How European regulators view foreign data in the approval process.
The regulation of medicines should be based on sound scientific principles, and where these are uncertain the regulator may have difficulties. Nowhere is this illustrated more clearly than in the debate over how clinical data obtained in one part of the world can be used for regulatory purposes elsewhere.
Breckenridge
A
A
Medicines and Healthcare products Regulatory Agency, London, UK. Alasdair.Breckenridge@mhra.gsi.gov.uk
Hudson
I
I
D017277:Drug Approval / Q000379:methods*; D005062:European Union; D006801:Humans; D038622:Internationality; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*