Notice on the Public Solicitation of Opinions on the Technical Guidelines for Clinical Trials of Generic Drugs of Oral Inhalation Preparations That Have Been Marketed Abroad and Domestically Unmarketed (Draft for Public Comment)

In order to further guide the scientific and reasonable development of generic drugs for oral inhalation preparations, our center has organized and drafted the "Technical Guidelines for Clinical Trials of Generic Drugs for Oral Inhalation Preparations that have been Marketed Abroad and Domestically Unmarketed

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: Sun Yanzhe

Contact: sunyzh@cde.

Thank you for your participation and great support

Drug Evaluation Center of the State Drug Administration

August 17, 2021

attachment1 :	"Technical Guidelines for Clinical Trials of Generic Drugs of Oral Inhalation Formulations that are Listed Abroad and Not Listed in China (Draft for Public Comment)". pdf
Annex 2:	"Guidelines for the clinical trials of generic drugs for oral inhalation preparations that have been marketed overseas and have not been marketed in China (draft for public comment)" drafting instructions. docx
Annex 3 :	"Technical Guidelines for Clinical Trials of Generic Drugs of Oral Inhalation Formulations (Draft for Public Comment) that have been marketed overseas and have not been marketed in China" Opinion Feedback Form. docx

Attachment 1:
"Technical Guidelines for the Clinical Trial of Generic Drugs for Oral Inhalation Formulations Listed Abroad and Domestically Unmarketed (Draft for Public Comment)".
pdf
Appendix 2:
"Technical Guidelines for the Clinical Trial of Generic Drugs for Overseas Listed and Unmarketed Oral Inhalation Preparations in China "Principles (Draft for Public Comment)" drafting instructions.
docx
Annex 3:
"Technical Guidelines for Clinical Trials of Generic Drugs for Oral Inhalation in Domestic Markets and Unmarketed Overseas Markets (Draft for Public Comment)" feedback form.
docx
Annex 1:
"Overseas Technical Guidelines for the Clinical Trials of Generic Drugs of Listed Domestic and Unmarketed Oral Inhalation Preparations (Draft for Public Comment).
pdf
Annex 1:
"Technical Guidelines for Clinical Trials of Generic Drugs for Overseas Marketed and Unmarketed Oral Inhalation Preparations (for Public Comment) "Draft)".
pdf "Technical Guidelines for Clinical Trials of Generic Drugs of Oral Inhalation Preparations Listed Abroad and Domestically Unmarketed (Draft for Public Comment)".
pdf
Annex 2:
"Clinical Trials of Generic Drugs of Overseas Listed and Unmarketed Oral Inhalation Preparations in China ".
technical guidelines (draft for public Comment) ".
docx drafting notes
Appendix 2: "
listed overseas territory of unlisted oral inhalation drug formulation of generic guidelines for clinical trial technology (draft for public Comment) "drafting notes .
docx " overseas listed Technical Guidelines for Clinical Trials of Generic Drugs for Oral Inhalation Preparations Not on the Market in China (Draft for Public Comment)" Drafting Instructions.
docx
Annex 3:
"Technical Guidelines for the Clinical Trials of Generic Drugs of Oral Inhalation Formulations Listed Abroad and Domestically Unmarketed (Draft for Public Comment)" feedback form.
docx
Annex 3:
"Technical Guidance for Clinical Trials of Generic Drugs of Oral Inhalation Formulations Listed Abroad and Domestically Unmarketed "Principles (Draft for Public Comment)" Feedback Form.
docx "Technical Guidelines for Clinical Trials of Generic Drugs for Oral Inhalation Formulations that have been Marketed Abroad and Domestically Unmarketed (Draft for Public Comment)" Feedback Form.
docx