What are the major differences between US FDA Regulations & EU Directive ?
CHP: From what I see, the differences are mostly procedural. US FDA regulations are binding. The CT Directive has yet to be translated into a single law. To the same end, the US has an Investigational New Drug (IND) application whereas in the EU there is an Investigational Medicinal Product Dossier (IMPD). One difference is that in the EU a sponsor from a non-EU country must have a legal and formal legal representative in the EU which could be a CRO. The EU does not have a document like the FDA form 1572 but CRO’s in the EU generally complete one in case the data is needed in the US. There are a myriad of other small but significant differences. Perhaps Venkat can help with this?
