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Since the official release of the "Technical Guidelines for Clinical Trials of Improved New Drugs of Chemical Drugs" in December 2020, the communication and exchange of clinical research and development of improved new drugs has gradually increased.
In order to further promote the orderly research and development of improved new drugs in China and better meet the clinical needs of patients , the guiding principle working group has systematically sorted out and discussed the relatively concentrated common issues, and formed the "<Technical Guiding Principles for Clinical Trials of Improved New Drugs of Chemical Drugs> Questions and Answers (Draft for Comment)"
.
We sincerely welcome valuable comments and suggestions from all walks of life on the draft, and timely feedback to us for subsequent improvement
.
The time limit for soliciting comments is one month from the date of publication
.
Please send your feedback to the following email addresses:
Contact: Song Yuanyuan, Ai Xing
Contact: songyy@cde.
org.
Thank you for your participation and great support
Center for Drug Evaluation, State Drug Administration
March 14, 2022
Relevant attachments
serial number | accessory name |
---|---|
1 | Questions and Answers on Technical Guidelines for Clinical Trials of Improved New Drugs of Chemical Drugs (Draft for Comments). |
2 | Drafting Instructions for "Questions and Answers on Technical Guiding Principles for Clinical Trials of Improved New Drugs of Chemical Drugs (Draft for Comment)". |
3 | Questions and Answers on Technical Guiding Principles for Clinical Trials of Improved New Drugs of Chemical Drugs (Draft for Comment) Feedback Form. docx |