In order to actively fulfill related requirements of the State Council on the medication of children, on July 15, 2021, a special session was held in Haikou by the Center for Drug Evaluation, NMPA, Hainan Medical Products Administration, Lecheng Administration, clinical and statistical experts and some manufacturers of children’s drugs to discuss related issues in addressing the medication evidences for children with real-world studies.

At the meeting, the working group of the Center for Drug Evaluation for children’s drugs delivered a keynote speech on the exploration of using RWE to support the extension of children’s application and introduce the Technical Guidance for Real-World Research/Study Supporting Research & Development and Evaluation of Pediatric Drugs (Interim), and proposed the regulatory strategies for meeting the medication needs of children under various circumstances.

At the seminar, the regulators, clinical and statistical experts and enterprise representatives fully communicated and exchanged views on the use of real-world studies in supporting and providing medication evidences for children and expanding the indications of pediatric drugs, research methods and focuses. The meeting was attended by Zhou Siyuan, deputy director of the Center for Drug Evaluation, NMPA, director Yang Zhimin, deputy director Xie Songmei and related reviewers.