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The circular pointed out that, taking into account the actual needs of china's children's drug research and development and drug registration, to help enterprises better understand the application of the guiding principles in children's drug research and development, the National Drug Administration, the deployment of the Drug Audit Center has developed guidelines.
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.
The guidelines point out that Real World Research (RWS), as one of the new research methods, has been gradually used to support the development and review of children's medicines, supporting the registration of new drugs, expanding childhood adaptations, and improving dose programmes for children.
this is in line with the previously released series of RWS policies.
it is worth noting that as early as January 7 this year, the State Drug Administration issued the Guidelines for Real-World Evidence Support Drug Development and Review (Trial), which states that the use of real-world evidence is a strategy for drug development in children.
May 19, CDE drafted and published the "Draft for Comments" on the Technical Guidelines for Real-World Evidence support for child drug development and review, again raising industry concerns about the scope of application of real-world evidence to support drug development in children.
industry insiders pointed out that the guidelines issued this time respond to industry concerns——— introduced the current real-world research to support China's children's drug research and development of common situations and concerns, and gave cases and explanations, I believe that this industry will have a very important reference value and guiding significance.
also seen regulators take another solid and important step in the study of drug authenticity.
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