Economic Observation Network According to CCTV.com and the website of the National Health Commission, the commission has released a policy interpretation of the "Implementation Opinions on Reforming and Improving the Mechanism for Ensuring the Supply of Medication for Children".

1? Revision Background and Basis

In 2014, the former National Health and Family Planning Commission and six other departments jointly issued the "Several Opinions on Ensuring Children's Medication Use" (Guowei Yaozhengfa [2014] No. 29), which is China's first comprehensive policy document on children's medication use. Since the implementation of the document, various departments have introduced multiple policy measures around children's medication and formed a joint effort to promote it as a whole, which is of great significance for ensuring children's medication. Overall, with the continuous improvement of children's medication policies in recent years, children's medication can basically meet the needs of common clinical diseases, but there are still some outstanding problems that need to be urgently solved. One reason is that the quantity of medication used for children is limited, and there is a lack of suitable dosage forms and specifications for children, resulting in an imbalanced structure. The second issue is that there are still problems such as lack of information and non-standard use of medication for children in the instructions of marketed drugs. Thirdly, the enthusiasm of enterprises to develop and produce drugs for children has not been effectively stimulated, and the supply capacity of clinically necessary but low dosage pediatric drugs is still insufficient. Fourthly, the overall supply of pediatric pharmaceutical services is insufficient, and some medical institutions have fewer types of medications for children.

Faced with the new requirements and characteristics of pediatric medication, the 2014 pediatric medication documents have gradually become incompatible with the new stage and tasks, and cannot meet the high-quality requirements of the people for medical medication. It is necessary to revise and improve them.

In order to implement the deployment of the Third Plenary Session of the 20th Central Committee of the Communist Party of China and promote the implementation of key tasks in deepening the reform of the medical and health system, based on sufficient research, we have studied and drafted the "Implementation Opinions on Reforming and Improving the Mechanism for Ensuring the Supply of Children's Medication" (hereinafter referred to as the "Implementation Opinions").

2? Main content of document revision

One is to solve the problem of drug development for children. Strengthen the full communication and exchange throughout the review and approval process, and allow for early intervention and research review linkage of innovative drugs for children, allowing for rolling submission of materials. The relevant departments shall give priority to the review and approval of drugs included in the list of encouraged children's drugs and the list of encouraged generic drugs, and prioritize their inclusion in the national essential drug list and the national science and technology major special project for innovative drug research and development. They shall also be included in the national medical insurance drug list according to procedures.

The second is to enrich the clinical research and development model of pediatric medication. Encourage and support the construction of pediatric research-oriented wards such as national medical centers, national regional medical centers, and national clinical medical research centers. Explore the establishment of a national collaborative network for children's clinical trials and a cross institutional ethical review mechanism. Promote the extrapolation of drug safety from existing adult data in China to the pediatric population in China.

The third is to improve the clinical application of pediatric medication. Support pediatric related medical institutions, industry associations, etc. that meet the requirements to propose and supplement important information such as indications, usage, and dosage in the instructions for children in accordance with regulations. The National Health Commission will take the lead in formulating clinical application guidelines for children's medication, revising the Chinese National Formulary (Children's Edition), and exploring the timely development of the National Essential Medicines List for Children.

Fourthly, standardize the use of pediatric preparations in medical institutions. The National Health Commission will work with the National Medical Products Administration to develop a list of commonly used pediatric medical institution preparations for formulations and specifications of pediatric drugs that are clinically necessary but not available or available in the market for use by children.

The fifth is to strengthen the monitoring of shortage drugs and ensure their supply. Support the inclusion of more children's medication in the designated production varieties of small seed medicine (shortage medicine) centralized production bases. Enrich the reserve of children's medication at both the central and local levels. Strengthen the supply guarantee of commonly used children's medicines such as antiviral, antipyretic, and analgesic during the high incidence period of seasonal infectious diseases. In addition, we will continue to carry out temporary import work to ensure medication for special populations such as rare diseases and major illnesses.

Sixth, establish a sound payment management system. Propose to promote the reform of medical insurance payment methods, dynamically adjust and improve disease grouping schemes, and appropriately tilt towards children when determining grouping, coefficients, and other factors. Strengthen data support, support the development of children's insurance coverage products for commercial health insurance, and encourage the inclusion of innovative drugs and rare disease medications in the coverage scope. In the centralized procurement of drugs organized by the state, children's specific drugs and adult drugs are purchased in groups. Optimize the rules for price comparison and incentivize the supply of suitable dosage forms and specifications for children.

The Implementation Opinions also put forward clear requirements for innovating the research and development mechanism of traditional Chinese medicine for children, strengthening quality supervision, enhancing intellectual property protection, increasing the supply of pediatric pharmaceutical services, and strengthening the promotion of children's medication.

3? What are the safeguard measures

The National Health Commission, together with the Ministry of Industry and Information Technology, the State Administration of Financial Supervision, the China National Intellectual Property Administration, the State Health Insurance Bureau, the State Administration of Traditional Chinese Medicine, the State Administration for Disease Control and Prevention, and the State Food and Drug Administration, has established a mechanism for cross sectoral information sharing, communication and consultation, and collaboration. According to their respective responsibilities, they have promoted the convergence and collaboration of the whole chain of policies on children's drug research and development, registration, production, use, and reimbursement, so as to form a joint force of work, and promote the solution of key and difficult problems in the industry from one point to another, so as to better meet the needs of.