Just! CDE issued "overseas listed domestic unlisted drugs clinical technical requirements" focus on 4 points!

The domestic listing or imitation of overseas listed drugs is an important means to solve the problem of the availability and accessibility of drugs in the field of clinical urgent needs of patients in China.
In order to speed up the process of listing such drugs and strengthen scientific supervision, the Pharmaceutical Review Center has organized and formulated the Clinical Technical Requirements for Unlisted Drugs in Overseas Marketed Territories in accordance with the Measures for the Administration of Drug Registration (General Administration Order No. 27) and its supporting documents (see annex).
In accordance with the requirements of the Notice of the General Division of the State Drug Administration on the Procedure for the Issue of Technical Guidelines for the Issue of Drugs (No. 9 of the Drug Administration (2020) ), it shall be issued with the approval of the State Drug Administration and shall come into effect as of the date of publication.
he hedes this notice.
Drug Review Center of the State Drug Administration, October 12, 2020.