Best Practices for Submitting Promotional 2253 Submissions in the New Module 1 Specification

Abstract

June 2016 marks 1 full year since the optional implementation of US Module 1 Specification v2.3. Since its release, pharma companies have dealt with expanded submission-level metadata fields, the ability to submit advertising and promotional submissions, and more rigid validation criteria. Prior to transitioning, sponsors must ensure their building and validating tools are up-to-date, that a system is in place to integrate departments working together for the first time, and that all guidance documents are understood and implemented. Sponsors now can group submissions across application types, which will help save rework across submissions. Looking at one submission type now accepted in eCTD, this paper will explore the new functionality that has created new possibilities and challenges for Regulatory Operations.

Keywords

advertising/promotional Module 1 FDA eCTD

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References

eCTD backbone files specification for module 1. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163552.pdf. Accessed July 1, 2016.

Comprehensive table of contents headings and hierarchies, http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163175.pdf. Accessed June 29, 2016.

Draft guidance: Providing regulatory submissions in electronic and non-electronic format—promotional labeling and advertising materials for human prescription drugs. Guidance for industry. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM443702.pdf. Accessed June 20, 2016.

File formats. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM347471.pdf. Accessed June 25, 2016.

E-signing. http://www.fda.gov/forindustry/electronicsubmissionsgateway/ucm113223.htm. Accessed July 28, 2016.

Specifications for eCTD validation criteria. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM366165.pdf. Accessed July 27, 2016.