CDE publishes "Guidelines for Drug Registration Acceptance Review (Draft for Comment)"

On February 18, CDE issued the "Guidelines for the Acceptance and Review of Drug Registration (Trial) (Draft for Comment)", soliciting opinions on three aspects: traditional Chinese medicine, chemical drugs, and biological products.
The publicity date is from February 18, 2022 to March 2022.
4th of May
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The original text is as follows:

Notice on the public solicitation of opinions on the "Guidelines for the Acceptance and Review of Drug Registration (Trial) (Draft for Comment)"

"Notice of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the Guidelines for the Acceptance and Review of Registration of Chinese Medicines (Trial)" (No.
34, 2020), "The Center for Drug Evaluation of the State Food and Drug Administration on Issuing the Guidelines for the Acceptance and Review of the Registration of Chemical Drugs (for Trial Implementation)" > Notice (No.
10, 2020), "Notice of the Center for Drug Evaluation of the State Food and Drug Administration on Issuing the <Guidelines for Registration Acceptance and Review of Biological Products (Trial)>" (No.
11, 2020) In order to update and disclose the acceptance standards in a timely manner, improve the quality of acceptance work, and better serve the applicants, and at the same time to implement the "Implementation Measures for the Early Resolution Mechanism of Drug Patent Disputes (for Trial Implementation)" It is proposed to revise the guidelines for the acceptance and review of registration of traditional Chinese medicines, chemical drugs and biological products
.

The announcement date is: February 18, 2022 to March 4, 2022

Feedback Email: Traditional Chinese Medicine: zyshoulizhinan@cde.

Chemicals: hxypshoulizhinan@cde.

Biological products: swzpshoulizhinan@cde.