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Big News! The CDE Releases a Trio of Guiding Principles for Drug Development “Patient-Centric”!!!
2023-08-04
“Patient-centered” drug development refers to the process of drug development, design, implementation, and decision-making conducted from the patient’s perspective. Its goal is to efficiently develop clinically valuable drugs that better meet patients’ needs—a field that regulatory agencies around the world are actively exploring. To promote the practical application of the “patient-centered” approach in drug development, the Center for Drug Evaluation has organized the drafting of the following guidelines: “Technical Guidance Principles for Patient-Centered Clinical Trial Design (Trial Version),” “Technical Guidance Principles for the Implementation of Patient-Centered Clinical Trials (Trial Version),” and “Technical Guidance Principles for Benefit-Risk Assessment of Patient-Centered Drugs (Trial Version)” (see Attachments 1–3).
2023-08-04
To implement the requirements of laws and regulations such as the "Drug Administration Law" and the "Measures for the Supervision and Administration of Drug Production," and to further standardize drug inspection practices, the National Medical Products Administration has, based on the actual situation of drug inspection work, revised the "Measures for Drug Inspection Management (Trial)" (hereinafter referred to as the "Measures"). The main revisions and improvements have been made to articles in Chapter 3, "Inspection Procedures," and Chapter 9, "Handling of Inspection Results" (see Attachment 1).
2023-07-21
To standardize and strengthen the management of pharmaceutical standards, establish the most rigorous pharmaceutical standards, ensure the safety, efficacy, and controllable quality of drugs, and promote high-quality development of pharmaceutical products, the National Medical Products Administration has formulated the “Measures for the Management of Pharmaceutical Standards,” which are hereby promulgated and shall take effect as of January 1, 2024.
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