CDE publicly solicits opinions on two research technical guidelines

From October 12th to 13th, the CDE official website issued a notice on the public solicitation of two research technical guidelines, namely the "Guiding Principles for Toxicology Research on Ancient Classical Chinese Medicine Compound Preparations" and "Technical Guidelines for Clinical Research on Rabies Vaccines for Human Use" Principles (Draft for Comment)
.
The details are as follows: Notice on the public solicitation of "Guiding Principles for Toxicological Research on Traditional Chinese Medicine Compound Preparations of Ancient Classical Prescriptions" Date of publication: 20211012 In order to strengthen the combing and excavation of the essence of classical medical books, reform and improve the review and approval mechanism of Chinese medicines, and promote new Chinese medicines For R&D and industrial development, the "Registration Classification and Application Information Requirements of Chinese Medicines" (Announcement No.
68, 2020 of the National Bureau) subdivided the third type of ancient classic Chinese medicine compound preparations in the classification of Chinese medicine registration into "3.
1 According to ancient classics "Catalogue management of Chinese medicine compound preparations (referred to as category 3.
1)" and "3.
2 other traditional Chinese medicine compound preparations from ancient classic prescriptions (referred to as category 3.
2)"
.
These two types of preparations need to provide non-clinical safety evaluation data
.
In order to guide and standardize the development and evaluation of ancient classic Chinese medicine compound preparations, the Department of Pharmacology and Toxicology initiated the drafting of the "Guidelines for the Toxicology Research Technology of Ancient Classic Chinese Medicine Compound Preparations" in 2021
.
In accordance with the procedures for the formulation and revision of the central guidelines, the working group of the guidelines has been discussed for many times, and the expert seminars on the guidelines have been convened.
Publicly solicit opinions and suggestions
.
We sincerely hope that all sectors of the society will put forward valuable comments on the draft for comments and provide timely feedback to us for follow-up improvement
.
The time limit for soliciting opinions is 1 month from the date of publication
.
Please send your feedback to the mailbox of the following contact: Contact: Huang Fanghua huangfh@cde.
org.
cn, Zhou Zhixing zhouzhx@cde.
org.
cn Attachment: Technical Guidelines for Toxicological Research of Ancient Classical Chinese Medicine Compound Preparations (solicited) Opinion Draft) Notice on the public solicitation of opinions on the "Technical Guidelines for the Clinical Research of Rabies Vaccines for Human Use (Consultation Draft)" Release date: 20211013 To standardize and guide the clinical research and evaluation of rabies vaccines for human use, as a developer and regulatory agency To provide technical reference, our center drafted the "Technical Guidelines for the Clinical Research of Rabies Vaccine for Human Use (Draft for Soliciting Comments)"
.
We sincerely welcome valuable comments and suggestions from all walks of life on the solicitation draft, and timely feedback to us for follow-up improvement
.
The time limit for soliciting opinions is 1 month from the date of publication
.
Please send your feedback to the following contact emails: Contacts: Liu Bo, Deng Xia Email: liub@cde.
org.
cn; dengx@cde.
org.
cn Attachment: Technical Guidelines for Human Rabies Vaccine Clinical Research (soliciting Opinion draft)