BEIJING, June 1 (Xinhua) -- China's National Medical Products Administration on Saturday announced that it has approved the market entry of 21 medicines for children this year, with about a third being prioritized for accelerated entry.
In recent years, the administration has stepped up its policy support for the research and development (R&D), approval and production of medicines for children, resulting in market entry approvals for an increasing number of drugs.
Statistics show that since 2019, the administration has approved 271 medicines for children.
To address the clinical use of medicines for children with urgent needs, the administration has maintained close contact with R&D institutions to accelerate related work, while greenlighting review and approval procedures.
In addition, to improve the safety of the clinical use of medicines for children, the administration has issued a trial rule governing children-specific information that should be added to the package inserts of related approved medicines.
The administration said it will continue to make efforts to ensure the supply of medicines for children, pledging to implement greater preferential policies to facilitate the review and approval of such medicines, and to intensify the protection of related intellectual property rights.
It also pledged efforts to provide more technological guidance to R&D companies, ensuring special requirements such as safety and suitability for children are taken into full consideration in R&D processes. ■
