CDE: Guidelines for clinical pharmacological research on antibody drugs in the new coronavirus are published

On September 9, the Drug Audit Center of the State Drug Administration issued a circular on the Guidelines for Clinical Pharmacological Research and Technical Information Requirements for the Declaration of New Coronavirus and Antibody Drugs (Trial).
shall be effective from the date of publication.
The announcement is as follows: In order to actively respond to the outbreak of neo-coronary pneumonia and accelerate the development of new coronavirus-in-the-antibody drugs, and with the deployment of the State Drug Administration, the Drug Review Center has formulated the Guidelines for Clinical Pharmacological Research and Technical Information Requirements for the Declaration of New Coronavirus-in-the-Antibody Drugs (trial) (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 (Pharmaceutical Supervision and Administration No. 9 of 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 heeds this notice.
, September 9, 2020 Annex 1: Guidelines for clinical pharmacological research and technical information requirements for the declaration of new coronavirus and antibody drugs (trial) downloaded by the Drug Review Center of the State Drug Administration