China may now approve drugs based on foreign clini
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Posted On: 10/10/2017 2:01:08 PM
China may now approve drugs based on foreign clinical trials. This article was behind a paywall so this is the blurb I got in an email:
In my opinion Chinese consumers will be MUCH safer relying on foreign clinical trials than Chinese ones, which have been plagued with falsified-data scandals.
What this means for us is that Brilacidin and whatever other drugs of IPIX get approved = can apply for approval in the huge market that is China, without the expense of clinical trials there.
Quote:
China hastens drug approval with embrace of foreign data: "... companies [in some cases] now be allowed to avoid Chinese trials altogether by using data gathered overseas, the ruling Communist party’s Central Committee said on Sunday [... and the] Chinese Food and Drug Administration said the use of overseas clinical data would be dependent on demonstrating the results were applicable to “eastern” people. Analysts said specifics of how to meet that requirement have yet to be released, but that it would probably mean including a certain number of people of Asian or Chinese origins in a trial."
In my opinion Chinese consumers will be MUCH safer relying on foreign clinical trials than Chinese ones, which have been plagued with falsified-data scandals.
What this means for us is that Brilacidin and whatever other drugs of IPIX get approved = can apply for approval in the huge market that is China, without the expense of clinical trials there.
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