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Notice of CDE of China NPMA on Issuing the Technical Guidance for CMC Changes of Innovative Drugs (Chemical Drugs) during Clinical Trials (Interim)

CCFDIE| Updated: 2021-03-15

In order to further cooperate with the implementation of innovative drug related policies set forth in the Drug Administration Law and the Provisions for Drug Registration, the CDE, under the guidance of NMPA, has organized to formulate the Technical Guidance for CMC Changes of Innovative Drugs (Chemical Drugs) during Clinical Trials (Interim), which was issued and implemented as of March 3.