Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello ,

Advice on China filings ..

We have received the supplementary notice for our submission , however the findings relate to technical  differences (based on testing) between the approved products and the products in the change application; which we had already explained in the Clinical Evaluation Report (comparative table). What does the NMPA expect to see during such situations ? Is it true they provide just 3 chances to check with the reviewer before submitting the response and that there's no 3 rd round of review , the submission gets rejected , if the response is not satisfactory ?

China supplemental notice allows three +1 live discussion sessions before your final submission.  This is a very common process of negotiating with the technical and clinical reviewers about the deficiency areas.  Two different departments and two different reviewers: technical review and clinical review.  Technical differences justification need to be reflected in both the technical side as well as the CER side.  Typically CER side of the technical comparison is based on off the PTR and product working mechanism on the technical side of the documentation.  I am NOT surprised that you got this question you are only replying on your CER side to explain the differences.  Sometimes the deficiency areas could be due to mis-understanding.  Typically we review the supplement areas ourselves to see why the reviewers ask those questions.  Then we have calls with our clients, the manufacturers, to discuss out thoughts and reach agreement.  Then we schedule a call with the reviewer to clarify and negotiate what we must do or not do to address the deficiency areas.  I made some general comments as I do not know your product details and its classification and registration pathway. 
Please feel free to email me gpalma@ChinaMedDevice.com  if you like to discuss further.

------------------------------
Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com
978-390-4453
www.ChinaMedDevice.com
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Original Message:
Sent: 30-Mar-2022 19:45
From: Anonymous Member
Subject: China Supplementary notice response

This message was posted by a user wishing to remain anonymous

Hello ,

Advice on China filings ..

We have received the supplementary notice for our submission , however the findings relate to technical  differences (based on testing) between the approved products and the products in the change application; which we had already explained in the Clinical Evaluation Report (comparative table). What does the NMPA expect to see during such situations ? Is it true they provide just 3 chances to check with the reviewer before submitting the response and that there's no 3 rd round of review , the submission gets rejected , if the response is not satisfactory ?

Hi Anon,

It sounds like a matter of clarification and further explanation/supplementation of the CER. It is almost a matter of course for submissions to receive a supplementary notice seeking further questions, so this itself shouldn't be a cause for alarm. 

Yes, there is only 1 formal supplementary notice issued. So if your formal response is not satisfactory, you won't get another chance.  Having said this, there is plenty of opportunity for more informal dialogue and communications with the assigned NMPA reviewer (although, as you say, only 3 meetings) prior to your formal supplementary notice reply so the likely outcome shouldn't be a surprise. Therefore, management of this supplementary notice process is key. 

Regards
Hamish

------------------------------
Hamish King
hamish.king@cisema.com
www.cisema.com
------------------------------

Original Message:
Sent: 30-Mar-2022 19:45
From: Anonymous Member
Subject: China Supplementary notice response

This message was posted by a user wishing to remain anonymous

Hello ,

Advice on China filings ..

We have received the supplementary notice for our submission , however the findings relate to technical  differences (based on testing) between the approved products and the products in the change application; which we had already explained in the Clinical Evaluation Report (comparative table). What does the NMPA expect to see during such situations ? Is it true they provide just 3 chances to check with the reviewer before submitting the response and that there's no 3 rd round of review , the submission gets rejected , if the response is not satisfactory ?