|
United States |
 |
| In
the US, the ICH GCP guidelines are not mandatory. They have been put
forth by FDA as a guideline, not as regulation. From the FDA perspective,
the ICH GCP guidelines detail comprehensive GCP standards that are
acceptable to the FDA, and they provide guidance for the conduct of
international studies. |
|
Japan |
 |
| The
Japanese have not fully implemented the ICH GCP guidelines in their
original format. Instead, they undertook the challenge of rewriting
their GCPs in 1998. Because the Japanese practices are quite different
from those in the EU and the US, the Japanese are having to implement
significant cultural changes in order to more closely align their
practices with those outlined by the ICH GCP guidelines. |
|
European Union |
 |
| The
Draft Clinical Trials Directive of 1997 incorporates some parts of
the ICH GCP guidelines, making these sections regulation in the EU.
However, full implementation has been delayed due to diversity of
cultural and political views amongst the EU nations. |
|
Canada |
 |
|
Canada has fully implemented the ICH GCP guidelines as regulation. |
|
