Electronic Regulatory Submissions and Review

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.]... 

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. 

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... 

Electronic records are defined here as those records used for GxP decision/review processes or regulatory submissions. Appendix 15A helps identify examples. Financial, Data Protection, and other non-GxP records held electronically may also have regulatory requirements, but these are not... 

Essentially, the eCTD is a transport format for facilitating electronic submissions. The eCTD serves as an interface for industry-to-agency transfer of regulatory information while at the same time, taking into consideration the facilitation of the creation, review, life cycle management, and archival of the electronic submission. The eCTD specification lists the criteria that will make an electronic submission technically valid. The eCTD represents a major advance in the submission of information to support an NDA. In the future, companies may be able to send their submissions to several regulatory authorities simultaneously with a single stroke of a computer key. 

Reports may be considered to be reviews. For electronic documents that provide an interpretation of data drawn from electronic records that are already subject to control, there is no clear need to reimpose these controls until the document is used for some official purpose. In a case of submissions, once a submission has been assembled and approved ready for submission to a regulatory agency it would then become an electronic record subject to audit trails. 

The ERSR Web page (http //www.fda.gov/cder/regulatory/ersr) provides information about the electronic submission of regulatory information to the Center and its review by CDER staff. Additional guidance documents, when available in draft or final form, will be added to the Web page. 

The data requirements for approval of a drug are fairly uniform across the world, but there are major differences in the formats in which these data are presented in the dossiers to various regulatory authorities. This has meant ineffective use of effort and manpower. In order to reduce the time and resources needed to compile applications and to facilitate electronic submissions, regulatory reviews and communications and exchange of information between regulatory authorities, the International Conference... 

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