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Author： Medical Expo Time：2025-05-23 Reader：78

1. Notice on Matters Related to Communication and Exchange Services for Listing, Registration and Registration of Traditional Oral traditional Chinese patent medicines and simple preparations Listed in Hong Kong and Macao on the Mainland

In order to effectively promote the process of listing and registration of traditional oral traditional Chinese patent medicines and simple preparations that has been listed in Hong Kong and Macao on the mainland, the applicant can propose communication or consultation as required from May 19, 2025, before the submission of the application for listing license of traditional oral traditional Chinese patent medicines and simple preparations that has been listed in Hong Kong and Macao on the mainland, upon the approval of the State Drug Administration. The specific requirements are hereby notified as follows:

1、 For communication and exchange situations that meet the requirements of the "Management Measures for Communication and Exchange in Drug Development and Technical Review", applicants can submit Class I meeting applications. The meeting materials submitted by the applicant shall comply with the requirements of Simplifying the Application Materials and Technical Requirements for the Approval of the Listing of Traditional Oral traditional Chinese patent medicines and simple preparations in Hong Kong and Macao on the Mainland. The Drug Evaluation and Inspection Dawan Branch Center (hereinafter referred to as the Drug Dawan Branch Center) shall organize the acceptance and review team to complete the communication and exchange review within 30 working days.

2、 For other situations that require communication and exchange, the applicant can consult through relevant pre - and in person communication channels of the Greater Bay Area Center for Drugs. The Greater Bay Area Center for Drugs will provide guidance and services according to the application path and time limit requirements.

National Medical Products Administration Drug Evaluation Center

National Medical Products Administration Drug Evaluation and Inspection Center of Greater Bay Area

May 19, 2025

Original link:：

https://www.cde.org.cn/main/news/viewInfoCommon/71f5eb84dc07225f27a7908db24c3f02

2. Notice on Publicly Soliciting Opinions on the "Catalogue of Reference Preparations for Chemical Generic Drugs (94th Batch)" (Draft for Comments)

According to the Announcement on the Selection and Determination Procedure of Reference Formulations for Chemical Generic Drugs (No. 25 of 2019) issued by the National Bureau on March 28, 2019, our center has organized the selection of the 94th batch of reference formulations (see attachment) and is now publicly soliciting opinions.

During the public announcement period, please provide feedback to the drug review center through the "Application for Suspected Varieties of Reference Preparations" module on the reference preparation selection application platform. In order to better serve applicants, please provide sufficient evidence and supporting materials for feedback. The feedback materials should be stamped with the official seal of the unit and provide real names and contact information.

Publicity period: May 19, 2025 to May 30, 2025 (10 working days).

National Medical Products Administration Drug Evaluation Center

2025年5月19日

Original link:：

https://www.cde.org.cn/main/news/viewInfoCommon/dca68f17e87da392efdc6a41bb2d2ba2

3. Notice on the Public Solicitation of Opinions on the General Principles and Considerations for Adaptive Aging Design in Innovative Drug Development (Draft for Comments)

In order to implement the requirements of ICH E7, promote the development of innovative drugs to better meet the clinical needs of elderly patients, improve medication experience, reduce medication errors, and enhance overall health, our center has organized the drafting of the "General Principles and Considerations for Age Appropriate Design in Innovative Drug Development" (draft for comments).

We sincerely welcome valuable opinions and suggestions from all sectors of society on the draft for soliciting opinions, and provide timely feedback to us for future improvement. The deadline for soliciting opinions is one month from the date of publication.

Please send your feedback to the email address of the following contact person:

Contact persons: Geng Ying, Cong Duandan

contact information: congdd@cde.org.cn

Thank you for your participation and strong support.

National Medical Products Administration Drug Evaluation Center

May 19, 2025

Original link:

https://www.cde.org.cn/main/news/viewInfoCommon/5cd93ac7ac1bbadb4775c3a00695f252

4. Notice on Soliciting Opinions on the Key Points for Writing Medication Information for the Elderly in Drug Instructions (Draft for Comments)

In order to promote the orderly drafting and improvement of medication information for the elderly population in drug instructions by enterprises, and better guide clinical rational drug use, our center has organized the drafting of the "Key Points for Writing Medication Information for the Elderly Population in Drug Instructions" (draft for comments).

Please send your feedback to the email address of the following contact person:

Contact persons: Geng Ying, Cong Duandan

contact information: congdd@cde.org.cn

Thank you for your participation and strong support.

National Medical Products Administration Drug Evaluation Center

May 19, 2025

Original link:

https://www.cde.org.cn/main/news/viewInfoCommon/15ecc3abc2c5d934ebe7cd14300b68bd

5. Notice on the Public Solicitation of Opinions on the Key Elements and Trial Design Points of Elderly People's Participation in Innovative Drug Clinical Trials (Draft for Comments)

In order to better implement the requirements of ICH E7 guidelines, promote the standardized development of clinical trials for the elderly population in innovative drug research and development in China, clarify the key elements of clinical trial design for the elderly population, and improve the scientific and reliable nature of research data, our center has organized the drafting of the "Key Elements and Trial Design Points for the Elderly Population to Participate in Innovative Drug Clinical Trials" (draft for comments).

Please send your feedback to the email address of the following contact person:

Contact persons: Geng Ying, Cong Duandan

contact information: congdd@cde.org.cn

Thank you for your participation and strong support.

National Medical Products Administration Drug Evaluation Center

May 19, 2025

Original link:

https://www.cde.org.cn/main/news/viewInfoCommon/183e1d1a1afabb59973634b1aa791b02

Source: Official website of the Drug Evaluation Center of the National Medical Products Administration

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