On January 26, the opinions on several special measures to relax market access for Shenzhen to build a leading demonstration zone of socialism with Chinese characteristics (hereinafter referred to as the opinions) was issued, which mentioned that four articles related to the medical field, including relaxing the market access restrictions of medicine and medical devices, piloting the sale of Internet prescription drugs, optimizing the approval and access services of human genetic resources Relax the qualification and business access restrictions of medical institutions.
Lu Hongzhou, President of Shenzhen Third People's Hospital, told China Business News: "the opinions covers six areas and contains 24 special measures to support Shenzhen's bold exploration and trial. In particular, it puts forward innovative market access mechanisms in the field of medicine and health, and supports the research and development of new medical products and technologies such as stem cell therapy, immunotherapy and gene therapy."
An expert in the field of cardiovascular medical devices told the first financial reporter: "the newly issued opinions is the first pilot in Shenzhen and is expected to cover the whole Dawan District in the future."
Innovation Medical Management Co.Ltd(002173) system first
In response to the provisions on relaxing the market access restrictions of medicine and medical devices, the opinions pointed out that it supports the promotion of real-world data application in the full life cycle clinical evaluation of local drugs and medical devices in Shenzhen, focusing on clinical evaluation in the fields of clinical urgent need, treatment of rare diseases, AI medical algorithm, precision medicine, traditional Chinese medicine and so on, Further accelerate the listing process of new products, and timely discover and control the use risks of listed products. Accelerate the commercialization and clinical application of AI medical algorithms.
Ma min, President of China surgical Siasun Robot&Automation Co.Ltd(300024) enterprise Tinavi Medical Technologies Co.Ltd(688277) , told the first financial reporter: "the latest policy issued by Shenzhen is consistent with the general tone of the country's increasing reform and opening up, and also consistent with the overall idea of Boao music city's pilot system. It is bound to accelerate the approval, registration and clinical promotion of medical device enterprises and benefit patients as soon as possible."
Ma min told the first financial reporter that the real-world data application of medical devices has been carried out in Boao. The advantage is that it can omit the process of clinical trials of innovative products, directly use them for patients, collect data in real-world use, and use them as evidence for subsequent registration and approval.
"The clinical trial of innovative products is the most time-consuming and cost-effective process before the whole medical device goes on the market. The real world refers to the direct diagnosis and treatment of patients in the areas where the first trial or real-world research is allowed as long as the relevant certification is obtained abroad, such as CE or FDA certification." "This opens up both clinical and commercial channels, enabling the industry to use the latest technology faster and speed up its popularization," Ma said
In response to the real-world data application "focusing on the clinical evaluation of AI medical algorithm and precision medicine" pointed out in the opinions, Ma min told the first financial reporter that this will benefit the medical Siasun Robot&Automation Co.Ltd(300024) industry and promote the implementation of smart medical solutions.
Boao Lecheng pilot area has previously completed a number of "China's first cases" including Siemens Medical machine assisted coronary intervention. In an interview with China business news, the relevant leaders of Lecheng Administration Bureau said: "Lecheng was founded to enable innovative drugs and devices to enter the Chinese market faster. In the past, this process was relatively long. Now we have made a breakthrough in the system, and the most advanced technology in the world has been able to test in Lecheng almost synchronously."
The latest policies issued by Shenzhen have also connected with Boao's pilot system. "Shenzhen's policy is very cutting-edge, and the opening of medical devices will be accelerated in the future." A person in charge of a multinational medical device company told the first financial reporter.
cell gene therapy has significant advantages
The Opinions also pointed out that the Internet prescription drug sales will be carried out on a pilot basis, and the Shenzhen Electronic Prescription center will be established. For the prescription drugs listed and sold in China, except for the drugs banned by the state on the Internet, other drugs are allowed to be sold on the Internet by relying on the electronic prescription center, which will not be approved separately. Explore the use of digital RMB for transaction settlement; Blockchain and quantum information technology are used to realize Wuxi Online Offline Communication Information Technology Co.Ltd(300959) linkage supervision, whole process tracing of drug flow and safe data storage.
Chen Hua, CEO of huiyitianxia of enterprise Internet hospital, told the first financial reporter: "Following Hainan, Shenzhen e-prescription center was established with the support of two ministries and commissions, laying a foundation for the efficient and safe implementation of Internet prescription drug sales nationwide. In particular, the further opening of key links such as medical insurance settlement and purchase of prescription drugs has played a great role in demonstrating and promoting the value upgrading of Internet medicine in the era of digital economy, and we are also actively implementing it Practice and continue to explore. "
The opinion also proposes to optimize the approval and access services of human genetic resources, explore the establishment of an approval and management platform for human genetic resources, support the research and development of new medical products and technologies such as stem cell therapy, immunotherapy and gene therapy, optimize the approval procedures for human genetic resources activities involving international cooperation in clinical experiments, and provide scientific research samples such as human tissue and blood entering and leaving the country Laboratory reagents shall be subject to risk classification and classification management. On the premise of ensuring biological safety, low-risk special items shall be provided with customs clearance convenience, and archives shall be registered in the links of use, flow direction and post use destruction.
Shenzhen is rich in gene and stem cell research resources and strength. "In terms of stem cell research, Shenzhen is a science and technology highland with a pool of talents. Many university and hospital teams have projects under way and have obvious advantages," Lu Hongzhou told China business news
Dr. Mao Mao Mao, CEO of Siqin medical, a cancer early screening start-up, told the first financial reporter: "In gene related projects, international cooperation often involves human samples and corresponding genetic data. As a high-tech enterprise, under the current policy, we think it will require a lot of human and material resources, so we don't do international cooperation involving cross-border samples at present. If the policy changes in the future, we will reassess it."
As one of the experts who participated in the review of the first version of genetic resources management measures in the 1990s, Mao Mao said that the system of risk classification and hierarchical management for scientific research samples still needs to be refined.
A researcher engaged in organoid research in a hospital in Shenzhen told the first financial reporter: "the field of cell therapy in Shenzhen has driven the development of the whole industrial chain including cell culture equipment, and the development of medical devices in Shenzhen also has advantages."
In addition, the Opinions also proposed to relax the qualification and business access restrictions of medical institutions, delegate the approval authority of Shenzhen to accept Hong Kong and Macao service providers to Shenzhen for medical treatment, and further optimize the practice license approval process of Hong Kong and Macao wholly-owned and joint venture medical institutions. Overseas medical technical backbones with excellent clinical experience or high peer recognition are encouraged to practice in depth according to regulations. Explore the establishment of a hospital evaluation and certification standard system in line with international standards. The designated medical institutions in Shenzhen are in need of advanced clinical and urgent need, drugs and clinical urgent needs listed in Hong Kong and Macao, and medical devices that have been purchased and used by public hospitals in Hong Kong and Macao, and have advanced clinical applications.
