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Circular of the center for drug examination of the State Food and Drug Administration on Issuing the technical requirements for pharmaceutical researc

2021-03-10 16:10:50 vcc 9

(Trial) (No. 21, 2021)

Date of issue: 20210308

In order to further guide enterprises to carry out drug R & D and accelerate the process of R & D and listing of overseas-listed and domestic unlisted chemical drugs, reference technical standards are provided. Under the deployment of the State Drug Administration, the drug approval center has organized and formulated the technical requirements for pharmaceutical research and evaluation of overseas-listed and domestic unlisted chemical drugs (for Trial Implementation) (see Annex). According to the requirements of the notice of the General Department of the State Food and Drug Administration on the issuance procedure of the guiding principles of drug technology (yjzyg [2020] No. 9), and with the approval of the State Drug Administration, it is hereby issued and shall come into effect as of the date of issuance.

Notice is hereby given.

      Drug evaluation center of State Drug Administration

                               March 3, 2021

附件 1 :《境外已上市境内未上市化学药品药学研究与评价技术要求(试行)》.pdf