(Yicai) May 8 -- China will grant qualifying developers of innovative pediatric medicines up to two years of market exclusivity in an effort to encourage investment in children’s drug research and strengthen pharmaceutical innovation.

The new policy document, issued yesterday by the National Health Commission together with seven other government ministries, also introduces patent term compensation for pediatric drugs that meet certain requirements.

The document, which marks the first revision to China’s 2014 framework for ensuring pediatric drug supply, prioritizes the R&D of novel treatments for common childhood diseases, combination vaccines, child-appropriate dosage formulations, and medicines for rare diseases in children.

For designated innovative pediatric treatments, regulators will support developers through earlier regulatory engagement, coordinated review and assessment procedures, and rolling data submissions aimed at improving the overall efficiency of drug development.

To address persistent challenges such as low R&D efficiency and difficulties in recruiting pediatric trial participants, the government will promote research into new regulatory tools, methodologies, and standards, while also looking at setting up a nationwide pediatric clinical trial network and a cross-institutional ethics review system.

Regulators also pledged to support the use of real-world evidence and prospective study designs in multi-center research collaborations, while encouraging the extrapolation of existing Chinese adult safety data to pediatric populations where scientifically appropriate.

In addition, applications for the registration of drugs included on the government’s encouraged lists of innovative children’s medicines and selected generic drugs will receive priority review and approval, along with faster consideration for inclusion in the National Essential Medicines List.

The National Health Commission, working with the National Medical Products Administration, will compile a list of pediatric formulations commonly used by hospital that are clinically necessary but either unavailable on the market or unavailable in child-appropriate forms and dosages. The authorities will also draft clinical-use guidelines for pediatric drugs and explore the creation of a dedicated National Essential Medicines List for children.

Regulators will support the development of commercial health insurance products for children that cover innovative therapies and rare-disease medicines. At the same time, incentives will be introduced within China’s centralized drug procurement program to strengthen the supply of formulations and specifications suitable for children.

Editors: Tang Shihua, Futura Costaglione