New drugs that are not on the market are available here

On September 1, the General Office of the People's Government of Hainan Province officially issued the "Hainan Free Trade Port Boao Lecheng International Medical Tourism Advance Zone System Integrated Innovation Reform Program" (hereinafter referred to as the "Programme").
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 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 area 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 tourism pioneers in Boao Lecheng, Hainan Province, the world's newest and most technologically cutting-edge medical devices and medicines that are not yet available in China can be used in advance.
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 China's 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 incentives and protection for innovation, and improve access for patients with 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, and have irreplaceable value for the realization of the "Healthy China 2030" goal.
, 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.
new drugs approved for listing in China "Programme" 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 exceeded 100 for the first time, with 100 new anti-tumor drugs and rare disease drugs available.
Previously, the medium-severe plaque-like psoriasis drug Skuchiyu monoantitor, moderate-severe specialty dermatitis drug Dupixent, cervical cancer nine-price HPV vaccine and other innovative drugs, vaccines have been successfully introduced in the lead area of Lecheng, in advance to benefit users, and accumulated 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. The basic requirements put institutional integration innovation in a prominent position, with risk prevention and control as the bottom line, emancipate the mind, boldly innovate, use hainan free trade port reform initiative, in the comprehensive implementation of the "minimalist approval" reform, licensed drug trade free convenience, investment freedom and convenience, cross-border financial flows and strengthen risk prevention and other aspects to promote institutional integration innovation reform, enhance Hainan free trade port Boao Lecheng International Medical Tourism Pilot Zone (hereinafter referred to as Lecheng Advance Zone) medical and health management efficiency.
Ii, the main goal is to implement the overall requirements of the construction of Hainan Free Trade Port, promote the high-level open, high-quality development of the Lecheng Advance Zone, adhere to the concept of planning leadership, ecological priority, 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, benchmark the international advanced level, build a rule of law, internationalization and facilitation of the business environment, and provide replicable experience for the construction of Hainan Free Trade Port.
, reform measures (1) the free and convenient trade in licensed drugs.
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 non-meeting approval and access, patient follow-up, adverse reaction monitoring and other whole process 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 innovated the "first entry, then quarantine" supervision and quarantine model, greatly improving the efficiency of drug imports.
Encourage the 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, to achieve the transformation from "patients and other drugs" to "drugs and other patients."
3. The only "Never End International Innovative Drug Show" in China.
to provide online and offline display, release, training platform for international innovative drugs not listed in China, to achieve doctors, patients can enjoy the world's synchronization of innovative pharmaceutical services, 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 drugs, agents, 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 are not lowered, a window acceptance, one-time notification, all kinds of permits for a one-time processing, to achieve "the park is in charge."
regularly convene the Industry Common Governance Committee to promote the park's various affairs to build, co-rule and share.
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 the foreign exchange registration of pilot enterprises listed overseas directly to the bank; 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 policies and 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 medical 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, 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. To 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, the domestic unlisted drugs will be added to the 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.
Multiple breakthroughs in obtaining health insurance, including no age and occupation, no waiting period, no deductibles, no medical examination required for insurance, no restrictions on past medical history insurance, and exemption from the liability for medication of previous medical histories only when making claims.
the introduction of commercial insurance payment platform, for patients to provide insalinment payment and other options.
(vi) to carry out clinical real-world data application pilot, to promote the health care "minimal approval" reform.
10. The first clinical real-world data in China is used in the new model of drug registration.
Lecheng Advance District enjoys the country's unique policy of importing and using licensed drugs, and every clinical data generated by it is valuable while meeting the needs of patients for medical treatment.
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, exploring the clinical data of licensed drugs that will be used without China's registration and approval in the lecheng advance area, through 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 of global innovative drugs into 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 supervision 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.
The application unit or individual shall submit the application materials for registration of practice to the management agency of the park, and the administrative authority of the park shall submit the application materials to the approval office of the provincial health and health committee within 1 working day, and the approval and approval of the license for the registration of medical institutions and the configuration of large-scale medical equipment shall be issued.
13. The registration of medical practice is convenient.
standard-setting guidelines, through the electronic system for medical registration, greatly reduce the registration time limit, improve the efficiency of approval.
domestic health care registration within 1 working day to complete, foreign medical care note