CDE publicly solicits opinions on 2 technical guidelines

On October 11, the CDE official website publicly solicited opinions on two technical guidelines, namely, the technical guidelines for the clinical research and development of rare disease drugs and the technical guidelines for the design of long-acting granulocyte colony stimulating factors to prevent infection after chemotherapy (draft for comments)

The details are as follows:

Notice on Public Solicitation of Opinions on the "Technical Guidelines for the Clinical Research and Development of Rare Disease Drugs"

Rare disease is a collective term for a group of diseases with extremely low incidence.

In order to further improve the efficiency of clinical research and development of rare diseases, meet the treatment needs of patients with rare diseases, combine the characteristics of rare diseases, and provide suggestions and references for the research and development of rare disease drugs and scientific trial design, the Center for Drug Evaluation organized and wrote the "Clinical Research and Development of Rare Disease Drugs" "Technical Guiding Principles" to form a 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

Please send your feedback to the mailbox of the following contact:

Contacts: Zhao Boyuan, Tang Ling, Zhang Jie

Contact: zhaoby@cde.

Thank you for your participation and great support

Drug Evaluation Center

October 11, 2021

Attachment "Technical Guidelines for the Clinical Research and Development of Rare Disease Drugs (Draft for Solicitation of Comments)"

Notice on Publicly Soliciting Opinions on the "Technical Guidelines for the Design of Clinical Trials of Long-acting Granulocyte Colony Stimulating Factor Preventing Infection after Chemotherapy (Draft for Solicitation of Comments)"

Neutropenia is a hematological toxicity related to bone marrow suppression caused by chemotherapy.

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

Please send your feedback to the mailbox of the following contact:

Contact: Zhang Hong

Contact: zhanghong@cde.

Thank you for your participation and great support

Drug Evaluation Center

October 11, 2021

Attachment "Technical Guidelines for the Design of Clinical Trials of Long-acting Granulocyte Colony Stimulating Factor to Prevent Infection After Chemotherapy (Draft for Solicitation of Comments)"