Eight departments issue the implementation opinions on reforming and improving the guarantee mechanism for the supply of children's medicines.

On May 7th, the National Health Commission and 8 other departments issued the "Implementation Opinions on Reforming and Improving the Mechanism for Ensuring the Supply of Children's Medicines." The implementation opinions include 16 specific measures, such as improving the research and development innovation mechanism for children's medicines, improving the clinical application guidance principles for children's medicines, optimizing the management of children's medicine supply, strengthening the rational use of children's medicines, and increasing the supply of pediatric pharmaceutical services, to better meet the needs for disease prevention and treatment of children and comprehensively improve the ability to supply medicines for pediatrics. It mentions the improvement of the research and development innovation mechanism for children's medicines. Focusing on major diseases affecting children and the burden of medication, meeting urgent clinical needs, guiding collaborative research and filling gaps in medication. The National Science and Technology Major Project for Innovative Drug Development supports the research and development of innovative drugs for high-incidence diseases in children, combination vaccines, and dosage forms suitable for children's medicines (limited to drugs with clear indications and dosage for children in the drug instructions). Encouraging the development of new tools, methods, and standards necessary for the supervision of children's medicines. Promoting research on rare diseases and prevention and treatment of major diseases in children. Enhancing the approval process for children's medicines, full communication throughout the process and early intervention for innovative drugs specifically for children, allowing for rolling submissions of data to continuously improve research and development efficiency. The original text above: Implementation Opinions on Reforming and Improving the Mechanism for Ensuring the Supply of Children's Medicines National Health Commission Pharmaceutical Administration [2026] No. 10 Health commissions, industrial and information technology authorities, financial regulatory agencies, intellectual property offices, medical insurance bureaus, traditional Chinese medicine bureaus, disease control and prevention centers, and drug regulatory authorities of provinces, autonomous regions, municipalities directly under the central government, and the Xinjiang Production and Construction Corps: In order to better meet the needs for disease prevention and treatment of children, comprehensively improve the ability to supply pediatric medicines, further improve the system for children's medicines, accelerate the high-quality development of children's medicines, safeguard the health of children, the following opinions are put forward. 1. Highlight innovation research and development support, strengthen encouragement and guidance. (1) Improve the research and development innovation mechanism for children's medicines. Focusing on major diseases affecting children and the burden of medication, meeting urgent clinical needs, guiding collaborative research, and filling gaps in medication. The National Science and Technology Major Project for innovative drug development supports the research and development of innovative varieties for high-incidence diseases in children, combination vaccines, and dosage forms suitable for children's medicines (limited to drugs with clear indications and dosage for children in the drug instructions). Encourage the development of new tools, methods, and standards necessary for the supervision of children's medicines. Encourage research on rare diseases and prevention and treatment of major diseases in children. Improve the policy for declaring the development of children's medicines and the list of generic medicines, prioritize the approval of children's medicines included in them, prioritize the inclusion in the National Essential Medicines List and the National Major Science and Technology Major Project for Innovative Drug Development, and those that meet the requirements are included in the National medical insurance drug list according to the procedures. Strengthen full communication and exchanges throughout the process of the approval of children's medicines, early intervention for confirmed innovative drugs specifically for children, joint research and review, allow for the rolling submission of data, and continuously improve research and development efficiency. (2) Enrich the clinical research and development mode of children's medicines. Encourage and support the construction of pediatric research-oriented wards in national medical centers, national regional medical centers, and national clinical medical research centers, improve pediatric clinical high-level research platforms and comprehensive support systems. Explore the organization and establishment of a national pediatric clinical trial collaboration network and cross-institutional ethical review mechanism, concentrate resources, recruit research participants in a coordinated manner, and overall improve the level of standardization of pediatric clinical trial institutions. Support the multi-center cooperation model, establish unified data standards and analysis norms, strictly work procedures, improve real-world evidence and forward-looking research design, guide medical institutions to carry out collaborative research on drugs that are suitable for children but lack information on pediatric medicines, extrapolate drugs with existing Chinese adult data on safety to the Chinese pediatric population, improve pediatric patient medication information, and guide clinical medication. (3) Standardize children's medication information in drug instructions. Support qualified pediatric-related medical institutions and industry associations to propose the addition and improvement of important information such as pediatric indications and dosages to the drug instructions of chemical drugs and therapeutic biologics already on the market (excluding cell gene therapy products and blood products), according to regulations. In circumstances prescribed by law, if a drug's usage is not specified in the drug instructions but has evidence based on evidence-based medicine when being used for treatment, conduct medication assessment, organize authoritative organizations to develop related norms, and strengthen the link with drug regulatory policies. In accordance with the requirements for writing pediatric medication instructions, standardize the writing of pediatric medication dosages, revise the safety information items in the instructions in a timely manner, and more. (4) Innovate the research and development mechanism for pediatric traditional Chinese medicine. Fully utilize traditional Chinese medicine theory, clinical trial data, and experience with using traditional Chinese medicine for adults, conduct studies on traditional Chinese medicines that meet the physiological and pathological characteristics of children, establish a research paradigm and scientific evidence system that aligns with the characteristics of traditional Chinese medicine, highlights the advantages of traditional Chinese medicine, and caters to the clinical needs of pediatrics. Strengthen the development of improved new drugs in traditional Chinese medicine that cater to the growth and development characteristics of children and enhance children's medication compliance. Utilize traditional methods of Chinese medicine research and modern scientific technology to develop ancient classic pediatric formulas, increase the development and transformation efforts of pediatric traditional Chinese medicine products in medical institutions, screen the list of pediatric Chinese medicine specialties, promote the collection of human experience related to proprietary traditional Chinese medicines, accelerate the transformation of new traditional Chinese medicine. Accelerate the standardization and improvement of the functionality, indications, dosages, and cautionary information for children in the instructions of traditional Chinese medicines applicable to children, continuously enhance the safety of pediatric traditional Chinese medicine use. 2. Continuously enhance production and supply capacity, strengthen quality and regulatory supervision (5) Deepen the resilience of the children's medicine industrial chain supply chain. Continue to implement the high-quality development action plan for the pharmaceutical industry, enhance the supply capacity of children's medicines, appropriate dosage forms, and specifications. Support the inclusion of more children's medicines in designated production bases of small-size drugs (scarce drugs), adopt a relatively centralized production method to ensure supply, improve procurement policies for essential and easily scarce children's medicines, mobilize the initiative of enterprises in production and distribution. Continuously enrich the children's medicines in the central and local level reserves, continuously strengthen the monitoring of children's medicine production and guarantee factors such as specialized children's medicine auxiliary materials, enhancing the capability to secure the supply of children's medicines. During the high incidence period of seasonal infectious diseases, improve the collaborative monitoring, information sharing, early warning and response mechanism, strengthen the supply guarantee for commonly used children's medicines such as antiviral, antipyretic, and analgesic drugs. (6) Strengthen the quality supervision of children's medicines. Prioritize support for children's medicine production enterprises (including existing production lines that can be extended to produce children's medicines) to carry out technological transformation and equipment updates, promote enterprises' digital transformation, continuously improve the quality management system of children's medicine production, and enhance product quality. Strengthen the full-cycle traceability supervision of children's medicines, gradually achieve "one item, one code" full-chain traceability. Increase supervision and inspection of all varieties of children's medicines, pediatric formulations of medical institutions, strengthen sampling inspections, enhance monitoring and evaluation of adverse reactions, address key supervision areas such as children's medicines that are significantly below cost or have frequent changes in technology and auxiliary materials. (7) Improve the clinical application guidance principles for children's medicines. Revise the Chinese national formulary (children's edition) and update the clinical medication instructions. Focus on common pediatric diseases, develop clinical application guidance principles for children's medicines based on evidence-based medicine and clinical practice. Expand the range of children's medicine varieties, dosage forms, and specifications in the National Essential Medicines List, and explore the formulation of a national children's essential medicine list. (8) Strengthen the protection of intellectual property rights for children's medicines. Implement early resolution mechanisms for drug patent disputes and drug patent term compensation systems in accordance with the law, granting patent term compensation for related patents of children's medicines that meet the requirements, and enhancing the level of intellectual property protection for children's medicines. Provide data protection in accordance with the law for test data and other data submitted during the registration process of children's medicines. For new varieties of children's medicines, new dosage forms or specifications of children's medicines, and drugs with added pediatric indications, conditions permitting, grant a market exclusivity period of up to 2 years. Efforts should be made to protect pediatric traditional Chinese medicine, with appropriate linkage to the protection system for traditional Chinese medicine varieties. (9) Standardize the use and management of pediatric pharmaceutical formulations in medical institutions. Fully leverage the role of pediatric pharmaceutical formulations in meeting clinical medication needs and addressing drug shortages, support medical institutions to under the guidance of the children's drug workgroup of the drug management and pharmacotherapy committees of medicine use their drugs, evaluate and adjust the children's drugs in the drug supply catalog regularly. When selecting pediatric medicines, the restrictions of "one product, two rules" may not apply. Continuously carry out temporary importation of children's medicines, especially to ensure that medicines for rare diseases and major diseases are accessible. Medical consortia should strengthen the unified connection of pediatric medication management, promote the rational use of pediatric medicines within medical consortia. Improve the monitoring and reporting mechanism for the supply of pediatric medicines in medical institutions. Dynamically adjust the list of scarce drugs, including children's medicines, and the list of clinically necessary and easily scarce medicines, strengthen the monitoring and early warning of production and supply chain of easily scarce medicines, timely grasp the production dynamics of scarce pediatric medicines, and ensure the matching of supply and demand. 3. Improve payment guarantees, strengthen coordinated governance (10) Improve the management of children's medicine payments. Support and encourage the registration of drugs on the children's medicine list, and the inclusion of drugs that meet the conditions in the children's special drugs (drugs with only pediatric indications and dosages in the drug instructions) and children's appropriate dosage forms and drugs with clear pediatric indications and dosages in the medical insurance drug list. During the negotiation period, when a drug with a current agreement applies to add new pediatric indications, if it meets the conditions, it can be quickly renewed according to the established procedures. Promote the reform of medical insurance payment methods, appropriately tilt towards children in determining elements such as grouping and coefficients, dynamically adjust and improve disease grouping schemes. Enhance data support, support the development of commercial health insurance products for children, and encourage the inclusion of innovative drugs and orphan drugs in the coverage. (11) Optimize the procurement model for children's medicines. In the centralized procurement of drugs organized by the state, carry out grouped procurement for pediatric drugs and adult drugs separately. During the process of hanging on the provincial medical and drug procurement platform, implement the hanging rules of each province, optimize the rules for price differentials during the process of centralized drug procurement, incentivize the supply of pediatric appropriate dosage forms and specifications. Encourage the establishment of separate differentiated packaging for pediatric-specific dosage forms and specifications. 4. Improve the evaluation system and enhance service levels (12) Accelerate the construction of a comprehensive clinical evaluation system for children's medicines. Focusing on essential medicines, establish a children's medicine database, strengthen the collection and comprehensive analysis of data on children's medicine dosages, combination therapies, real-world studies, etc., organize the collection and organization of clinical application experiences for children, strengthen the monitoring of children's medicine use and the translation and application of comprehensive clinical evaluation results. Improve technical guidelines for comprehensive clinical evaluation of children's medicines, fully leverage the unique advantages of national and provincial medical institutions, research institutes, industry associations, etc., establish a cross-regional and multi-center collaborative mechanism for comprehensive clinical evaluation of children's medicines, and continually promote the standardization and homogenization of pediatric medicine clinical evaluation. Conduct a comprehensive clinical evaluation of pediatric traditional Chinese medicines and develop a clinical evaluation pathway for pediatric traditional Chinese medicines. (13) Optimize the management of the supply of children's medicines. Medical institutions should establish a sound selection system for children's medicines. Second-level or higher medical institutions specializing in pediatric medical services, under the guidance of the children's drug workgroup of the drug management and pharmacotherapy committees at their respective institutions, evaluate and adjust the children's medicines in their drug supply catalog regularly. When selecting children's medicines, they may not be restricted by the limitations of "one product, two rules." Continuously carry out temporary imports of children's medicines, especially to ensure access to medicines for rare diseases and major diseases. Medical consortia should strengthen unified connection of pediatric medicines, promote rational use of pediatric medicines in medical consortia. Establish a monitoring and reporting mechanism for the supply of children's medicines by medical institutions. Dynamically adjust the list of scarce medicines, including children's medicines, and the list of clinically necessary and easily scarce medicines, strengthen monitoring and early warning of production and supply chain for easily scarce medicines, timely grasp the production dynamics of scarce pediatric medicines, and ensure supply-demand coordination. (14) Strengthen the rational use of children's medicines in medical institutions. Medical institutions should implement the principles of safe, effective, and economical medication use, follow the clinical application guidelines, clinical practice guidelines, and drug instructions, strengthen management at every step including prescription by doctors, review by pharmacists, and administration by nurses, issue prescriptions reasonably after passing the audit. Strengthen the review of pediatric medication prescriptions, establish a close-knit medical consortia centralized prescription audit, use the results as the basis for regular assessment and performance management of pharmacists and doctors, ensuring the rational use of pediatric medicines. When using drugs for treatment with drug use not explicitly specified in the drug instructions but based on evidence-based medicine, medical institutions should establish a management system to review the appropriateness of doctor prescriptions and medication orders, strictly regulate doctor medication behavior. (15) Increase the supply of pediatric pharmaceutical services. Support national secondary and tertiary public comprehensive hospitals, tertiary Chinese medicine hospitals (including integrated Chinese-Western medicine hospitals, minority nationality medical hospitals), maternal and child health hospitals, etc., to provide pharmaceutical outpatient services and personalized medication monitoring services for pediatric patients. Pharmacists in closely-knit medical consortia can use community healthcare institutions' family doctor teams as platforms to provide suitable pharmaceutical services to children and caregivers. Encourage pharmacists in tertiary hospitals to establish regular pharmaceutical outpatient clinics or joint medical-pharmaceutical clinics at grassroots level, leverage the synergy between pharmacists and doctors, guide township health centers and community health service centers to provide continuous and standardized medication services for pediatric patients. Encourage medical institutions with conditions to carry out pediatric prescription (medical order) audits, joint ward rounds, consultations, pharmaceutical rearrangement, pharmaceutical monitoring, medication education, and other services. Optimize the promotion and assessment system for clinical pharmacists and explore adding pediatric medication related content to relevant health professional qualification exams. Develop technical standards and evaluation norms that align with the characteristics of pediatric pharmaceutical services. (16) Strengthen education and popularization of pediatric medicines. Medical institutions should provide guidance and education to caregivers on common issues related to medication use and post-medication care, establish a follow-up system for pediatric medication. Medical institutions should utilize various methods, including mobile internet applications, to conduct rational medication propaganda, preventive care, and related health education, guide parents of children to develop scientific medication concepts, improve safety awareness and adherence to pediatric medication. Establish a comprehensive media dissemination mechanism for children's medication and health knowledge, provide guidance to medical institutions, experts, organize and carry out activities such as "safe and rational medication into communities, into homes" based on characteristics such as seasonal changes in children's diseases, promote scientific parenting, disease prevention, timely medical treatment, and rational medication knowledge and skills, form a joint effort in pediatric health promotion and rational medication, guide the whole society to pay attention to and support the high-quality development of children's medicines. 5. Highlight key aspects, focus on organization and implementation Relevant departments and regions should further strengthen organizational leadership and work coordination. Health authorities should promote the implementation of relevant policies for ensuring the supply of children's medicines, organize and implement scientific and technological major projects related to the research and development of children's medicines, develop technical specifications related to children's medicines, guide medical institutions to implement policies for children's medicines, and relevant departments should improve the evaluation and training standards for clinical pharmacists in pediatric medicine. The traditional Chinese medicine authorities should actively study the industrial support policies for pediatric traditional Chinese medicine, and cooperate to guide the implementation of children's drug policies in Chinese medicine hospitals. Disease prevention and control authorities should support the work related to ensuring the supply of infectious disease prevention and control medicines for children. Industrial and information technology authorities should research and improve the policies for the technological transformation and upgrading of children's medicine production, industrial chain collaboration, and supply guarantee. Finance regulatory authorities should research and improve support policies for commercial health insurance for children's medicines. Intellectual property authorities should improve the protection system for intellectual property rights of children's medicines. Medical insurance authorities should study and improve support policies for medical insurance for children's medicines. Drug regulatory authorities should organize the prioritized review and approval of children's medicines and strengthen quality supervision. This opinion shall come into effect from the date of issuance. The "Several Opinions on Guaranteeing Children's Medicines" jointly issued by the former National Health and Family Planning Commission and 6 other departments [National Health Pharmaceutical Administration [2014] No. 29] shall be repealed simultaneously. National Health Commission Ministry of Industry and Information Technology State Administration of Banking and Insurance State Intellectual Property Office National Medical Insurance Bureau National Administration of Traditional Chinese Medicine National Center for Disease Control and Prevention National Medical Products Administration Source: National Health Commission official website; GMTEight Editor: Chen Xiaoyi.