The Center for Drug Administration of the State Drug Administration issued the "Patient-centered Drug clinical trial design Technical Guidelines (trial)" "Patient-centered drug clinical trial Implementation Technical Guidelines (trial)" "Patient-centered Drug Benefit - Risk Assessment Technical Guidelines (trial)" circular (No. 44 of 2023).

"Patient-centered" drug research and development refers to the process of drug development, design, implementation and decision-making based on the perspective of patients, aiming at efficient research and development of clinically valuable drugs that better meet the needs of patients, and is currently the field of active exploration by drug regulatory agencies in various countries. In order to promote the practical application of "patient-centered" concept in drug development, The Center for Drug Approval has organized and formulated the Technical Guidelines for Patient-centered Drug Clinical Trial Design (trial), the Technical Guidelines for Patient-centered Drug Clinical Trial Implementation (trial), and the Technical Guidelines for Patient-centered Drug Benefit-Risk Assessment (Trial) (see Annex 1-3). In accordance with the requirements of the Notice of the General Department of the State Drug Administration on the release procedure of the Technical Guidelines for Printing and Distributing Drugs (Comprehensive Drug Administration (2020) No. 9) of the State Drug Administration, it is hereby issued with the approval of the State Drug Administration and shall come into force as of the date of promulgation.

We hereby inform you.

Attachment:

1. Technical Guidelines for Patient-centered Drug clinical Trial Design (Trial)

2. Technical Guidelines for the Implementation of patient-centered drug clinical Trials (Trial)

3. Technical Guidelines for patient-centered drug Benefit-Risk Assessment (pilot)

State Drug Administration drug testing center

July 27, 2023

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