Shanghai Economic New Deal released | Medical and health industry is open to comparison with Hainan

Medical Network July 12th Foreign anti-cancer drugs are used first, improve the efficiency of drug equipment clearance... Shanghai announced the opening and opening of 100, the drug medical equipment import hub port can be expected in the future.

Exploring the establishment of a medical visa system in China, the use of new anti-cancer drugs abroad, the promotion of the reform of the medical device registrant system to the city, improving the efficiency of drug equipment clearance, and the removal of the approval of the establishment of large-scale medical equipment for social medical institutions.

On July 10th, the “Shanghai Municipality Implements the National Plan for Further Enlarging and Opening Up to Accelerate the Establishment of a New System of Open Economy”, referred to as 'Shanghai Expands 100 Articles', and will promote the construction of drug medical equipment import hub ports. Go to the end.

The Hainan Free Trade Zone, which is accelerating construction, clearly gives Shanghai a first-hand experience. As we all know, since 2013, China has established 11 free trade pilot zones across the country, and Shanghai has been used as a pilot for cross-border capital and free flow of investment. Shanghai. Shanghai is also a city with relatively high quality medical resources. hospital The number is second only to Beijing, ranking second in the country. In the '100 open and open in Shanghai', medical care has received much attention. Among them, there are 8 policies on medical treatment, which directly refers to the new round of comprehensive opening of new medical and medical equipment imports. Highlands. In the openness of the medical and health industry, Shanghai seems to be 'one higher' than Hainan.

'Shanghai Expands 100 Articles' Article 85: To fight for the urgent need for clinically available overseas anti-tumor drugs that have been listed in China and have not been approved for registration in China, are used in Shanghai.

Article 86: For medical equipment that is undergoing clinical trials, for the treatment of serious life-threatening products that are not approved for registration in China, strive to develop in Shanghai.

Article 82: Exploring the establishment of a medical visa system in China.

It is understood that, according to the relevant laws and regulations of China, overseas listed drugs need to be re-tested in China, and it is often time-consuming in the clinical trial phase and the drug review and approval process. Even some drugs that are listed in the domestic market are outdated. Happening.

The implementation of Article 85 means that for patients with advanced cancer who have no more alternative treatments under the existing medical treatment regulations, the designated medical institutions in Shanghai can be used exploratoryly by the United States, the European Union, Drug regulatory agencies in Japan and other countries and regions have approved the listing, but there are no foreign anti-tumor drugs approved in China for the same variety of products.

The reduction of the approval process will make the living space of illegal overseas purchasing drugs smaller and smaller. Chen Yishui, deputy director of the Shanghai Food and Drug Administration, said in an interview with Xinhua News Agency: 'We hope to form a relatively reasonable price, which will make the company more motivated. It also ensures sustainability and uses life-saving drugs as soon as possible within a legal framework.

It is reported that the initial pilot program is clear, with the medical institution as the main body of the application, the Shanghai Food and Drug Administration, the joint health department, the comprehensive hospital energy level, medical services, quality management level and clinical experience, etc. General hospitals and subject rankings in the forefront of the country as designated pilot units.

In terms of the openness to imported drugs, Hainan has already been at the forefront of the country. In April 2018, the State Council issued a document, and imported medical devices that were not approved for registration in China can be used first in Hainan. According to Article 86, Nowadays, Shanghai has joined the ranks. This move is undoubtedly a good thing for the middle-aged patients. This saves the steps of re-clinical trials of medical devices in China, and the time of this step is often calculated as 'year'.

In recent years, global medical tourism appeals have been bullish. According to reports, China's medical tourism industry has soared to less than $10 billion in 2000, and has soared to $700 billion in 2017, and has maintained growth at a rate of 20% per year. Became one of the fastest growing emerging industries in the world. 'Shanghai Expands 100 Articles' Article 82 shows that it is necessary to explore the establishment of a medical visa system in China. This article also seems to be 'aligning' with the medical tourism industry in Hainan. In fact, compared Hainan, Shanghai has better medical resources and a more mature medical system. If the visa system can be convenient, I believe this will also make the hospitality of patients from neighboring countries more attractive.

'Shanghai Expands 100 Articles' Article 88: Cancel the approval of the establishment of large-scale medical equipment for the social medical institutions, and try to record the system.

In June 2018, the State Health and Health Commission issued the "Management Measures for the Configuration and Use of Large-scale Medical Equipment" to standardize and strengthen the management of the allocation and use of large-scale medical equipment. The regulations stipulate that if applying for the allocation of large-scale medical equipment of Class B, the local provincial health administration The department filed an application. Article 88 of 'Expanding and Opening 100 Articles in Shanghai' proposed to abolish the approval of the establishment of large-scale medical equipment for medical institutions in the social office, and trial and record the system. The New Deal will undoubtedly bring benefits to the development of social medical treatment.

In addition, the Shanghai Municipal Committee's comprehensive deepening reform leading group recently reviewed and approved the “Several Opinions of Shanghai on Accelerating the Development of Health Service Industry”. According to this document, Shanghai will allow public hospitals to cooperate with social forces to organize new non-profits according to planning and needs. Sexual medical institutions. Encourage public hospitals and social medical institutions to establish agreements and cooperation in talents, management, technology, etc., and encourage social doctors to participate in the construction of medical complexes. This is undoubtedly a major positive news for social medical practitioners. .

Article 87 of 'Shanghai Expands 100 Articles': Promote the reform of the medical device registrant system to the whole city, and gradually replicate and promote it to the Yangtze River Delta region.

Article 89: Efforts will be made to promote the construction of key laboratories at the national level of Shanghai Pharmaceutical Medical Device Inspection and Testing Organization, and achieve international recognition of test results.

Article 90: Support the promotion of flexible entry management modes such as 'one entry, batch clearance', and improve the efficiency of drug medical equipment clearance; medicine Supply chain platform.

Article 80: Simplify the import procedures for sample, equipment, reagents, etc. for research and development of qualified foreign-invested R&D centers; and develop drugs for qualified biomedical service outsourcing enterprises, medical instruments Sample import, the customs clearance time is shortened to 15 days.

In the past, Chinese medical devices implemented a model of product registration and production license 'bundling', which affected researchers and enterprise The enthusiasm for innovative R&D and continuous improvement of product quality limits the rational allocation of innovation elements and is inconsistent with international rules.

In December 2017, Shanghai piloted the medical device registrant system as a breakthrough in the major review and approval of the national medical device regulatory system. The medical device registrant system directly hit the long-term 'pain point' of enterprise development.

The implementation of Article 87 of 'Expanding 100 in Shanghai' will promote the system to the whole city and gradually replicate it to the Yangtze River Delta region. For the R&D and commissioned production of foundry enterprises, expanding the scope of the pilot will undoubtedly make the company participate in the enthusiasm. Further improvement, the pilot type will continue to be enriched. At the same time, this will further promote the division of labor and cooperation among medical device companies, and form a cluster effect of each district, and the effect of resource optimization will become more apparent.

Articles 90 and 80 both indicate that a number of measures will be taken to improve the efficiency of drug medical device clearance. Especially for foreign R&D centers and biomedical service outsourcing enterprises, the import procedures for drugs and equipment will be simplified, and the customs clearance time will be shortened. .

These policies are all indicative of Shanghai's determination to build a hub for the import of pharmaceutical medical devices.

In addition, 32 of the “Opening 100 Articles in Shanghai” involve expansion and opening up in the financial sector, including 8 initiatives involving the insurance industry. As we all know, commercial insurance is essential for the support of high-end medical care, and often is a bundled relationship. As a financial center in China, the expansion of the Shanghai insurance industry will also have a positive impact on the health care industry.

The same as the free trade zone, Shanghai's GDP in 2017 is about 6.7 times that of Hainan Province, and the resident population is 2.6 times that of Hainan Province. If you enjoy the same open policy, Shanghai may have more development in the health care industry. Advantage.

Whether it is Shanghai, the international metropolis seeking transformation, or the Hainan Special Economic Zone, which seeks to leapfrog development, it will reveal the truth before the scale of value medical care: Who can take the lead in opening up a trial channel for clinically urgent patients with new drugs abroad, who can take patients Develop a zone for the center drug Admission policy, who can be at the forefront in the interregional reform competition.