reward up to RMB 2 million depending on the variety;

● Clinical trials. After the completion of Phase I, Phase II, and Phase Ill clinical trials of innovative drugs, modified new drugs and biosimilars in the R&D pipeline, a clinical trial subsidy totaling RMB 10 million will be given to product registration applicants in phases. After Class Ⅲ medical devices approved for Special Review for Innovative Medical Devices or Priority Review for Medical Devices complete clinical trials, a one-off subsidy of RMB 3 million will be given to the product registration applicant;after other Class II medical devices complete clinical trials, a one-off subsidy of RMB 1 million will be granted to the product registration applicant;

● Industrialization of new R&D outcomes. After obtaining the drug approval number and industrializing the drug in Hainan Province, the Marketing Authorization Holder will be given a one-off reward up to RMB 6 million depending on the type and digits of the drug approval number. After obtaining the medical device registration approval and industrializing the device in Hainan Province, the Marketing Authorization Holder will be given a one-off reward up to RMB 2 million;

● Introduction of new products. For products that are newly introduced into Hainan with production entrusted to other places outside Hainan and settlement in Hainan, a subsidy will be given to the product Marketing Authorization Holder, which stands at RMB 500,000 per approval;

● Quality and efficacy consistency evaluation of generic drugs. For chemical generic drugs that pass the consistency evaluation, a one-off subsidy of RMB 2 million per variety will be given to the Marketing Authorization Holder; for the first three generic drugs that are approved for a variety nationwide, an additional one-off reward of RMB 1 million will be given;

● Sales-based rewards for new products. For products that are newly marketed in Hainan starting from 2019, a reward in the range of RMB 500,000 to 2 million will be given to the Marketing Authorization Holder based on the annual sales;

● Rewards for meeting higher quality standard. For products that meet the certification standard of a mainstream market like the US, the European Union and Japan, have completed registration therein for the first time and are produced in Hainan, a one-off reward up to RMB 500,000 will be given;