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07.09.2011
PDUFA V draft performance goals and procedures foresee mandatory eCTD submissions for human medicinal products in U.S.
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The U.S. Food and Drug Administration (FDA) has published the draft PDUFA V (Prescription Drug User Fee Act) "Reauthorization Performances Goals and Procedures Fiscal Years 2013 Through 2017. Background: The PDUFA law allows the FDA since 1992 to raise fees from human drug manufacturers and /or marketing authorization holders to found the drug approval / review process. In order to continue collecting such substantial fees, the FDA is required to meet certain performance benchmarks, primarily related to the speed of certain activities within the NDA review process. PDUFA V must be reauthorized in 2012 and concerns the fiscal years 2013 - 2017. Among many other proposed improvements related to the FDA review procedures, the current draft foresees to mandate the eCTD as the submission format for NDA and BLA submissions, starting 24-months after publication of the corresponding final guidance. For commercial INDs and amendments a period of 36-months after publication of the final guidance will apply.
Such final guidance will be released no later than 12 months from the close of a public consultation period on the draft guidance. The corresponding draft guidance will be issued by December 31, 2012 the latest.
The initial FDA guidance shall specify the format of electronic submission of applications using eCTD version 3.2.2 unless, "after notice and an opportunity for stakeholder comment, FDA determines that another version will provide for more efficient and effective applicant submission or FDA review." In such cases where the final guidance will be revised due t a new version of electronic standards or formats, the FDA "shall also accept submissions using the previous version for no less than twenty-four (24) months."
[Source: FDA website]
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