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Guide: To help companies better understand the application of the Guiding Principles for Real-World Evidence Support Drug Development and Review (Trial) in Children's Drug Research and Development.
. Taking into account the actual needs of china's children's drug research and development and drug registration, to help enterprises better understand the real-world evidence-backed drug research and development and review guidelines (trial) in children's drug research and development, the National Drug Administration, the deployment of the Drug Review Center organized the development of real-world research to support children's drug research and development and review of the technical guidelines (trial) (see annex).
In accordance with the requirements of the Notice of the General Division of the State Drug Administration on the Procedure for the Issue of Technical Guidelines for the Issue of Drugs (No. 9 of the Drug Administration (2020) ), it shall be issued with the approval of the State Drug Administration and shall come into effect as of the date of publication.
he hedding this notice.
Drug Review Center of the State Drug Administration on August 27, 2020.
