Science & Technology: Electronic Submissions Gateway in the US and the EU

Posted 01 March 2009 | By Bill Kurani, MSEE, MSRA, BC 

Regulatory agencies in the US, the European Union, Japan and Canada are moving toward requiring drug and biologic submissions in electronic format. The standardized organization of the Common Technical Document (CTD) allows reviewers to quickly review the section of interest and navigate marketing applications and other submissions, facilitating and potentially shortening the time to approval. Clinical data submitted can be readily accessed, allowing reviewers to run additional analyses without having to request these analyses from the company.

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