CDE is publicly soliciting comments on the Guidelines for Natural History Research of Diseases in Drug Development for Rare Diseases

In-depth research and comprehensive understanding of the natural history of diseases is the basis for human understanding of diseases, diagnosis, treatment and drug research and development of
diseases.
In recent years, with the increasing enthusiasm of the pharmaceutical industry for the research and development of drugs for the treatment of rare diseases, the study of the natural history of rare diseases is particularly important
.

In order to promote and standardize the natural history research of rare diseases in China, the relevant indication group of the Drug Review Center organized and wrote the "Guidelines for Natural History Research of Diseases in the Development of Rare Disease Drugs (Draft for Comments)
".
This guideline aims to put forward the key
points of natural history research on diseases in the development of rare disease drugs in line with China's national conditions based on the current status of rare disease research in China.

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.

Your feedback should be sent to the email address of the following contact person:

Contact: Tang Ling, Zhao Boyuan

Contact: tangl@cde.
org.
cn, zhaoby@cde.
org.
cn

Thank you for your participation and great support
.

Center for Drug Evaluation, State Medical Products Administration

December 21, 2022

Related attachments

1.
Annex 1 "Guidelines for Natural History Research of Diseases in the Development of Rare Disease Drugs (Draft for Comments)".
.
pdf

2.
Annex 2 "Guidelines for Natural History Research of Diseases in the Development of Rare Disease Drugs (Draft for Comments)" feedback form .
docx

3.
Annex 3 Guidelines for Natural History Research of Diseases in the Development of Rare Disease Drugs (Draft for Comments) .
pdf Drafting Notes