Medical Policies Weekly ( Issue 23，2020）
1、The NMPA issued Settlement Procedures of Objection to the Conclusion of Drug Registration Review (Trial)
To cooperate with the implementation of Provisions for Drug Registration, the NMPA issued Settlement Procedures of Objection to the Conclusion of Drug Registration Review (Trial) on September 1 and it took effect as of the date of release. These procedures are applicable to the situation where the drug registration applicant raises an objection to the review conclusion with the content of not being approved which is proposed by the NMPA and the CDE, and the CDE organizes the handling of objection.
2、The CDE issued Technical Guidelines for Real World Research to Support Pediatric Drug Development and Evaluation (Trial)
Considering the actual needs of China’s pediatric drug development and research as well as drug registration and to help enterprises better understand the application of Technical Guidelines for Real World Research to Support Drug Development and Evaluation (Trial) in pediatric drug development, CDE recently officially issued Technical Guidelines for Real World Research to Support Pediatric Drug Development and Evaluation (Trial) after soliciting public opinions in the early stage. The guidelines highlight the common situations and concerns of real-world studies in supporting pediatric drug development in China at the present stage, including post-marketing clinical safety and efficacy studies of new active ingredients approved for use in children in China; for drugs approved for adults and children abroad and for adults in China, the extrapolation strategy of data is adopted to apply for children in China; for common clinical drugs listed in China, off-label drug use data is adopted to support the extension of indications to children; rare diseases and other conditions. The guidelines are applicable to all types of pediatric medicines, including chemicals, traditional Chinese medicines and biological products.
3、The CDE solicited public opinions on Guidelines for Clinical Pharmacology Research on Pediatric Drug Use (Draft for Comments).
In order to meet the needs of pediatric drug development and registration in China, encourage the use of new technologies and new methods to carry out clinical trials of pediatric drug use, and to further clarify the technical requirements of clinical pharmacology of pediatric drug use, the CDE recently issued Guidelines for Clinical Pharmacology Research on Pediatric Drug Use (Draft for Comments) and solicited public opinions. Based on the differences of children's physical development from adults, the guidelines expound the special considerations clinical pharmacology of pediatric medicine takes, and clarify the clinical pharmacology research required to carry out in pediatric drug research and development, difficulties and solutions met in the practical level, application of solutions and model simulation method in the development process, thus providing ideas for pediatric drugs development and research.
