New drugs that are not on the market are available here.

The Program proposes to comprehensively implement the reform of "minimal approval", the free and convenient trade in licensed pharmaceuticals, the freedom of investment, the convenience of cross-border financial flows and the strengthening of risk prevention, and other aspects to promote institutional integration and innovation reform, to create a number of "unique", to achieve medical technology, equipment, medicine and international advanced level "three synchronization", to build a world-class international medical tourism destination and medical science and technology innovation platform, the international advanced level.
Unlisted innovative drugs, can be used according to the Program, Hainan Boao Lecheng Medical Tourism Advance Zone will create the only domestic unlisted licensed drugs full process traceability platform;
, will rely on Boao Super Hospital and other park medical institutions, the introduction of international innovative drug conversion platform, the system to accelerate the introduction of global innovative drugs, agents, investment, use, registration and so on.
medical devices and medicines that are the world's newest and most technologically cutting-edge but not yet available in China can be used in advance in the medical tourism pioneer area of Boao Lecheng, Hainan Province.
It is understood that on April 10, this year, the "Never End" International Innovative Drug Exhibition opened in the medical tourism advance area of Boao Lecheng, Hainan, the exhibition attracted 25 multinational enterprises, more than 300 kinds of drug varieties not listed in China on display, causing widespread concern in the industry.
In the past five years, China has taken a number of measures to encourage pharmaceutical innovation, optimize the drug review and approval process, so that the introduction of innovative drugs into the fast lane, but compared with developed countries, China's drug use structure still has room for optimization and improvement.
analysis data show that china's overall drug market size, innovative drugs only 25%, with the global average of 60% and 80% of developed countries in Europe and the United States, the proportion of innovative drugs is still a big gap.
A study by the Pharmaceutical Research and Development Industry Committee of the China Association of Foreign Investment Enterprises shows that between January 2009 and June 2019, half of the new drugs approved daily in Europe and the United States failed to enter China, of which 71% met China's urgent clinical needs.
, it is particularly urgent to continue to accelerate the introduction of innovative drugs, strengthen the incentives and protection of innovation, and improve the access of patients of innovative drugs.
We all know that for patients, families and social development, innovative drugs can not only help treatment to prolong life and improve the quality of life of patients, but also save overall medical costs, promote economic development, for the "Healthy China 2030" goal has irreplaceable value.
, Hainan Boao Lecheng International Medical Tourism Zone is committed to the introduction of innovative drugs, for the development of China's medical industry is of great significance.
"Programme" to help new drugs approved for listing in China proposed to carry out clinical real-world data application pilot, to promote the health care "minimal approval" reform.
the first clinical real-world data in China for the new model of drug registration.
through scientific research design, strict data collection, efficient information processing, correct statistical analysis, multi-dimensional results evaluation, into real-world evidence, for registration and approval in China.
According to Li Lijing, executive deputy director of the Medical and Drug Administration of Lecheng Advance District, as of June this year, Lecheng Advance District imported licensed drug varieties for the first time exceeded 100 cases, can use new anti-tumor drugs, rare disease drugs up to 100 kinds.
Previously, innovative drugs such as the moderate-severe plaque-like psoriasis drug Skuchium, the medium-severe specialty dermatitis drug Dupixent, and the nine-price HPV vaccine for cervical cancer were successfully introduced in the lecheng advance area, benefiting users in advance and accumulating clinical experience.
Clinical real-world data application pilot, can shorten the global innovative drugs into the Chinese market time, reduce the cost of registration, so that many international innovative pharmaceutical enterprises more actively promote innovative drugs into China, benefit the vast number of patients, but also for the national drug medical device review and approval system reform, speed up the global innovative drugs in China's clinical use of access, providing a new solution.
In the drug review and approval, patient access and other links, Lecheng first district implemented innovative initiatives, so that domestic patients can be used in a timely manner, affordable life-saving drugs, enjoy the dividends of global pharmaceutical innovation.
Attached: Hainan Free Trade Port Boao Lecheng International Medical Tourism Advance Zone System Integrated Innovation Reform Program For the implementation of General Secretary Xi Jinping's "April 13" important speech, document No. 12 of the Central Committee and General Secretary Xi Jinping's important instructions on the construction of Hainan Free Trade Port, according to the "Hainan Free Trade Port" The National Development and Reform Commission, the National Health and Health Commission, the State Administration of Traditional Chinese Medicine, the State Drug Administration on support for the construction of Boao Lecheng International Medical Tourism Advance Zone Implementation Program, Hainan Free Trade Port Boao LeCheng International Medical Tourism Advance Zone Regulations and other documents spirit, specially formulated this program.
I. Basic requirements Put system integration innovation in a prominent position, take risk prevention and control as the bottom line, emancipate the mind, boldly innovate, use the initiative of Hainan Free Trade Port reform, promote system integration innovation reform in the comprehensive implementation of the "minimal approval" reform, free and convenient licensing of pharmaceutical trade, free investment convenience, cross-border financial flow facilitation and strengthening risk prevention, and enhance the medical and health management efficiency of the Hainan Free Trade Port Boao Lecheng International Medical Tourism Advance Zone (hereinafter referred to as Lecheng Advance Zone)
2. The main objectives are to implement the overall requirements of the construction of Hainan Free Trade Port, promote the high-level open and high-quality development of the Lecheng Advance Zone, adhere to the concept of planning leadership, ecological priority and green development, realize the "three synchronizations" of medical technology, equipment, medicine and international advanced level, build a world-class international medical tourism destination and medical science and technology innovation platform, and build a legalized, internationalized and convenient business environment for the construction of Hainan Free Trade Port.
, reform measures (1) the free and convenient trade in licensed medicines.
1. Create the only domestic unlisted licensed drug full process traceability platform.
Lecheng Advance District Administration, Provincial Drug Administration, Provincial Health And Health Commission, Haikou Customs and other departments to use blockchain, Internet of Things, 3D GIS (GEOGRAPHIC) and BIM (building information model) and other new generation of information technology, to build a public demand-oriented, data sharing-based, Business synergy as the focus, unified and convenient as the standard, real-time supervision as the necessary full process traceability platform for licensed drugs, energy park intelligent supervision, and high standards of international trade "single window" organic convergence, foreign listed domestic clinical urgent need for licensed drugs approval time reduced to 3 working days (see annex 1).
The realization of the whole process of non-meeting approval and admission, patient follow-up, adverse reaction monitoring and other traceable supervision, for the licensed drug "can handle, put open" to provide a practical grasp, the formation of a physical fence-free special supervision, the initial realization of international innovative drugs, medical devices in sync with the use.
2. Establish the only unlisted innovative drugs centralized storage bonded warehouse.
Haikou Customs innovation to implement the "first warehouse, then quarantine" supervision and quarantine model, greatly improve the efficiency of drug imports.
Encourage bulk import storage of pharmaceutical equipment, explore the bonded warehouse "distribution collection report" out of the warehouse mode, increase the public properties of bonded warehouse, support bonded warehouse to provide logistics, customs, transportation, warehousing, distribution and other services, greatly reduce drug clearance, logistics, storage costs, from "patients and other drugs" to "drugs and other patients" transformation.
3. Held the only domestic "never end the international innovative drug exhibition."
for the international innovative drugs not listed in China to provide online and offline display, release, training platform, to achieve doctors, patients can enjoy the world without going abroad to enjoy innovative pharmaceutical services synchronized with the world, to create a new international innovative drugs China display window.
(ii) the freedom and convenience of investment.
4. Build a platform for medical innovation and entrepreneurship.
Relying on Boao Super Hospital and other park medical institutions, the introduction of international innovative drug conversion platform, the system accelerates the introduction of global innovative pharmaceutical equipment, agent, investment, use, registration, etc. ;
5. Innovative service model.
the establishment of the Lecheng Authority-based, multi-sectoral coordination of the joint evaluation mechanism to ensure that the project entry standards do not lower, a window acceptance, one-time notification, all kinds of permits for one-time processing, to achieve "the park is in charge."
regularly convene industry co-governance committees to promote the joint construction, co-management and sharing of all matters in the park.
set up a chartered medical regional ethics center to share all kinds of professionals, unified for the use of innovative drugs to control the risks.
(iii) free and convenient cross-border financial flows.
6. Take the lead in the liberalization and facilitation of cross-border financial flows in Hainan Free Trade Port.
Further promote the settlement and facilitation of cross-border transactions in medical, pharmaceutical and medical devices, realize the pre-examination of bank authenticity and turn it into post-verification, promote the development of medical, pharmaceutical, equipment and health care services and other industries, simplify exchange management in overseas listing, issuance of bonds, etc., take the lead in pilot enterprises to register foreign exchange listed overseas directly to banks; Enterprise capital use scope, actively introduce the "regulatory sandbox" mechanism, take the lead in the pilot innovation of artificial intelligence, big data, cloud computing and other technology and financial policies, products and tools, set up financial services centers, coordinate relevant industry authorities and financial institutions for resident enterprises and projects to provide cross-border financial flows services, co-ordinate the promotion of commercial medical insurance services linked to the international commercial insurance payment system and cooperation in the development of cross-border medical insurance products.
(4) Foreign personnel to stop, residence facilitation.
7. Strengthen the implementation of existing policy measures to facilitate the introduction of wisdom.
mainly includes more convenient entry and suspension and residence measures for foreign high-level talents, residence facilities for the employment of foreign skilled personnel, facilities for the employment and entrepreneurship of foreign students in universities, and permanent residence facilities for foreigners who work and invest.
8. Measures to facilitate the entry and stay of foreign medical personnel, patients and escorts.
Medical and health care personnel working in the park may apply for a work-type residence permit consistent with the work contract, foreigners and their accompanying family members may apply for a private affairs visa or residence permit consistent with the duration of medical services, and set up a patient service center to provide one-stop services such as consultation, diagnosis and treatment for domestic and foreign patients to facilitate the diagnosis and treatment of domestic and foreign patients and optimize the development environment of the park.
(v) to create the only domestic "global special medicine insurance", innovative pharmaceutical insurance payment methods.
9. Build an integrated insurance service platform to support all insurance institutions to implement various types of insurance product innovation at all levels.
the first time that unlisted drugs in China will be added to domestic health insurance through the "Medicare plus Commercial Insurance" mechanism.
Make full use of multiple precision pricing factors such as the occurrence rate of sub-site tumors, estimates of the cost of special drugs for different tumors in the drug catalogue within different guaranteed time, compensation or discount of drug costs, and reconstruct the traditional pricing model of commercial health insurance based on the occurrence rate of diseases to solve the problem of high prices of special drugs abroad.
Several breakthroughs in obtaining health insurance, including no age and occupation, no waiting period, no deductibles, no medical examination at the time of insurance, no restrictions on past medical history insurance, and exemption from liability for drug use in the past medical history only when making claims.
the introduction of commercial insurance payment platform, for patients to provide insalinment payment and other programs.
(vi) to carry out clinical real-world data application pilot, to promote the health care "minimal approval" reform.
10. China's first clinical real-world data for drug registration of new models.
City Advance District enjoys the country's unique policy of import and use of licensed drugs, in order to meet the needs of patients for medical treatment at the same time, the resulting clinical data are valuable.
Provincial Drug Administration, under the guidance of the State Drug Administration, using the licensed drug policy, carried out clinical real-world data application pilot work, explored the clinical data of licensed drug used in the lecheng advance area without Chinese registration and approval, after scientific research and design, strict data collection, efficient information processing, correct statistical analysis, multi-dimensional results evaluation, into real-world evidence for registration and approval in China.
Clinical real-world data application pilot can shorten the time for global innovative drugs to enter the Chinese market, reduce the cost of registration, so that many international innovative pharmaceutical enterprises more actively promote innovative drugs into China, benefit the vast number of patients, but also for the national drug medical device review and approval system reform, speed up the global innovative drugs in China's clinical use of access, providing a new solution.
11. Innovative model of institutional regulation of medicines and pharmaceuticals.
To create the first medical drug regulatory agency jointly established by the health department and the drug regulatory department, innovate and implement the integrated supervision mode of "health and medicine", realize one-stop office, improve the efficiency of licensing drug approval, make the government perform its functions more smoothly, realize business coordination, information exchange, resource sharing, avoid long-term supervision, form a regulatory force, reduce administrative costs and improve regulatory efficiency.
12. Implementation of the "two certificates, one batch of the same issue" system.
For medical institutions established in the first district of Lecheng, no longer issue the "Approval for the Establishment of Medical Institutions", only issue "Medical Institutions Practice License", and apply for the equipment of Class A large-scale medical equipment, can be approved and approved, greatly shorten the preparation cycle of medical institutions, reduce the pre-operational costs of medical institutions.
By the applicant unit or individual to the park management agency to submit the application for registration of practice, the park management agency within 1 working day to the provincial health and health committee approval office, the provincial health and health committee approval office within 1 working day to review the materials, and issued medical institutions license for registration of practice and large-scale medical equipment configuration license approval.
13. The registration of medical practice is convenient.
standard guidelines, through the electronic system for medical registration, greatly reduce the registration time limit, improve the efficiency of approval.
within 1 working day of registration of domestic medical care and 5 working days of registration of foreign medical care.
14. Medical institutions in the park to achieve.