New notification! Notice on CDE's public solicitation of opinions on the Q&A (draft for soliciting opinions) of the Technical Guidelines for Pharmaceutical Changes in Chemical Drugs (Trial) for Raw Material Drug Changes!

The Guiding Principles for Research on Pharmaceutical Changes in Listed Chemical Drugs (Trial) stipulate that when there are various changes to the original and auxiliary packaging, the holder of the drug marketing license shall conduct necessary research on the formulation based on the changes in the original and auxiliary packaging. In order to better guide enterprises in conducting pharmaceutical change research, our center has conducted research and discussions with experts and industry, and organized the drafting of the Guiding Principles for Research on Pharmaceutical Changes in Listed Chemical Drugs (Trial) "Q&A on changes in active pharmaceutical ingredients (draft for soliciting opinions)" provides a detailed interpretation of the research work that should be carried out by relevant formulation holders when changing active pharmaceutical ingredients in the change guidance principles, and further clarifies some of the content in the chapter on changing active pharmaceutical ingredient suppliers.

We sincerely welcome valuable opinions and suggestions from all sectors of society on the draft for soliciting opinions, and provide timely feedback to us for further improvement. The time limit for soliciting opinions is one month from the date of publication.

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　　2023年09月01日