Thanks for highlighting this! I found an
update here:
On Jan 12, 2022, NMPA issued a notice on its website to collect public opinions on termination of old GCP and medical device advertisement regulations. The collection of public opinions will be ended by Feb 11, 2022.
Since 2019, NMPA has initiated to amend current China GCP (Good Clinical Practice), and in this May, NMPA collected public opinions on the draft of new China GCP.
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Andrea Chamblee Esq., RAC, FRAPS
Senior Counsel, Wilson Sonsini
This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and as a RAPS Fellow.
This is not intended as legal advice. Consult a lawyer for your specific matter.
Maryland
United States
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Original Message:
Sent: 17-Nov-2021 19:06
From: Tracy Yu
Subject: New China GCP will be issued soon
As a member of IMDRF (International Medical Device Regulators Forum), China is actively leading and participating in the formulation of relevant regulatory documents for international medical devices. Since 2019, NMPA has initiated to amend the current China GCP (Good Clinical Practice), and this May, NMPA collected public opinions on the draft of the new China GCP.
The full article can be accessed here, in which it summarizes the major amendments in the new China GCP: https://www.inspirativemedical.com/news/2450/
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Tracy Yu
Senior Project Manager
Seattle WA
United States
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