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Which countries have officially adopted ICH-GCP E6(R2) as a standard, in addition to U.S., EU, Japan, Canada, and Australia?
Suggested Answer: D
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India has aligned national regulations with ICH-GCP.
DCGI/ICMR Guidelines (India): Explicitly adopt ICH E6(R2) as part of its Good Clinical Practice standards.
China and Brazil are harmonizing, but full official adoption is noted in India.
12 comments · newest first
KA
Kanisha
3 days ago
Switzerland seems likely too. They have strict regulations.
GE
Georgiana
8 days ago
I agree, but what about India? They have a lot of trials happening.
JA
Jade
13 days ago
I think China is a strong candidate. They have a growing clinical trial industry.
AD
Adrianna
18 days ago
All of them except Switzerland, I believe.
SA
Samira
24 days ago
I’m not sure about Brazil, seems off.
AL
Alfred
29 days ago
Wait, Switzerland? That’s surprising!
TO
Toshia
1 month ago
Definitely Brazil too!
CA
Catalina
1 month ago
I think China and India are on the list.
CH
Cherry
1 month ago
I recall Switzerland being mentioned in some materials, but I can't remember if they officially adopted E6(R2). This is tricky!
PH
Phung
2 months ago
I could be wrong, but I think India has also been aligning with ICH-GCP standards recently. It’s a bit fuzzy though.
DE
Dexter
2 months ago
I’m not entirely sure, but I feel like Brazil might be on that list too. I remember a practice question mentioning their regulatory updates.
SH
Sherly
2 months ago
I think I remember that China has been making strides in adopting international standards, so maybe it's A?