Taking Multiple Measures to Care for Children's Health Medications | Children | Health
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In the first five months of this year, 34 pediatric medications were approved for marketing; In March of this year, the new version of the National Medical Insurance Drug Catalogue was officially implemented, with new drugs covering 22 children's medication; In January of this year, the General Office of the National Health Commission issued a notice encouraging medical institutions to develop new technologies and methods that can flexibly adjust dosage for pediatric medication, strengthen standardized management and quality control of personalized medication
China has taken a series of measures to encourage the research and production of children's medication, and continuously improve the level of drug supply guarantee.
According to data from the National Bureau of Statistics, at the end of 2022, the population aged 0-15 in China was 25.615 million, accounting for 18.1% of the total population.
Compared with adult medication, the research and development and production of pediatric medication face problems such as late start, high difficulty, and weak foundation, which require joint efforts from medical institutions, research institutes, and pharmaceutical companies to solve.
In January of this year, the General Office of the National Health Commission issued a notice on further strengthening the management of clinical medication for children, encouraging medical institutions to develop new technologies and methods that can flexibly adjust dosage for children's medication; In March, the new version of the National Medical Insurance Drug Catalogue was officially implemented, with new drugs covering 22 children's medications; In the first five months of this year, 34 children's drugs have been approved for marketing, exceeding the same period last year... China has taken a series of measures to encourage the research and development and production of children's drugs, continuously improving the level of drug supply guarantee.
Breaking through key technologies and filling market gaps
The challenge faced by some children and parents when taking medication was to rely on persuasion and guessing the dosage. "Children are not the epitome of adults, and medication for children needs to be 'tailored'," said Ni Xin, director of the National Children's Medical Center and director of Beijing Children's Hospital.
Taking mercaptopurine, an important drug for treating childhood acute lymphoblastic leukemia, as an example. At present, the only specification for selling mercaptopurine on the market is a 50 milligram tablet with a diameter of approximately 1 centimeter, all of which are adult tablets. Children taking mercaptopurine need to calculate the dosage based on kilograms of body weight, and adult tablets should be cut or ground, which is inconvenient to use and has low accuracy.
To solve this problem, the National Children's Medical Center and Beijing Children's Hospital have taken the lead in breaking through key technologies and developing precise and measurable improved formulations of mercaptopurine. The tablet has a diameter of 2 to 3 millimeters and is the size of a grain of rice, which is beneficial for children to swallow. This achievement has been unveiled at the 2022 China International Fair for Trade in Services.
"The variety, dosage form, and specifications of pediatric medication in China are generally insufficient compared to adult medication. About 45% of drug instructions in pediatric clinical medication lack pediatric usage and dosage, leading to a significantly higher risk of medication errors in children than in adults." Wang Xiaoling, Director of the Pharmacy Department of Beijing Children's Hospital, said that integrating resources, breaking through a series of core key technologies, and conducting rational pediatric clinical research are the key to achieving efficient research and clinical transformation of pediatric medication.
In recent years, Beijing Children's Hospital has been committed to the research and development of pediatric medication. Wang Xiaoling introduced that Beijing Children's Hospital has taken the lead in undertaking the major special project of "Children's Drug Varieties and Key Technology Research and Development" in the 13th Five Year Plan for the creation of new drugs. It has joined forces with 59 research institutes, universities, and enterprises nationwide to strengthen technological innovation and develop children's drugs. At present, 65 relevant approvals, acceptance numbers or signing numbers have been obtained, filling the gap in China's pediatric medication market and alleviating the current shortage of pediatric medication in the market.
In addition, the National Health Commission has invested over 600 million yuan in the research of pediatric medication through major new drug creation technology projects; Establish the National Children's Medical Center, organize 23 national pediatric related units, establish the "China Pediatric Population Drug Clinical Trial Collaboration Network", and promote clinical research on pediatric medication.
Accelerate review and approval, stimulate innovation momentum
"My son has finally used domestic chloramphenicol!" Ms. Zhang from Henan excitedly said, "My child was diagnosed with epilepsy at the age of two and needs to take the treatment drug chloramphenicol. The launch of domestic chloramphenicol has solved a big problem for us."
In May 2022, the National Center for Drug Evaluation will prioritize the application for the marketing of generic drug Chlorphenicol tablets for the treatment of epilepsy patients aged 2 years and above. In September, China's first domestically produced chloramphenicol generic drug was approved for market launch. Shortly thereafter, batches of chloramphenicol tablets were taken off the production line and gradually entered hospitals in more than 20 provinces, effectively alleviating the problem of medication shortage in children with epilepsy.
Lobazhan tablets are a microcosm of the results of drug review and approval for children in China in 2022. As a drug technology evaluation institution, the National Medical Examination Center optimizes the review and approval mechanism for pediatric medication, and stimulates industrial innovation vitality. Since 2021, the National Drug Administration has established a special leadership group and working group for children's medication, established a special label for "children's medication", shortened the approval time by 35%, and accelerated the listing of children's medication.
According to data from the National Medical Products Administration, a total of 66 pediatric drug varieties passed technical reviews in 2022, a significant increase from 47 in 2021, including 21 priority review and approval varieties and 11 encouraged research and development applications for pediatric drug list varieties. These products are accelerating their launch, further meeting the medication needs of pediatric patients.
To solve the problems of limited variety and dosage forms of children's medication, it is necessary to stimulate the research and development motivation of enterprises. The National Medical Examination Center has established an evidence system for the evaluation of pediatric drug research and development in accordance with the principle of "urgent use first", guiding enterprises to smoothly carry out research and development. At present, more than ten special guidelines for pediatric medication have been released, improving clinical trials and safety evaluation standards for pediatric medication, providing important technical support and evaluation basis for research and development and evaluation.
Accelerating the introduction of overseas marketed drugs is also an important way to meet the medication needs of pediatric patients in China. In recent years, the National Medical Products Administration, in conjunction with the National Health Commission, has organized experts to select and publish a list of urgently needed overseas new drug varieties in clinical practice, encouraging overseas pharmaceutical companies to come and apply, and establishing a special channel for evaluating the declared varieties. China has accelerated the approval of 16 children's medication varieties, including Noxinasone Sodium Injection, for the treatment of spinal muscular atrophy, bringing new hope for improving the survival rate and quality of life of children.
Strengthen multi-party cooperation to promote research and development production
"There is still a gap between China and the international leading level in the research and development of suitable preparations for children and independent production, as well as the research and development of drugs for major and rare diseases." Wang Xiaoling admitted.
How to overcome the problem of medication for children? Wang Xiaoling suggests establishing a special research and development project for children's medication, focusing on cutting-edge issues and key technologies, integrating basic research and transforming application resources, and achieving independent innovation and variety transformation of children's medication characteristic technologies.
"We should encourage medical institutions to collaborate with research institutes and enterprises to develop new technologies and methods that can flexibly adjust drug doses, establish personalized dispensing platforms for young children, and promote personalized dispensing of medication for children. For pediatric medical institutions' formulations with definite therapeutic effects, obvious characteristic advantages, and fewer adverse reactions, the cross provincial dispensing process should be simplified to meet clinical medication needs." Wang Xiaoling said.
Zhang Shuyang, the director of Beijing Union Medical College Hospital, proposed to further improve the research and development catalog of pediatric drugs on the basis of the existing list of drugs for children, guide priority research and development, and meet the clinical medication needs of pediatrics. Mobilize the enthusiasm of enterprises to participate in children's drug research and development through tax reduction, targeted subsidies, and designated production. Strengthen basic and clinical research on pediatric drugs, promote the improvement of pediatric medication information in adult drug instructions, and encourage international certification of pediatric drugs. Continuously strengthen technical guidance for standardized pediatric research, and improve the safety guarantee of clinical trials of drugs in pediatric populations.
"Different fields of pediatric diseases face different medication problems." Ni Xin believes that the treatment of some common and frequently occurring diseases in children lacks suitable drug dosage forms and specifications for young children, there is a lack of pediatric medication data for the treatment of major diseases such as blood tumors, and there is a lack of medication for rare diseases in children.
Ni Xin suggests that on the one hand, efforts should be made to increase the research and development of new drugs. Pediatric experts and drug manufacturing enterprises should strengthen cooperation and carry out scientific research and research breakthroughs; On the other hand, for the latest and truly effective innovative drugs from abroad, timely indication research should be carried out, and they should be introduced to China in a timely manner to ensure that patients have access to medication as soon as possible.
"The research and development of children's medication is difficult, the process is relatively complex, and the production cost is higher. In addition, the dosage is relatively small, and some pharmaceutical companies have insufficient enthusiasm for research and development and production." Yang Jie, the person in charge of Dayin Pharmaceutical, suggested that relevant departments should formulate policies to encourage the admission and pricing of children's medication, so that enterprises have a certain profit margin, thereby encouraging them to invest more manpower and financial resources in the research and production of children's medication.
