The CDE has issued this guidance to assist researchers in understanding the application of real-world evidence in the R&D and clinical trials concerning pediatric drugs.
The CDE previously published “Guiding Principles for Drug Development and Evaluation Supported by Real World Evidence (Trial)” and, the Center for Drug Evaluation organized and formulated the “Technical Guidelines for Real-World Research Supporting Child Drug Development and Evaluation (Trial)” ) by taking into account the actual needs of the country’s pediatric drug development and drug registration. It also helps the industry better understand the application in the development of pediatric drugs.
This guidance was released based on the practical needs of the regulatory assessment of China, research and development of pediatric drug R&D, and as well for the implementation of ICH E11 (R1). The guideline takes into consideration and prioritizes the real-world evidence (RWE)in support of R & D procedures of the pediatric drugs. The range of pediatric drugs includes chemical drugs, biological products, and Chinese. The document entails the following contents:- i) General Introduction, ii) Common case of application of RWE in R & D procedure of pediatric drug development in China; and iii) Combination and comparisons of RWE and traditional randomized controlled clinical trials in pediatric drug R&D
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