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Big News! The CDE Releases a Trio of Guiding Principles for Drug Development “Patient-Centric”!!!
Release time:
2023-08-04 17:05
Source:
“Patient-centered” drug development refers to the process of drug development, design, implementation, and decision-making conducted from the patient’s perspective. It aims to efficiently develop clinically valuable drugs that better meet patients’ needs—a field that is currently being actively explored by regulatory agencies worldwide. To promote the practical application of the “patient-centered” approach in drug development, the Center for Drug Evaluation has developed the following guidelines: “Technical Guidance Principles for Patient-Centered Clinical Trial Design (Trial Implementation),” “Technical Guidance Principles for Patient-Centered Clinical Trial Implementation (Trial Implementation),” and “Technical Guidance Principles for Patient-Centered Benefit-Risk Assessment of Drugs (Trial Implementation)” (see Attachments 1–3). In accordance with the requirements of the “Notice of the Comprehensive Division of the National Medical Products Administration on Issuing Procedures for the Publication of Pharmaceutical Technical Guidance Principles” (NMPA Comprehensive Drug Administration [2020] No. 9), these guidelines have been reviewed and approved by the National Medical Products Administration and are hereby released, effective from the date of their publication.
Hereby notified.
Attachment:
1. Guiding Principles for the Design of Patient-Centered Clinical Trials (Trial Version)
2. Technical Guidance Principles for Conducting Patient-Centered Clinical Trials of Drugs (Trial)
3. Guiding Principles for Patient-Centered Drug Benefit-Risk Assessment (Trial)
Center for Drug Evaluation, National Medical Products Administration
July 27, 2023
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