Preparing for FDA Mandated ectd Submissions Outsourcing in Clinical Trials West Coast 2016 11 Feb 2016
2 Agenda Introduction FDA Regulatory Background FDA Timetable International ectd What is an ectd Options for ectd Management Preparing for ectd Submission Transitioning from Paper to Electronic FDA ectd guidance
FDA s Electronic Submission Requirements On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 was signed into law 3 Section 745A(a) of the FD&C Act, added by section 1136 of FDASIA requires that submissions be submitted in electronic format Published Final Guidance on December 17, 2014
FDA Timeline NDA, ANDA, BLA and DMF 4 Final ectd guidance released on May 15, 2015 Requirement begins May 15, 2017 All Applications, Amendments, Supplements must be in ectd
FDA Timeline IND 5 Final ectd guidance released on May 15, 2015 Requirement begins May 15, 2018 All Applications and Amendments must be in ectd
Submission Statistics 6 32,693 (17%) 2015 Submissions 40,853 (22%) 115,912 (61%) Paper ectd esub 39% of all submissions did not meet the ectd requirements
7 ectd - ROW Submissions ectd is the preferred format for many Regulatory Authorities and is widely used in: Australia Canada China Croatia Japan Saudi Arabia Singapore South Africa Switzerland EU/EEA Member States 2015 SynteractHCR. All rights reserved. SHARED WORK. SHARED VISION.
ectd - EMA Submissions 8 January 2009: ectd format now required for Centralized Procedure (CP) January 2015: Guidance for Implementation of mandatory ectd format Q3 2015: Decentralized procedure (DCP) Q1 2017: Mutual Recognition Procedure (MRP) Q1 2018: ectd for all Regulatory Activities in the EU (DCP/MRP)
9 What Is An ectd? It is an electronic version of the Common Technical Document (CTD) The CTD is an ICH Harmonized format for submission to Competent / Regulatory Authorities The CTD is organized into five modules
CTD Triangle 10
ectd Published Output - File Share View 11
ectd Published Output - ectd Viewer 12
Sequence and Lifecycle 13 Shows the submission history and Lifecycle operations Previous versions are always available
Options for ectd Management 14 Implement your own ectd publishing software and set up an ESG account Outsource to single ectd vendor to maintain full IND/NDA Outsource to multiple vendors submitting at clinical trial level Per FDA data: less than 1% of all electronic submissions were rejected in FY 2015 Largest problem type (40%) was the receipt of duplicate sequences
Preparing for ectd Submission 15 If you have not previously submitted in ectd format, or do not have an electronic submissions gateway (ESG) account you will need to: Step 1: Notify FDA esub group of intent to submit ectd Step 2: Set up and test Electronic Submissions Gateway (ESG) account Step 3: Submit a Sample ectd
Step 1 Notify esub Group 16 email the Electronic Submission Support Team at ESUB@fda.hhs.gov to inform them of your plans When sending an email please include the following: a. Contact person name - this will be the main contact during the sample submission phase b. Contact person's company name c. Contact person's mailing address d. Contact person's phone number e. Contact person's email address f. Date when you plan to submit an actual application g. Description of sample to be evaluated Note: The information you provide in your email request for a sample number should also be provided in the cover letter of your sample
Step 2 Setup ESG Account 17 Send an email to ESGHelpDesk@fda.hhs.gov requesting a WebTrader test account Make the subject of the email New WebTrader Test Account Registration When sending an email please include the following: Company name First and last name Phone number Submission method: WebTrader
Step 2 Setup ESG Account Preparatory Activities 18 Submit Letter of Non-Repudiation Agreement Obtain Digital Certificate Configure Java on local computer
Step 2 Setup ESG Account Apply for Production Account 19 Send connection test Send guidance compliant test submission based on Center Optional Send 7.5 GB Load Test Once successful, your account will be migrated to production, and you will receive an email with production account confirmation and production URL
Step 3 Submit a Sample ectd 20 Submit ectd sample to review division refer to recommended contents of the sample submission http://www.fda.gov/downloads/drugs/ DevelopmentApprovalProcess/ FormsSubmissionRequirements/ ElectronicSubmissions/UCM163177.pdf This is different than the ESG Compliant Test Submission
Step 3 Submit a Sample ectd Contents Of Sample 21
Transitioning From Paper to Electronic 22 Notify FDA Project Manager of intention to switch to ectd Send in sequence with intent to transition using current submission methods. Send in Anchor ectd Submission Transitioning to ectd format and resubmission of Documents When transitioning to ectd format, You are not required to resubmit documents already submitted in paper or other electronic format Be mindful of cross references and resubmit documents as appropriate to facilitate review
Summary 23 Plan and prepare early for electronic submission Build and maintain a knowledge base: Understand the process Current recommendations and common issues FDA resources (websites, guidance documents, etc.) Understand FDA to CTD placement Understand ectd Granularity and Specifications. Set up digital signature and use FDA fillable forms with digital signatures (required) Electronic Submissions Gateway (required >10gb) Validate your ectd submission prior to submitting
FDA ectd Guidance 24 ectd Basics http://www.fda.gov/drugs/ DevelopmentApprovalProcess/ FormsSubmissionRequirements/ElectronicSubmissions/ ucm153574.htm ectd Standards http://www.fda.gov/downloads/drugs/ DevelopmentApprovalProcess/ FormsSubmissionRequirements/ElectronicSubmissions/ UCM453922.pdf ESG Account http://www.fda.gov/forindustry/ ElectronicSubmissionsGateway/default.htm
Thank you for your attention
Questions? Thomas Christensen Senior Regulatory Affairs Manager Direct: 919-674-8099 Mobile: 919-368-7617 Thomas.Christensen@synteracthcr.com