New FDA Policy Updates, Clarifies Process of Moving to Electronic Submission Forms

Posted 22 May 2013 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has released a new manual of policies and procedures (MAPP) for its internal drug regulatory staff regarding the creation and maintenance of its electronic submissions docket, the system that dictates how pharmaceutical and biotechnology companies submit applications to the agency.

The MAPP, Maintaining CDER's Electronic Submissions Docket, regards the more practical aspects of 21 CFR 11, which permits the Center for Drug Evaluation and Research (CDER) and other FDA units to accept the submission of documents, and notably new drug applications, in electronic-only format.

Those submissions are overseen in part by the Office of Business Informatics (OBI), which is responsible for maintaining a list of submissions that CDER requires to be submitted in electronic format, also known as Docket FDA-1992-S-0039.

The documents contained therein cover the mandatory methods of transmission, file formats, media, protocols for receiving submissions and timelines for the acceptance or rejection of a submitted application.

Switch Process

Other divisions within FDA are meanwhile required to work with OBI to ensure that the agency is working on the same page when it comes to submissions. For example, if an FDA unit is prepared to either start or stop accepting applications in a given format, they must notify OBI of the details of the plan and work with it to develop and maintain guidance on the new submission procedure.

The initiation of that process is a formal one, according to the MAPP. The appropriate office director must send a specific email to OBI citing the appropriate law or regulation supporting electronic submissions, the standard file format to be used, the standard (e.g. eCTD, SPL, etc), media to be accepted, the method of transmission, as well as any other technical protocols.

In turn, OBI is required to act promptly to get that electronic submission system in place as quickly as possible.  

Tags: MAPP, eCTD

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