Sat, 18 Nov 2017

Good eCTD Practices: ways to Avoid Protracting Review Process

 

Eshan Gera1*, Kamlesh Sharma1, Shilpi Khattri1, Pramod Kumar T.M1.

1.JSS College of Pharmacy, JSS University, S.S.Nagara, Mysore-570015, Karnataka, India.


 

ABSTRACT

In view of digital global agenda, the time has come for Good eCTD Practices. This article holds discussion about the measures to be taken before preparing and while submitting the dossier in eCTD format. The eCTD is an interface between industry and agency for transferring regulatory information while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission. eCTD is an electronic arrangement with extension of CTD, whose structure is specified by XML (Extensible Markup Language) eCTD DTD (Document Type Definition). While many organizations have delayed their adoption of eCTD format, the USFDA and several other global agencies are pressing forward towards its mandate. Though eCTD specification lists the criteria that will make an electronic submission technically valid, many companies are suffering from delays that occur not due to lack of data but due to technical and other issues of eCTD submission. The eCTD submission requirements definitely pose great challenges to the industry and regulatory agencies. There has to be an investment in information and communication technology as well as development of digital competitiveness among the regulatory professionals within the industry and regulators, alike. The regulatory professionals should know the standards, groundwork, expertise and technology required to submit an electronic submission globally. Due to its cost effectiveness, and because it guarantees a response from the recipient regulatory agency, reducing time to market, the eCTD has become the standard for numerous regulatory agencies around the world.

Keywords: eCTD, Electronic Submission, Study Tagging Files, Granularity, eCTD validation


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