Electronic Regulatory Submissions and

Electronic Regulatory Submissions and Review (CDER) This document (from http //www.fda.gov/cder/regulatory/ersr/default.htm) provides specific ESG guidance for CDER submissions, including NDAs, INDs, and DMFs. 

For more details concerning electronic submissions, see Electronic Regulatory Submission and Review (ERSR) guidelines.]... 

All LIMS functions (e.g., manual data entry, automated data entry, and report generation) should be assessed to evaluate the effect that they could have on the data that will support regulatory submissions and release of product to market. This approach must be methodical to ensure that relevant functionality is not overlooked. It is essential, for instance, that Business Continuity Plans are verified as being appropriate and workable. This testing should cover all aspects of the recovery process from the loss of individual components (e.g., an analytical instrument interface) to the full loss of LIMS (e.g., representing a catastrophic failure of the LIMS server). The criticality of the data associated with the management of Electronic Records and Electronic Signatures should also be a focal point. However, it must be accepted that these assessments can be subjective and therefore they rely heavily on the experience of the assessors. 

Electronic regulatory submissions combine components from specific systems, e.g., computer-aided review tools and electronic document management systems. Electronic publishing systems assemble electronic documents and images into electronic dossiers. The validation requirements of the publishing system, over and above the requirements for each component system should be assessed. 

The requirements for regulatory approval and intellectual property management, and in particular the ability to file USPTO patent submissions, do place constraints on what systems can be applied for record keeping, but the good news is that there are no insurmountable barriers to these records being captured and managed electronically. 

Food and Drug Administration. Guidance for Industry, Providing Regulatory Submissions In Electronic Format—General, FDA, Rockville, MD, 1999. 

The common technical document (CTD) (ICH M4) is now a requirement. The CTD is the agreed common format for the preparation of a well-structured application to the regulatory authorities and has had an impact on all organisations as database integration and electronic submissions become more common. 

U.S. Department of Health and Human Services (2006), Guidance for industry Providing regulatory submissions in electronic format—Human pharmaceutical product applications and related submissions using the eCTD specifications, Food and Drug Administration, Rockville, MD. 

Center for Drug Evaluation and Research (CDER), Center for Biologies Evaluation and Research (CBER). Guidance for Industry. Regulatory Submissions in Electronic Format General Considerations, Jan. 28,1999. 

NDAs. Please refer to Providing Regulatory Submissions in Electronic Format-Human Pharmaceutical Product Applications and Related Submissions. 

Drug Master File (DMF). Refer to the Guidance for Industry Providing Regulatory Submissions in Electronic Format-Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications for information on the submission of electronic DMFs. 

Draft Guidance Providing Regulatory Submissions in Electronic Format-Prescription Drug Advertising and Promotional Labeling. Optional format PDF. (Issued January 2001, Posted January 30,2001)... 

DFS is being developed incrementally. The first phase focuses on building an electronic repository for final review documents and for capturing signature information. The review documents tracked and saved by DFS are associated with regulatory submissions in the Centerwide Oracle Management Information System (COMIS). Future phases of DFS will include an update of COMIS... 

Draft Guidance for Industry Providing Regulatory Submissions in Electronic Format for Orphan Drug and Humanitarian Use Device Designation... 

Format and tables conform to Guidance for Industry Providing Regulatory Submissions to CBER in Electronic Format—Investigational New Drug Applications (INDs)... 

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