Three consecutive shots! CDE Release Guidelines

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Author：Clinical Research Association Time：2025-04-02 Reader：27

With the revision of laws and regulations such as the Vaccine Management Law, Drug Management Law, and Drug Registration Management Measures, the application of new technologies and methods in the vaccine field, and the continuous development of regulatory science, in order to better adapt to the current clinical research and evaluation needs of vaccines, under the deployment of the National Medical Products Administration, the Drug Evaluation Center organized the revision of the "Technical Guidelines for Vaccine Clinical Trials" released in 2004 (see attachment). According to the Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Procedure for Issuing Drug Technical Guidance Principles (Drug Administration Comprehensive Drug Administration [2020] No. 9), and with the review and approval of the National Medical Products Administration, it is now issued and shall come into effect from the date of issuance. The original "Technical Guidelines for Vaccine Clinical Trials" are simultaneously abolished.

This is to inform you.Attachment: Technical Guidelines for Vaccine Clinical Trials

National Medical Products Administration Drug Review Center

March 24, 2025

The technical specification document of ICH "M11: Electronic Structured Coordinated Clinical Protocol" has now entered the third stage of regional public solicitation for opinions. According to the relevant regulations of ICH, members of the regulatory body of ICH are required to collect local opinions on the draft document and provide feedback to ICH.

The original English text and Chinese translation of the draft M11 technical specification document are attached. We are now soliciting public opinions on the content and Chinese translation of the guiding principles.

If there are any relevant suggestions from all sectors of society, please provide feedback to our center via email before April 28, 2025.

Email: gkzhqyj@cde.org.cn

Attachment: 1. [English] M11 Technical Specification Document (Draft)

2. [Chinese] M11 Technical Specification Document (Draft)

National Medical Products Administration Drug Evaluation Center

March 31, 2025

Our center will hold the fourth "Drug Review Cloud Classroom" in 2025 from 13:30 to 16:30 on April 11th. This course focuses on interpreting the key points related to changes during drug development. The relevant matters are hereby notified as follows:

1、 Training Content

（1） 'Change' has always been a topic of concern for applicants in the drug review cloud classroom. The 2024 Drug Review Cloud Classroom, with the theme of "Change", introduced the contents of "Technical Guidelines for Clinical Changes of Listed Chemical Drugs and Biological Products", "Management of Changes during Clinical Trials and Reflections on Protocol Changes during Drug Clinical Trials", "Technical Guidelines for Pharmaceutical Research and Changes of Biological Products during Clinical Trials", and "Non clinical Research and Evaluation Focus on Changes after Drug Listing".

In order to improve the course system of the Drug Review Cloud Classroom and further expand the theme courses related to "changes", this issue intends to use "Overall Considerations for Drug Changes" as the outline, outlining the overall considerations and basic logic of changes, and supplementing the existing course system with non clinical research related to pharmaceutical changes during the clinical period of chemical drugs and changes during the clinical period of biological products.

On this basis, the requirements for the application materials for the registration of drugs produced overseas and transferred to domestic production (preventive biological products) and the requirements for the application materials for the registration of drugs produced overseas and transferred to domestic production (therapeutic biological products) that have been released will be interpreted.

（2） Q&A Interaction: During the early stage of the training, you can log in to the "Drug Review Cloud Classroom Platform" - "Cloud Classroom Questions and Interaction" to ask questions about the corresponding topics. During the training process, timely question collection will also be conducted in the live interactive area, and common questions will be answered in the Q&A session.

2、 Training time

April 11, 2025, 13:30-16:30

3、 Training methods

（1） Using online platforms for live streaming.

（2） You can click on the "Drug Review Cloud Classroom Live Streaming Entrance" on the Drug Review Cloud Classroom platform to watch.

4、 Participants

The training is open to the whole society, and registration and R&D personnel from drug regulatory agencies, research and development enterprises, and drug production enterprises are welcome to participate.

5、 Register and Register

（1） This training is free of charge, participants can scan the QR code to register.

QR code:

Registration link: https://urlisqvzb.vzan.com/live/page/1029882107?v=1742110543634

（2） Please register and submit questions related to this course for participants in the training.

（3） Welcome to submit training needs and topic suggestions through the "Cloud Classroom Questioning and Interaction" platform of the Drug Review Cloud Classroom.

Attachment: Training Schedule for the Fourth "Drug Review Cloud Classroom" in 2025

2. Online registration and viewing process

National Medical Products Administration Drug Evaluation Center

March 31, 2025

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