Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

For one of our product that will need to be re-registered in China, the authorities are requesting to provide additional clinical data in the meantime. As we have now a clinical plan, we would like to request feedback from the NMPA on this plan. Are you aware of a specific pathway to collect their input? Similarly to FDA meetings or EMA Scientific Advice. Is there any timelines to submit such request?

Thank you for your help,

Kind Regards

Hi there,

Contacting the NMPA is THE job of your local NMPA Legal Agent. He should have the expertise not only in preparing standard registrations, but also deal with special requests. Recently the NMPA organized the drafting of "Measures for the Supervision and Administration of Imported Medical Device Agents" which includes much more responsibilities than in the past, focus on PMS. You might want to think about the qualifications of your NMPA Legal Agent. We offer all services around registration, NMPA representation and clinical trials. 
I hope this helps.

Best regards from Munich area,

Markus

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Markus Roepke
Planegg
Germany
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Original Message:
Sent: 03-Mar-2021 18:09
From: Anonymous Member
Subject: China - Collect NMPA feedback

This message was posted by a user wishing to remain anonymous

Hello,

For one of our product that will need to be re-registered in China, the authorities are requesting to provide additional clinical data in the meantime. As we have now a clinical plan, we would like to request feedback from the NMPA on this plan. Are you aware of a specific pathway to collect their input? Similarly to FDA meetings or EMA Scientific Advice. Is there any timelines to submit such request?

Thank you for your help,

Kind Regards

Typically, one year from the Inquiry issue date is the timeline for responding the NMPA inquiry for License Extension.
At the same time, you will need Local legal representative to set up the consultation session to discuss the matter if it is needed.  

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YING LI
Bloomington IN
United States
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Original Message:
Sent: 03-Mar-2021 18:09
From: Anonymous Member
Subject: China - Collect NMPA feedback

This message was posted by a user wishing to remain anonymous

Hello,

For one of our product that will need to be re-registered in China, the authorities are requesting to provide additional clinical data in the meantime. As we have now a clinical plan, we would like to request feedback from the NMPA on this plan. Are you aware of a specific pathway to collect their input? Similarly to FDA meetings or EMA Scientific Advice. Is there any timelines to submit such request?

Thank you for your help,

Kind Regards

Hello,

Similar to FDA meetings and EMA Scientific Advice, China also has such meetings with competent authority - Center for Drug Evaluation (CDE) of NMPA to discuss crucial technical issues.

For your product which needs to be re-registered in China, you can apply for a Pre-IND meeting with CDE for their opinions or suggestions on your clinical plan and data. However, in recent time, due to COVID-19 pandemic, online meeting is taking the place of face-to-face meeting. It is also possible when CDE determines it is not necessary to hold a meeting to solve applicant's questions, they give their writing answers instead of holding a meeting.

Generally, it will take around several days for project management personnel of CDE to preliminarily review the application materials and check if additional materials is required, and then for professional reviewers to determine whether or not the meeting application is accepted. After conformation of meeting, it is around 2 months from application date to meeting or email communication if everything goes very smoothly, but some times it may need another 1-3 months or even more time to queue for the meeting.

Hope my answer helps. If more detailed information about communication or meeting with CDE (e.g. the procedure, requirements, timelines etc.) is required, more than happy to help.

Kind Regards
Raymond

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Raymond Ng
China Regulatory Affairs
Accestra Consulting
China Regulatory Outsourcing for Food & Drug for NMPA/CFDA registration of China Drug: NDA/IND/DMF/APIs www.accestra.com
------------------------------

Original Message:
Sent: 03-Mar-2021 18:09
From: Anonymous Member
Subject: China - Collect NMPA feedback

This message was posted by a user wishing to remain anonymous

Hello,

For one of our product that will need to be re-registered in China, the authorities are requesting to provide additional clinical data in the meantime. As we have now a clinical plan, we would like to request feedback from the NMPA on this plan. Are you aware of a specific pathway to collect their input? Similarly to FDA meetings or EMA Scientific Advice. Is there any timelines to submit such request?

Thank you for your help,

Kind Regards