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Latest! CDE Releases New Regulations for Dissolution Curve Research!

 Last Update: 2022-11-26
 Source: Internet
 Author: User

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In order to standardize and guide the research on dissolution curves during pharmaceutical changes of listed chemicals and provide technical standards for reference, under the deployment of the State Medical Products Administration, the Center for Drug Review organized and formulated the Q&A on dissolution curve research of "Technical Guidelines for Research on Pharmaceutical Changes of Listed Chemicals (Trial)" (see annex).

In accordance with the requirements of the Notice of the General Department of the State Food and Drug Administration on the Procedures for Issuing Technical Guidelines for Drugs (Drug Administration [2020] No.
9), after the review and consent of the State Medical Products Administration, it is hereby issued and will come into force
on the date of promulgation.

Notice is hereby given
.

Annex: Q&A on dissolution curve research of "Technical Guidelines for the Study of Pharmaceutical Changes of Listed Chemicals (Trial)"

Drug Review Center, State Food and Drug Administration

November 7, 2022

Related attachments

serial number	Attachment name
1	Q&A . pdf for dissolution curve research in the Technical Guidelines for the Study of Pharmaceutical Changes in Listed Chemicals (Trial).

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