RAPS 2012 Attendees Focused on Electronic Submission Mandate

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I recently attended the RAPS 2012 annual meeting in Seattle, and had the opportunity to speak with many different regulatory professionals from all over the country. One of the main themes that seemed to be on everyone’s mind was the impending PDUFA V mandate on electronic submissions. Based on the information gathered from the sessions and around the exhibit area, it is clear that there is some trepidation as to how to manage the mandate for small and mid-sized companies, many of which are searching for resources and guidance as they tackle creating and implementing the policies and procedures needed to comply.

Here is a brief summary of how the mandate will be implemented by the agency over the next few years:

Twenty-four (24) months after publication of the final guidance:
All new original NDA and BLA submissions, all new NDA and BLA efficacy supplements and amendments, all new NDA and BLA labeling supplements and amendments, all new manufacturing supplements and amendments, and all other new NDA submissions, must be submitted electronically.

Thirty-six (36) months after publication of the final guidance:
All original commercial INDs and amendments, except for submissions described in Section 561 of the Federal Food, Drug, and Cosmetic Act, must be submitted electronically.

Those companies that currently submit paper CTDs seem to realize the need to quickly start the process to identify vendors, acquire templates, train staff, and create SOPs for the change over and how imperative it is to begin the process as early as possible. Having that plan in place should minimize some sleepless nights, and make the transition much easier.

Author: Rob Barlow

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