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Effective November 1, 2024! Notice on Providing Early-Stage Acceptance Services for Innovative Drugs and Varieties That Have Been Confirmed Through Communication and Consultation as Eligible for Priority Review and Approval Procedures and Conditional Approval Procedures.

Effective November 1, 2024! Notice on Providing Early-Stage Acceptance Services for Innovative Drugs and Varieties That Have Been Confirmed Through Communication and Consultation as Eligible for Priority Review and Approval Procedures and Conditional Approval Procedures.

2024-10-24

Starting November 1, 2024, applicants for marketing authorization of innovative drugs—as well as products that have been confirmed through communication and consultation to be eligible for the priority review and approval procedure and the conditional approval procedure—will receive early-stage acceptance services.

Big News! The Center for Drug and Food Review and Inspection of the National Medical Products Administration has issued a notice on the release of the “Guidelines for Filling Out the Annual Work Summary Report of Clinical Trial Institutions.”

Big News! The Center for Drug and Food Review and Inspection of the National Medical Products Administration has issued a notice on the release of the “Guidelines for Filling Out the Annual Work Summary Report of Clinical Trial Institutions.”

2024-01-26

Effective March 1, 2024! The CDE issues a notice announcing the release of documents including the "Technical Requirements for Electronic Disks Containing Submission Materials."

Effective March 1, 2024! The CDE issues a notice announcing the release of documents including the "Technical Requirements for Electronic Disks Containing Submission Materials."

2023-12-25

Breaking News! The Center for Drug Evaluation of the National Medical Products Administration has issued the Notice on the Publication of the “Technical Guidance Principles for Clinical Safety Evaluation of New Drugs” (No. 59 of 2023).

Breaking News! The Center for Drug Evaluation of the National Medical Products Administration has issued the Notice on the Publication of the “Technical Guidance Principles for Clinical Safety Evaluation of New Drugs” (No. 59 of 2023).

2023-12-25

Big News! The National Medical Products Administration’s Center for Drug Evaluation has issued a notice on the promulgation of the “Procedures for Safety Information Assessment and Risk Management during Clinical Trials of Drugs (Trial Implementation)” by the Center for Drug Evaluation.

Big News! The National Medical Products Administration’s Center for Drug Evaluation has issued a notice on the promulgation of the “Procedures for Safety Information Assessment and Risk Management during Clinical Trials of Drugs (Trial Implementation)” by the Center for Drug Evaluation.

2023-11-24

Effective March 12, 2024! Announcement by the National Medical Products Administration and the National Health Commission on the Release and Implementation of the First Supplementary Volume to the Pharmacopoeia of the People’s Republic of China (2020 Edition)

Effective March 12, 2024! Announcement by the National Medical Products Administration and the National Health Commission on the Release and Implementation of the First Supplementary Volume to the Pharmacopoeia of the People’s Republic of China (2020 Edition)

2023-10-25

Big News! 2022 Annual Drug Review Report

Big News! 2022 Annual Drug Review Report

2023-09-22

Big News! The Center for Drug Evaluation of the National Medical Products Administration has released the “Annual Report on the Progress of Clinical Trials for New Drug Registration in China (2022).”

Big News! The Center for Drug Evaluation of the National Medical Products Administration has released the “Annual Report on the Progress of Clinical Trials for New Drug Registration in China (2022).”

2023-09-22

Big News! The CDE Releases a Trio of Guiding Principles for Drug Development “Patient-Centric”!!!

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).

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