Multi-pronged measures, the "quantity" and "quality" of children's medicines have increased
Over 600 million yuan has been invested, and 23 pediatric units have established a clinical trial collaboration network...
◎Our reporter Li He
In 2021, a total of 47 children's medicines were approved for marketing across the country, 14 of which were included in the priority review and approval process, which promoted the marketing process of children's medicines and significantly improved the level of children's clinical medicines.
At present, there are still more children's medicines in the application process, and the problem of children's medicines in my country will be further improved.
The new version of the National Medical Insurance Drug Catalog will be officially implemented on March 1, 2023.
The total number of drugs in the adjusted national medical insurance drug catalog has reached 2,967, and the newly added drugs cover 22 children's drugs.
Children's bodies are still in the growth and development stage, and their organs are not fully developed. Their liver and kidney functions are significantly different from those of adults in their ability to metabolize drugs and tolerance to adverse reactions.
Pediatric drugs refer to a class of drugs suitable for the special constitution and needs of minors under the age of 14.
The "Notice on Further Strengthening the Administration of Children's Clinical Drugs" (hereinafter referred to as the "Notice") recently issued by the National Health and Medical Commission proposes that when selecting children's medicines (limited to medicines with clear children's indications and children's usage and dosage in the drug instructions), , can further expand the scope of children's medication without being restricted by "one product, two regulations" and the total number of drugs.
The "Notice" also pointed out that medical institutions should accurately allocate children's medicines according to the prescribed dosage, especially for young children, encourage the development of new technologies and new methods that can flexibly adjust dosages, and strengthen standardized management and quality control of personalized medicine. , to reduce the inaccurate and unsafe problems caused by "guessing the dosage and breaking the medicine".
my country's children's drug research starts late and has a weak foundation
According to the main data of the seventh national census released in 2021, the population of children aged 0-14 in my country is 253.38 million, accounting for about 17.95% of the total population of my country.
The "2021 China Health Statistical Yearbook" shows that in 2020, the number of pediatric outpatient visits in general hospitals in my country will be 230 million.
Although the proportion of the population is not small and there are many children patients, compared with adult drugs, children's drug research still faces the dilemma of late start, great difficulty and weak foundation.
At present, there are few types of medicines for children in my country.
Chen Ruijie, director of the Pharmacy Department of the Second Affiliated Hospital of Wenzhou Medical University and Yuying Children's Hospital, said that children's medicines in my country mainly focus on respiratory and digestive system medicines.
Moreover, granules, tablets, and oral solutions are the main ones, while inhalants, chewing agents, patches, etc. are more suitable for children.
The data shows that in my country's children's drug market, the market shares of respiratory system drugs, digestive system drugs, anti-infective drugs and nutritional supplements are 39.2%, 20.5%, 17.6% and 15.8%, respectively. Tumor diseases, cardiovascular diseases, nervous system diseases Waiting for special drugs is less.
Introduce policies to improve the level of children's drug protection
Since 2011, my country has successively issued a number of favorable policies to encourage and support the R&D and production of children's medicines.
The newly revised "Drug Administration Law of the People's Republic of China" in 2019 clearly supports the development of new varieties, dosage forms and specifications of children's medicines that meet the physiological characteristics of children, and gives priority to the review and approval of children's medicines.
The State Food and Drug Administration has accelerated the launch of children's medicines by opening green channels for children's medicines and actively providing services to R&D companies.
In March 2020, the State Administration for Market Regulation issued the newly revised "Measures for the Administration of Drug Registration" and "Measures for the Supervision and Administration of Drug Production", which included urgently needed children's medicines in the scope of accelerated marketing registration.
In the "Outline of China's Children's Development (2021-2030)" released in September 2021, it is proposed to encourage the development and production of children's medicines, and improve the standards for children's clinical medicines.
Huang Xinyu, deputy director of the Medical Service Management Department of the National Medical Insurance Administration, said that the 2022 version of the national medical insurance drug catalog adjustment supports domestic innovative drugs, new crown therapeutic drugs, children's medicines and other key areas of medicines, which will further improve the level of children's drug protection.
Jiang Jiandong, academician of the Chinese Academy of Engineering and director of the Institute of Materia Medica, Chinese Academy of Medical Sciences, said that under the promotion of many national policies, the level of drug use for children in my country has improved significantly.
In the past few years, there have been urgently needed medicines for children on the market.
In 2021, a total of 47 children's medicines were approved for marketing across the country, 14 of which were included in the priority review and approval process, which promoted the marketing process of children's medicines and significantly improved the level of children's clinical medicines.
At present, there are still more children's medicines in the application process, and the problem of children's medicines in my country will be further improved.
Strengthen special research and development and clinical research of children's medicines
In addition to promulgating relevant policies, the state has also specially organized a special project for the research and development of children's medicines. The National Health and Medical Commission has invested more than 600 million yuan in the research of children's medicines through the major science and technology project of "Major New Drug Creation". Research plans, and jointly promote the development and production of children's medicines with the State Food and Drug Administration, the Ministry of Industry and Information Technology, and the National Medical Insurance Administration.
The National Health and Medical Commission established the National Children's Medical Center, organized 23 pediatric-related units across the country, and established the "China Pediatric Population Drug Clinical Trial Collaboration Network" to promote clinical research on children's medicines.
In 2022, the clinical research ward jointly built by the National Children's Medical Center and Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine will be officially opened.
The clinical research ward undertakes and completes phase I to phase IV clinical trials of drugs and medical devices in a standardized manner, creating a sharing platform for technological innovation and the combination of industry, education and research.
Professor Zhang Hao, Dean of Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine, said that protecting the rights and safety of child subjects and ensuring the science and standardization of drug clinical trials is the significance of building a clinical research ward. The clinical research ward will be dedicated to Solve problems such as the shortage of medicines for children in our country.
Technological innovation is also accelerating the development of children's medicines.
At the 2022 China International Fair for Trade in Services, the National Children's Medical Center demonstrated various new technologies to solve children's medication difficulties.
For example, mercaptopurine is an important drug for the treatment of children with acute lymphoblastic leukemia. Currently, the only 50 mg tablet sold in China is an adult tablet.
However, children need to calculate the dosage per kilogram of body weight, and the dosage changes with growth and development.
In order to solve this problem, Beijing Children's Hospital made breakthroughs in the key technologies of micro-tablet granulation and material fluidity, and developed an innovative dosage form of mercaptopurine micro-tablets that can be accurately dosed. drug system, etc.
Beijing Children's Hospital took the lead in undertaking the major scientific and technological project "Research and Development of Pediatric Drug Varieties and Key Technologies" of "Major New Drug Creation", and combined the research and development forces of 59 scientific research institutes, universities and enterprises across the country to develop children's drugs based on clinical needs.
At present, a total of 65 items such as production approval documents, acceptance numbers or clinical approval documents have been obtained.
"The research and development of these varieties has filled the gap in my country's children's drug market and effectively alleviated the shortage of clinical children's drugs." said Wang Xiaoling, director of the Pharmacy Department of Beijing Children's Hospital.
Efforts are still needed to promote the development of children's medicines
Xiao Lu, chief expert of the Science and Technology Development Center of the Chinese Pharmaceutical Association, said that to solve the dilemma of children's medicines for diagnosis and treatment, it is necessary to increase the R&D and production of children's medicines from the root cause, and provide certain support from policy and economic levels.
For pharmaceutical companies, the research and development cycle of children's medicines is long, the process is relatively complicated, and the production cost is high. According to the price difference principle, the price of children's medicines in my country is not much different from that of similar adult medicines. In addition, the dosage is relatively small, and it is difficult to motivate enterprises to develop research and development. , Production enthusiasm.
Chen Ruijie also said that the number of children's medicines is lower than that of similar adult medicines. If you want to mobilize the enthusiasm of enterprises in research and development and production, you must ensure that the relevant medicines can have reasonable profits.
Therefore, to improve the level of clinical children's drug use, centralized bidding and procurement of drugs and follow-up of medical insurance policies are indispensable.
"Medical insurance must pay enough attention to make companies confident in the development and production of children's medicines. In the centralized bidding and procurement of medicines, a suitable procurement method for children's medicines should be explored as soon as possible." Chen Ruijie said, in the respiratory and digestive system In addition to drug use, the relevant state departments also need to select areas where children's drug needs are relatively strong, such as common diseases, frequently-occurring diseases, hematological tumors and other major diseases, and orderly promote the continuous increase in the number of children's drug use.
The medical insurance department may consider formulating a payment standard and system for children's medicines that is different from adult medicines, so as to mobilize the enthusiasm of manufacturers and make medicines available to children.
"The next step is to encourage the R&D and production of children's medicines with greater efforts to ensure the safety of children's clinical medicines. This requires the joint efforts of all links and government departments." Xiao Lu said.