In order to increase the guidance and services of the applicant, further improve the quality and efficiency of the application of electronic declaration materials for drug registration, standardize the management of electronic declaration data, actively promote the implementation of the new version of the electronic application requirements, and strengthen the applicant's chemistry The understanding of the relevant technical requirements of the pharmaceutical changes in biological products and concentrated on answering related commonality and common questions. The pharmaceutical review center planned to organize the training of "electronic declaration and pharmaceutical changes" training on February 2, 2024.

The relevant matters are notified as follows:
       1. Meeting time
      February 2, 2024, 13: 30-17: 00
       2. Meeting method
       Use online platforms for online live broadcast.
       3. Participants
     The training is open to the whole society. Related personnel from R & D enterprises and pharmaceutical manufacturers are welcome to participate.
       Fourth, the main content
       New requirements and common issues around the application of electronic application for drug registration, the introduction of electronic application data production data production software, drug registration application data receiving relevant requirements and precautions, "M4 module one administrative documents and drug information" basic requirements Frequently issues, common issues for chemical pharmaceutical supplementary applications, and sharing the principles of technical guidance in biological product pharmacy and change during clinical trials. For details, please refer to the training agenda.
       5. Registration and registration
     This training does not charge fees, and the participants scan the QR code to enter the registration.
       Register to watch the QR code:

Live link:

>>> https://wx.vzan.com/live/page/1739645125?v=1706002256274 <<<<

Part of the content is quoted from:
https://www.cde.org.cn/main/newinfocommon/471FB635EF089D79D3DA2AF083482E