China Pediatric Drugs Encouraged for Research and Development – Fifth Batch

China pediatric drugs encouraged for research and development (R&D) have had their fifth batch jointly announced by the National Health Commission (NHC), the Ministry of Industry and Information Technology (MIIT), the National Healthcare Security Administration (NHSA), and the National Medical Products Administration (NMPA) on August 30, 2024.

This new list marks a significant step toward ensuring that the pharmaceutical industry can meet the unique and often complex clinical needs of pediatric patients in China. The list includes a total of 15 drug varieties, spanning 25 specifications and 8 dosage forms, focusing on therapeutic areas like systemic anti-infectives, respiratory drugs, anti-tumor agents, and immunomodulators.

Here is the list on these 15 drugs:

Key Features of the Fifth Batch

Focus on Pediatric Needs: The list prioritizes drugs that address significant clinical problems in children's healthcare, ensuring relevance for real-world medical use.
Adaptation to Pediatric Dosage Forms: Many of the drugs listed are already marketed but lack pediatric-friendly formulations like oral solutions or creams. The list emphasizes dosage forms that improve medication compliance in children.
Alignment with Rare Disease Treatment: The list includes drugs for rare diseases, ensuring a connection to the rare disease catalog to enhance treatment options for pediatric patients with these conditions.
Inclusion of R&D Potential: Drugs selected have undergone data-driven analysis to assess their development potential, market space, and ease of production. This process encourages pharmaceutical companies to participate in the R&D of children's drugs.

Selection Process and Criteria

The selection of drugs for the fifth batch was based on clinical necessity and advancements in drug development. The guiding principle was to meet the clinical demand for both effectiveness and suitability. Drugs were categorized into three groups: "new generic names” (referring to drugs that currently do not have a generic name in China), "new dosage forms," and "new specifications." The selection process also referenced the World Health Organization’s (WHO) Model List of Essential Medicines for Children. Emphasis was placed on new generic drugs and those with new indications approved by international regulators, particularly in Europe and the U.S.

Outcomes of the First Four Batches

Since 2016, four batches of the list have been released, encompassing 129 drugs. To date, 30 of these have been approved for market entry, addressing therapeutic areas such as the nervous system, digestive tract, cardiovascular system, and rare diseases. Several drugs that were previously unavailable in China, such as treatments for neonatal pulmonary hypertension and familial Mediterranean fever, are now accessible in China. Furthermore, 13 of the approved drugs now have dosage forms that are more suitable for children, which enhances compliance. The list has also generated corporate interest in R&D, with companies focusing on the practicality of production, supply chains, and market demand.

Supporting Policies and Future Directions

The NHC and its partners have implemented cross-departmental coordination to ensure the effective execution of policies related to children's drug development. These policies include fast-tracking approvals, incorporating pediatric drugs into essential medicine lists, and offering reimbursement support under national healthcare schemes.

Further information

Read the original announcement on China Pediatric Drugs Encouraged for Research and Development – fifth batch.

A clinical needs-driven approach in R&D for pediatric drugs is advisable. By focusing on the specific needs of pediatric patients and carefully evaluating production challenges, companies can enhance compliance and access to essential medications while promoting the development of important therapies for children's patients in China.