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NMPA CDE Announcement on Issuing the Technical Guidance for Quality Control Study of Nano Drugs (interim), Technical Guidance for Non-Clinical Pharmacokinetic Study of Nano Drugs (interim), and Technical Guidance for Non-Clinical Safety Evaluation Study of Nano Drugs (interim)

CCFDIE|Updated: 2021-08-27

     

In order to standardize and guide the study and evaluation of nano drugs, under the deployment of the National Medical Products Administration, the Center for Drug Evaluation has organized to formulate the Technical Guidance for Quality Control Study of Nano Drugs (interim), Technical Guidance for Non-Clinical Pharmacokinetic Study of Nano Drugs (interim), and Technical Guidance for Non-Clinical Safety Evaluation Study of Nano Drugs (interim), which were issued and implemented on August 27, 2021 upon review and approval by the National Medical Products Administration.