Statistical Guidelines for Clinical Research of Rare Disease Drugs (Draft for Solicitation of Comments) released

On November 18th, CDE drafted the "Guiding Principles for Clinical Research of Rare Disease Drugs (Draft for Comment)", which is now open for comment
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The original text is as follows: In order to encourage pharmaceutical companies to develop rare disease treatment drugs and improve the efficiency and quality of clinical research and development, our center organized the drafting of the "Rare Disease Drug Clinical Research Statistical Guidelines (Draft for Comment)", which is now open for comments
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We welcome valuable comments and suggestions from all walks of life, and please give us feedback in time
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The time limit for soliciting opinions is 1 month from the date of publication
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Please send your feedback to the mailbox: Heng Mingli hengml@cde.
org.
cn; Sun Fengyu sunfengyu@cde.
org.
cn Thank you for your participation and strong support
.
Drug Evaluation Center of the National Medical Products Administration November 18, 2021 Annex 1.
"Guiding Principles for Clinical Research of Rare Disease Drugs (Draft for Comment)" Drafting Notes 2.
"Guiding Principles for Clinical Research of Rare Disease Drugs (for Solicitation) Opinion Draft) 3.
“Guidelines for Statistics of Clinical Research on Rare Disease Drugs (Draft for Comment)” feedback form for soliciting opinions