Module 1 2021

25/06/2021

Electronic Submissions: Region by Region

The Organisation for Professionals in Regulatory Affairs

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• The US FDA were the earliest adopters of the concept of electronic submissions, both informally and then more formally • The additional data requirements have made the use of electronic submissions a necessity • The eCTD has been a requirement since 2007 • Thankfully, the slight differences between small molecule and biologics submissions have been removed • But the NDA presubmission process can still lead to some individual requests and inclusions Electronic submissions: Region by region – The United States (1)

The Organisation for Professionals in Regulatory Affairs

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