Drugs and medical devices concern every family. Since the reform of the drug and medical device review and approval system, the pharmaceutical industry has significantly enhanced the level of innovation. In recent years, China's R & D of drugs and medical devices what kind of trend, the next review resources to which areas, what policy arrangements for the development of high-end medical devices, what initiatives to protect the development and production of drugs for rare diseases?
The relevant person in charge of the State Drug Administration in the State Council Information Office on the 5th held a series of press conferences on the theme of "authoritative departments talk about the opening", one by one to respond to these concerns.
Innovative products to speed up the market
Jiao Hong, director of the State Drug Administration, said that in the first half of this year, China has 24 innovative drugs and 28 innovative medical devices approved for marketing. Over the years, the State Drug Administration has continued to deepen the reform of the review and approval system of drugs and medical devices to encourage innovation policy dividends continue to be released. From these years, the number of drug and medical device product review acceptance and approval, China's drug and medical device innovation has entered an explosive period.
She said that encouraging innovation is the core essence of the drug and medical device review and approval system reform. Through the priority review process, more than 100 drugs are approved for marketing each year. The State Drug Administration is gradually tilting its review resources to innovative drugs with clear efficacy, pediatric drugs, drugs for rare diseases and other related products that are in urgent clinical need. 66 pediatric drugs were approved for marketing in 2022, and 46 more pediatric drugs completed review in the first half of this year.
The State Drug Administration also issued the "Implementation Opinions on Promoting the Development of Chinese Medicine Inheritance and Innovation" to promote the establishment of a review technical standard system in line with the characteristics of Chinese medicine, and approved 31 new Chinese medicine drugs to help the development of Chinese medicine inheritance and innovation.
At the same time, the solid promotion of generic drug quality and efficacy consistency evaluation work, there are 615 varieties through the consistency evaluation.
High-end device review "separate queue"
Xu Jinghe, deputy director of the State Drug Administration, said that to speed up the shortcomings of China's high-end medical equipment, accelerate the key core technology research, breakthroughs in technology bottlenecks, to achieve independent control of high-end medical equipment. In recent years, the State Drug Administration has done three major areas of work:
-- strengthen the top-level design and promote departmental synergy. The State Drug Administration and multiple departments jointly issued the "14th Five-Year Plan" national drug safety and promote high-quality development, to clarify the principles, goals and tasks to promote the quality development of the medical device industry. With the Ministry of Industry and Information Technology, the National Health Commission and other departments jointly issued the "Fourteenth Five-Year Plan" medical equipment industry development plan and other documents to form a policy synergy. Take the lead in establishing artificial intelligence medical devices, medical biomaterials two technology innovation cooperation platform, accelerate the transformation of relevant scientific and technological achievements in the field of medical devices, with the relevant products to unveil the handsome and other work, focusing on the frontier of scientific and technological development, advance layout.
--Strengthen regulatory research and continuous innovation in approval initiatives. Around the technology and regulatory frontier to continue to develop new tools, new standards, new methods of medical device regulation, the establishment of technical review to the product development stage forward work mechanism, focusing on such as ECMO, particle therapy system, ventricular assist system and other high-end medical devices, advance intervention guidance, point by point to help promote China's high-end medical devices breakthrough.
-- Encourage innovative medical devices to market and promote the high-quality development of the industry. In recent years, the State Drug Administration has issued "Special Review Procedures for Innovative Medical Devices" and "Priority Approval Procedures for Medical Devices" with innovative medical devices as the main focus, so that innovative products and clinically urgent products can be "lined up separately and run fast". At present, 217 innovative high-end medical devices such as "brain pacemaker", carbon ion therapy system, proton therapy system, magnetic resonance imaging system, panoramic dynamic PET-CT, third-generation artificial heart, artificial blood vessels, etc. have been approved to be marketed, achieving a breakthrough in the domestic production of high-end medical devices and solving the problem of heavy dependence on imports of some products. The problem.
The number and speed of rare disease drugs on the market increased
Huang Guo, deputy director of the State Drug Administration, said that it is very difficult to develop drugs for rare diseases, but the market size is not large. However, specifically for each family and each patient, rare disease drugs are indispensable life-saving medicines. Every rare disease drug is worthy of full efforts.
In recent years, the State Drug Administration has taken the opportunity to deepen the reform of the drug review and approval system in an effort to speed up the launch of rare disease drugs and make them available to more patients with rare diseases, with two main initiatives.
On the one hand, policy dividends have been released to keep the R&D of drugs for rare diseases accelerating. Since 2018, the State Drug Administration has established a special channel to separately queue, encourage filing and accelerate the review of new drugs outside of China that are in urgent clinical need, including drugs for rare diseases, in the review and approval process. Currently, 23 new drugs for rare diseases have been approved for import and listing through the special channel. The review and approval time frame for new drugs for rare diseases is the shortest among all drug listing applications.
On the other hand, technical guidance is strengthened to allow companies to take fewer detours. In view of the extremely low incidence of rare diseases, the difficulty of drug research far exceeds the specificity of other common diseases, special policies are given to innovative drugs for rare diseases, and drug review agencies implement early intervention, research and review linkage, and full service for new drugs for rare diseases, and set up special review teams to follow up the innovative R&D of new drugs for rare diseases. Enterprises are allowed to submit research data on a rolling basis, and a seamless mechanism has been established in communication, verification and testing, comprehensive review and other key aspects. These practices have improved the quality and efficiency of new drug development for rare diseases.
Through comprehensive measures, the number and speed of drugs for rare diseases listed in China have been "doubly enhanced" in recent years. 68 imported and domestic drugs for rare diseases have been approved for listing in China since 2018. In the next step, the State Drug Administration will continue to pay attention to the demand for drugs for rare diseases, speed up the review and approval of drugs for rare diseases on the basis of ensuring safety, effectiveness and quality control, and make the best efforts to slow down the development of rare diseases and improve the quality of life for patients with rare diseases.
The relevant person in charge of the State Drug Administration in the State Council Information Office on the 5th held a series of press conferences on the theme of "authoritative departments talk about the opening", one by one to respond to these concerns.
Innovative products to speed up the market
Jiao Hong, director of the State Drug Administration, said that in the first half of this year, China has 24 innovative drugs and 28 innovative medical devices approved for marketing. Over the years, the State Drug Administration has continued to deepen the reform of the review and approval system of drugs and medical devices to encourage innovation policy dividends continue to be released. From these years, the number of drug and medical device product review acceptance and approval, China's drug and medical device innovation has entered an explosive period.
She said that encouraging innovation is the core essence of the drug and medical device review and approval system reform. Through the priority review process, more than 100 drugs are approved for marketing each year. The State Drug Administration is gradually tilting its review resources to innovative drugs with clear efficacy, pediatric drugs, drugs for rare diseases and other related products that are in urgent clinical need. 66 pediatric drugs were approved for marketing in 2022, and 46 more pediatric drugs completed review in the first half of this year.
The State Drug Administration also issued the "Implementation Opinions on Promoting the Development of Chinese Medicine Inheritance and Innovation" to promote the establishment of a review technical standard system in line with the characteristics of Chinese medicine, and approved 31 new Chinese medicine drugs to help the development of Chinese medicine inheritance and innovation.
At the same time, the solid promotion of generic drug quality and efficacy consistency evaluation work, there are 615 varieties through the consistency evaluation.
High-end device review "separate queue"
Xu Jinghe, deputy director of the State Drug Administration, said that to speed up the shortcomings of China's high-end medical equipment, accelerate the key core technology research, breakthroughs in technology bottlenecks, to achieve independent control of high-end medical equipment. In recent years, the State Drug Administration has done three major areas of work:
-- strengthen the top-level design and promote departmental synergy. The State Drug Administration and multiple departments jointly issued the "14th Five-Year Plan" national drug safety and promote high-quality development, to clarify the principles, goals and tasks to promote the quality development of the medical device industry. With the Ministry of Industry and Information Technology, the National Health Commission and other departments jointly issued the "Fourteenth Five-Year Plan" medical equipment industry development plan and other documents to form a policy synergy. Take the lead in establishing artificial intelligence medical devices, medical biomaterials two technology innovation cooperation platform, accelerate the transformation of relevant scientific and technological achievements in the field of medical devices, with the relevant products to unveil the handsome and other work, focusing on the frontier of scientific and technological development, advance layout.
--Strengthen regulatory research and continuous innovation in approval initiatives. Around the technology and regulatory frontier to continue to develop new tools, new standards, new methods of medical device regulation, the establishment of technical review to the product development stage forward work mechanism, focusing on such as ECMO, particle therapy system, ventricular assist system and other high-end medical devices, advance intervention guidance, point by point to help promote China's high-end medical devices breakthrough.
-- Encourage innovative medical devices to market and promote the high-quality development of the industry. In recent years, the State Drug Administration has issued "Special Review Procedures for Innovative Medical Devices" and "Priority Approval Procedures for Medical Devices" with innovative medical devices as the main focus, so that innovative products and clinically urgent products can be "lined up separately and run fast". At present, 217 innovative high-end medical devices such as "brain pacemaker", carbon ion therapy system, proton therapy system, magnetic resonance imaging system, panoramic dynamic PET-CT, third-generation artificial heart, artificial blood vessels, etc. have been approved to be marketed, achieving a breakthrough in the domestic production of high-end medical devices and solving the problem of heavy dependence on imports of some products. The problem.
The number and speed of rare disease drugs on the market increased
Huang Guo, deputy director of the State Drug Administration, said that it is very difficult to develop drugs for rare diseases, but the market size is not large. However, specifically for each family and each patient, rare disease drugs are indispensable life-saving medicines. Every rare disease drug is worthy of full efforts.
In recent years, the State Drug Administration has taken the opportunity to deepen the reform of the drug review and approval system in an effort to speed up the launch of rare disease drugs and make them available to more patients with rare diseases, with two main initiatives.
On the one hand, policy dividends have been released to keep the R&D of drugs for rare diseases accelerating. Since 2018, the State Drug Administration has established a special channel to separately queue, encourage filing and accelerate the review of new drugs outside of China that are in urgent clinical need, including drugs for rare diseases, in the review and approval process. Currently, 23 new drugs for rare diseases have been approved for import and listing through the special channel. The review and approval time frame for new drugs for rare diseases is the shortest among all drug listing applications.
On the other hand, technical guidance is strengthened to allow companies to take fewer detours. In view of the extremely low incidence of rare diseases, the difficulty of drug research far exceeds the specificity of other common diseases, special policies are given to innovative drugs for rare diseases, and drug review agencies implement early intervention, research and review linkage, and full service for new drugs for rare diseases, and set up special review teams to follow up the innovative R&D of new drugs for rare diseases. Enterprises are allowed to submit research data on a rolling basis, and a seamless mechanism has been established in communication, verification and testing, comprehensive review and other key aspects. These practices have improved the quality and efficiency of new drug development for rare diseases.
Through comprehensive measures, the number and speed of drugs for rare diseases listed in China have been "doubly enhanced" in recent years. 68 imported and domestic drugs for rare diseases have been approved for listing in China since 2018. In the next step, the State Drug Administration will continue to pay attention to the demand for drugs for rare diseases, speed up the review and approval of drugs for rare diseases on the basis of ensuring safety, effectiveness and quality control, and make the best efforts to slow down the development of rare diseases and improve the quality of life for patients with rare diseases.
