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Notice on Public Comment on "Guiding Principles for Comprehensive Analysis of Effectiveness of Drug Clinical Research (Draft for Comment)"

 Last Update: 2021-09-20
 Source: Internet
 Author: User

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In accordance with the requirements of ICH M4 Common Technical Document (CTD), in order to guide sponsors to conduct comprehensive analysis of the effectiveness of drug clinical research, so as to show the effectiveness characteristics of drugs as comprehensively and systematically as possible, the Center for Drug Evaluation organized the drafting of the "Effective Drug Clinical Research" Guiding Principles for Comprehensive Analysis of Sexuality (Draft for Solicitation of Comments)", now open for comment

The time limit for soliciting opinions is 1 month from the date of publication

Please send your feedback to the mailbox: Tang Zhimin tangzhm@cde.

Thank you for your participation and great support

Drug Evaluation Center of the State Drug Administration

September 8 2021

attachment1 :	"Guiding Principles for Comprehensive Analysis of Effectiveness of Drug Clinical Research (Draft for Soliciting Comments)". pdf
Annex 2:	"Guiding Principles for Comprehensive Analysis of Effectiveness of Drug Clinical Research (Draft for Solicitation of Comments)" Drafting Instructions. pdf
Annex 3 :	"Guiding Principles for Comprehensive Analysis of Effectiveness of Drug Clinical Research (Draft for Solicitation of Comments)" feedback form for soliciting opinions. docx

Attachment 1:
"Guiding Principles for Comprehensive Analysis of Drug Clinical Research Effectiveness (Draft for Comment)".
pdf
Appendix 2:
"Guiding Principles for Comprehensive Analysis of Drug Clinical Research Effectiveness (Draft for Comment)" Drafting Instructions.
pdf
Attachment 3:
"Clinical Medicines Guiding Principles for Comprehensive Analysis of Research Effectiveness (Consultation Draft)" Feedback Form for Solicitation of Comments.
docx
Attachment 1:
"Guiding Principles for Comprehensive Analysis of Drug Clinical Research Effectiveness (Consultation Draft)".
pdf
Annex 1:
"Comprehensive Drug Clinical Research Effectiveness" Analysis Guiding Principles (Draft for Comment).
pdf "Guiding Principles for Comprehensive Analysis of Drug Clinical Research Effectiveness (Consultation Draft)".
pdf
Annex 2:
"Guiding Principles for Comprehensive Analysis of Drug Clinical Research Effectiveness (Draft for Comment)" drafting instructions .
pdf
Attachment 2:
"Guidelines for Comprehensive Analysis of Drug Clinical Research Effectiveness (Draft for Comment)" drafting instructions.
pdf "Guidelines for Comprehensive Analysis of Drug Clinical Research Effectiveness (Draft for Comment)" Drafting Instructions.
pdf
Attachment 3:
"Drugs "Guiding Principles for Comprehensive Analysis of Clinical Research Effectiveness (Draft for Comment)" Soliciting Comments and Feedback Form.
docx
Attachment 3:
"Guiding Principles for Comprehensive Analysis of Effectiveness of Drug Clinical Research (Draft for Comments)" Soliciting Feedback Form.
docx "Guiding Principles for Comprehensive Analysis of Effectiveness of Drug Clinical Research (Draft for Solicitation of Comments)" feedback form for soliciting opinions.
docx

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