Friday, February 07, 2025 9:29:16 AM
You are exactly right ..... somewhat.
Here is the agreement.
https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreements-mra
However there is a provision for a case by case basis where medicines can be imported into the USA if a doctor so orders. But no more thana 90 day supply at a time. Plus the company can not market the drugs in America.
It also significantly cuts down the approval time.
This quote sums it up pretty good. If MHRA approval is granted it will go a long way toward FDA approval also. Cutting down time........
Therefore, the MHRA is pleased to co-operate with the FDA to facilitate the sharing of otherwise non-public documents and information for these purposes and by this document set out a framework understanding of the information which they may share with each other and the basis upon which they may share it. This co-operation and framework understanding shall not create any kind of binding legal obligation on the part of the MHRA or the FDA.
Here is the agreement.
https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreements-mra
However there is a provision for a case by case basis where medicines can be imported into the USA if a doctor so orders. But no more thana 90 day supply at a time. Plus the company can not market the drugs in America.
It also significantly cuts down the approval time.
This quote sums it up pretty good. If MHRA approval is granted it will go a long way toward FDA approval also. Cutting down time........
Therefore, the MHRA is pleased to co-operate with the FDA to facilitate the sharing of otherwise non-public documents and information for these purposes and by this document set out a framework understanding of the information which they may share with each other and the basis upon which they may share it. This co-operation and framework understanding shall not create any kind of binding legal obligation on the part of the MHRA or the FDA.
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