Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Does anyone have an idea whether fast track approval  process exists for an equivalent device  with NMPA? Also is there any way , a change application to a product can be submitted prior to the product renewal coming through ?

thnx

Dear Anon

There is a fast-track approval process but in our experience access it is very limited, especially for non-Chinese companies. There was an emergency approval process relating to the Covid pandemic last year, but that is now closed. The innovative pathway is still open, but it does not circumvent the requirement for local testing in China, which is generally the most burdensome aspect of China registration. 

Generally a change application should not be submitted until the product renewal comes through. So your product scope should be fixed prior to China local testing through to certificate issuance.

Best
Hamish

------------------------------
Hamish King
Director Business Development
Hong Kong
hamish.king@cisema.com
------------------------------

Original Message:
Sent: 21-Feb-2021 00:22
From: Anonymous Member
Subject: China - fast track approvals

This message was posted by a user wishing to remain anonymous

Does anyone have an idea whether fast track approval  process exists for an equivalent device  with NMPA? Also is there any way , a change application to a product can be submitted prior to the product renewal coming through ?

thnx

This message was posted by a user wishing to remain anonymous

Hi Hamish ,

Thanks for your feedback, am aware there's not way around local testing , however is there a way , that the NMPA approval timelines can be accelerated ?
Original Message:
Sent: 24-Feb-2021 03:45
From: Hamish King
Subject: China - fast track approvals

Dear Anon

There is a fast-track approval process but in our experience access it is very limited, especially for non-Chinese companies. There was an emergency approval process relating to the Covid pandemic last year, but that is now closed. The innovative pathway is still open, but it does not circumvent the requirement for local testing in China, which is generally the most burdensome aspect of China registration.

Generally a change application should not be submitted until the product renewal comes through. So your product scope should be fixed prior to China local testing through to certificate issuance.

Best
Hamish

------------------------------
Hamish King
Director Business Development
Hong Kong
hamish.king@cisema.com

Original Message:
Sent: 21-Feb-2021 00:22
From: Anonymous Member
Subject: China - fast track approvals

This message was posted by a user wishing to remain anonymous

Does anyone have an idea whether fast track approval  process exists for an equivalent device  with NMPA? Also is there any way , a change application to a product can be submitted prior to the product renewal coming through ?

thnx

Yes, NMPA approval timelines can be accelerated for innovative products from around 9-12 months to 6 or less - but again please note this designation is given very sparingly. Key challenges are: primary working principle of the product is the first in China, and the product has a Chinese patent. 

Between 2014-2020, we know of only 4 non-Chinese companies that were granted innovation status: from Medtronic, Novocure, Edwards LifeSciences and Abbott. I've linked the announcements (Google Translate works fine) to NMPA pages here:
https://www.nmpa.gov.cn/zhuanti/ypqxgg/gggzjzh/20200514152501633.html?type=pc&m=
https://www.nmpa.gov.cn/ylqx/ylqxjgdt/20200608144301692.html 
https://www.nmpa.gov.cn/yaowen/ypjgyw/20200616142801907.html?type=pc&m= 
https://www.cmde.org.cn/directory/web/WS01/images/vq21vLnc1rLI68q9zt61vMfxvCyq8+1zbOjqEpRWjE4MDAzNzKjqS5wZGY=.pdf 

Priority review is another pathway with accelerated approval times. Its focus is rare disease treatments that are urgently needed for clinical use. It is similarly demanding in its requirements.

Hamish King
hamish.king@cisema.com



------------------------------
Hamish King
Director Business Development
Hong Kong
hamish.king@cisema.com
------------------------------

Original Message:
Sent: 27-Feb-2021 22:58
From: Anonymous Member
Subject: China - fast track approvals

This message was posted by a user wishing to remain anonymous

Hi Hamish ,

Thanks for your feedback, am aware there's not way around local testing , however is there a way , that the NMPA approval timelines can be accelerated ?
Original Message:
Sent: 24-Feb-2021 03:45
From: Hamish King
Subject: China - fast track approvals

Dear Anon

There is a fast-track approval process but in our experience access it is very limited, especially for non-Chinese companies. There was an emergency approval process relating to the Covid pandemic last year, but that is now closed. The innovative pathway is still open, but it does not circumvent the requirement for local testing in China, which is generally the most burdensome aspect of China registration.

Generally a change application should not be submitted until the product renewal comes through. So your product scope should be fixed prior to China local testing through to certificate issuance.

Best
Hamish

------------------------------
Hamish King
Director Business Development
Hong Kong
hamish.king@cisema.com

Original Message:
Sent: 21-Feb-2021 00:22
From: Anonymous Member
Subject: China - fast track approvals

This message was posted by a user wishing to remain anonymous

Does anyone have an idea whether fast track approval  process exists for an equivalent device  with NMPA? Also is there any way , a change application to a product can be submitted prior to the product renewal coming through ?

thnx

This message was posted by a user wishing to remain anonymous

thanks Hamish
Original Message:
Sent: 01-Mar-2021 22:59
From: Hamish King
Subject: China - fast track approvals

Yes, NMPA approval timelines can be accelerated for innovative products from around 9-12 months to 6 or less - but again please note this designation is given very sparingly. Key challenges are: primary working principle of the product is the first in China, and the product has a Chinese patent.

Between 2014-2020, we know of only 4 non-Chinese companies that were granted innovation status: from Medtronic, Novocure, Edwards LifeSciences and Abbott. I've linked the announcements (Google Translate works fine) to NMPA pages here:
https://www.nmpa.gov.cn/zhuanti/ypqxgg/gggzjzh/20200514152501633.html?type=pc&m=
https://www.nmpa.gov.cn/ylqx/ylqxjgdt/20200608144301692.html
https://www.nmpa.gov.cn/yaowen/ypjgyw/20200616142801907.html?type=pc&m=
https://www.cmde.org.cn/directory/web/WS01/images/vq21vLnc1rLI68q9zt61vMfxvCyq8+1zbOjqEpRWjE4MDAzNzKjqS5wZGY=.pdf

Priority review is another pathway with accelerated approval times. Its focus is rare disease treatments that are urgently needed for clinical use. It is similarly demanding in its requirements.

Hamish King
hamish.king@cisema.com

Anonymous Member,  27-Feb-2021 22:58

------------------------------
Hamish King
Director Business Development
Hong Kong
hamish.king@cisema.com

Original Message:
Sent: 27-Feb-2021 22:58
From: Anonymous Member
Subject: China - fast track approvals

This message was posted by a user wishing to remain anonymous

Hi Hamish ,

Thanks for your feedback, am aware there's not way around local testing , however is there a way , that the NMPA approval timelines can be accelerated ?
Original Message:
Sent: 24-Feb-2021 03:45
From: Hamish King
Subject: China - fast track approvals

Dear Anon

There is a fast-track approval process but in our experience access it is very limited, especially for non-Chinese companies. There was an emergency approval process relating to the Covid pandemic last year, but that is now closed. The innovative pathway is still open, but it does not circumvent the requirement for local testing in China, which is generally the most burdensome aspect of China registration.

Generally a change application should not be submitted until the product renewal comes through. So your product scope should be fixed prior to China local testing through to certificate issuance.

Best
Hamish

------------------------------
Hamish King
Director Business Development
Hong Kong
hamish.king@cisema.com

Original Message:
Sent: 21-Feb-2021 00:22
From: Anonymous Member
Subject: China - fast track approvals

This message was posted by a user wishing to remain anonymous

Does anyone have an idea whether fast track approval  process exists for an equivalent device  with NMPA? Also is there any way , a change application to a product can be submitted prior to the product renewal coming through ?

thnx