CDE issued the "Technical Guidelines for Clinical R&D of New Chinese Medicine Compound Preparations Related to the Treatment of Malignant Tumors" (Zheng)

On November 17, CDE issued the "Technical Guidelines for Clinical R&D of New Chinese Medicine Compound Preparations Related to the Treatment of Malignant Tumors (Draft for Comments)"
.
The guiding principles mention that traditional Chinese medicine is an important part of the treatment of malignant tumors, and has a certain role or unique advantage
in controlling the development of some tumor patients and improving tumor complications and their associated symptoms.
Under the evidence system for registration review of Chinese medicines combining Chinese medicine theory, human experience and clinical trials ("three-combination" registration review evidence system), these guidelines focus on the clinical application status of Chinese medicine compound preparations for malignant tumors, Chinese medicine theory, and general considerations
for human experience research and clinical trials.

In order to promote the construction of a Chinese medicine registration review evidence system combining Chinese medicine theory, human use experience and clinical trials, and guide applicants to develop Chinese medicine new drug compound preparations related to the treatment of malignant tumors that meet the advantages and characteristics of Chinese medicine treatment and are related to the treatment of malignant tumors in accordance with the "three combinations" registration review evidence system, the Center for Drug Review drafted the "Technical Guidelines for Clinical Research and Development of New Chinese Medicine Compound Preparations Related to the Treatment of Malignant Tumors (Draft for Comments)", which has been discussed within the Center and organized by academic experts, and has formed a draft for comments
。 The Centre's website is now available for a wide range of opinions and suggestions
.

We sincerely welcome all sectors of the community to put forward valuable comments and suggestions on the draft for comments, and feedback to us in time for subsequent improvement
.
The time limit for soliciting comments is 1 month
from the date of publication.

Contact: Xue Feiran xuefr@cde.
org.
cn, Anna anna@cde.
org.
cn
.

Thank you for your great support!

Center for Drug Evaluation

November 17, 2022

Related attachments

1 "Technical Guidelines for Clinical R&D of New Chinese Medicine Compound Preparations Related to the Treatment of Malignant Tumors (Draft for Comments)".
.
pdf