China enhances drug safety for children

The Chinese government on Friday released a circular on ensuring drug safety for children, raising requirements in various aspects such as research and development, supply and quality management.

Released by six departments, including the National Health and Family Planning Commission (NHFPC) and the China Food and Drug Administration, the document noted that pharmaceutical companies lack motivation to research and develop medicines fit for children, and the improper use of medicines still exists.

According to the document, medicines that are urgently needed for clinical use should be fast-tracked when applying for official approvals, and a list of drugs that should enjoy priority in research and development will be compiled to guide drug companies. [ Meanwhile, companies must provide results of clinical trials and other related data for products on the market as well as those awaiting approvals as references for future research and supervision.

The circular said favorable policies will support companies to improve children's products and price them moderately, and the government will coordinate manufacturing, procurement and storage of medicines that are crucial and might easily run out for clinical use.

According to the circular, health authorities will draft an official manual for children's use of medicines, and companies must revise and improve their product manuals.

"Many product manuals lack details on specific dosages recommended for children as well as possible adverse effects, and doctors have to rely on their own experiences when prescribing," the NHFPC said in a Friday statement explaining the circular.

Most Chinese medicines are designed and packaged for adult consumption, and instructions for children are usually vague, such as "children should take less than the recommended dosage and use with caution." That leaves parents breaking a tablet into roughly sized pieces or pouring out syrups in doses of whatever quantity they see fit.

According to the NHFPC, the new circular will encourage drug makers to make medicines specially designed for children.

In addition, it urged regulation of traditional Chinese medicines for children's use concerning their functions, consumption, dosage and adverse reactions.

The NHFPC vowed that China will establish a system to regulate and evaluate the clinical use of children's medicines.