Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello All,

Does anyone know if a DMF can be used to submit proprietary nonclinical data to NMPA to support another sponsor's drug application in China?  I know NMPA accepts DMFs for APIs, packaging materials, excipients and medical devices but have found no information on the acceptability of submitting other types of proprietary information in a DMF to the Chinese regulatory authority.  Is there a  Chinese equivalent to the U.S. Type V DMF?  

Or, if a DMF is not viable for this purpose, is there another way to submit proprietary nonclinical data to NMPA?

Any feedback would be greatly appreciated!

Thank you

Dear Anonymous,

Did you receive appropriate and helpful responses by the time?
If you want to discuss this further, you can contact me directly.

Best regards,
Markus

------------------------------
Markus Roepke
Business Development D/A/CH
Cisema GmbH
Munich Area
Germany
roepke@cisema.de
------------------------------

Original Message:
Sent: 16-Sep-2020 18:58
From: Anonymous Member
Subject: Confidential nonclinical data submission to NMPA (China)

This message was posted by a user wishing to remain anonymous

Hello All,

Does anyone know if a DMF can be used to submit proprietary nonclinical data to NMPA to support another sponsor's drug application in China?  I know NMPA accepts DMFs for APIs, packaging materials, excipients and medical devices but have found no information on the acceptability of submitting other types of proprietary information in a DMF to the Chinese regulatory authority.  Is there a  Chinese equivalent to the U.S. Type V DMF?

Or, if a DMF is not viable for this purpose, is there another way to submit proprietary nonclinical data to NMPA?

Any feedback would be greatly appreciated!

Thank you