Regulatory considerations for paediatric drug evaluation in China
Open Access
- 2 May 2023
- journal article
- review article
- Published by BMJ in BMJ Paediatrics Open
- Vol. 7 (1), e001666
- https://doi.org/10.1136/bmjpo-2022-001666
Abstract
The regulatory guidelines for the research and development of paediatric drugs are still evolving in China. The formulation of the guidelines started from learning and borrowing existing experience, and gradually changed to the exploration and improvement of local guidelines, which was not only in line with international standards but also had breakthroughs, innovations and Chinese characteristics. In this paper, the current setting of paediatric drug research and development in China and corresponding technical guidelines have been introduced from regulatory perspectives, and the accessibility of further improvement in regulatory strategies has also been discussed.This publication has 3 references indexed in Scilit:
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- Off-label use of medicines in neonates, infants, children, and adolescents: a joint policy statement by the European Academy of Paediatrics and the European society for Developmental Perinatal and Pediatric PharmacologyEuropean Journal of Pediatrics, 2020
- First Dose in Neonates: Are Juvenile Mice, Adults and In Vitro–In Silico Data Predictive of Neonatal Pharmacokinetics of FluconazoleClinical Pharmacokinetics, 2014