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eCTD Specification11 December 2014 2014 Factorytalk Co., Ltd. Proprietary and Confidential
orytalkPartnersProjects 50 150,000 anPartnershipforMESeQMSgrowthinRegionalProjects ilandcomplianceservicesGermanycompanyinSingaporeUS d wideOfficesrange of solutionprojectsMan-hours 2014 Factorytalk Co., Ltd. Proprietary and ConfidentialCountries(2)
Supporting nningAssessment GAP Analysis /Audits GMP HealthCheck URS Facility Design Validation RiskAssessments Training &Workshops CSV and ITstrategy Project ManagementValidation servicesQMS remediationSupplier AuditsTechnologySolutions: ERP MES eQMS LIMS/LES Pre inspectionreadiness Mock inspections SubmissionsManagement Audit / Inspectionsupport Post audit support Overseas marketdevelopment andsourcing Productivity /processimprovement Supplier sourcing eSubmissionsGMP standards 2014 Factorytalk Co., Ltd. Proprietary and Confidential(3)
2000yrs 1000yrs 200yrs 150yrs 50yrs 5yrs 10yrs 20yrs 30yrs 2014 Factorytalk Co., Ltd. Proprietary and Confidential(4)
Impact on access to information 80% of employees waste an average of half an hour perday retrieving information at Factorytalk this equates to 1.3M THB/yr 60% spend an hour or more duplicating work at Factorytalk this equates to 2M THB/yrTotal 3.3M THB*Source: BAE Systems 2014 Factorytalk Co., Ltd. Proprietary and Confidential(5)
ACTD ASEAN established the ASEAN Common TechnicalDocument (ACTD) to create harmonizedrequirements and a common format for allsubmissions of dossiers in the ASEAN countries. The ACTD is based on the European standard (CTD),CTD format is required for the registration of all drugproducts into EMEA regulated countries. Contents of Module 2 in CTD were separate in toACTD Part 2,3,4 as paper management during reviewprocess is easier. TOCs aren’t required anymore in eCTD 2014 Factorytalk Co., Ltd. Proprietary and Confidential(6)
A eCTDICH M4RegionalAdminInformationNOT Part ofthe CTDACTDModulePart 1 1Module 2NonclinicalOverviewQualityOverallSummaryACTDPart 2NonclinicalSummaryACTDPart 3ClinicalOverviewThe calStudy ReportsStudy ReportsModule 3Module 4Module 5 2014 Factorytalk Co., Ltd. Proprietary and Confidential(7)
Business ProtocolPrepare SubmissionApplicationeSubmission IdentifierPrepare the cover letterand validation reportDelivery of the eCTDApplication at FDA (CD)FDA : Feedback onValidation of ApplicationFDA : Startreview process 2014 Factorytalk Co., Ltd. Proprietary and Confidential(8)
Regional Content Module 1 administrative and prescribinginformation- The content and numbering of Module 1 for Thailand ismodelled after the EU Module 1 content as described in the2008 version of the EU Notice to Applicants. Additionaldocuments specifically required by Thailand not covered by theEU structure is describe in 1.A Additional Data of TH Module 1and Regional SpecificationModules 2 to 5-No change from ICH eCTD ierValidationreportDelivery theapplicationApplicationfeedback 2014 Factorytalk Co., Ltd. Proprietary and ConfidentialReviewingprocess(9)
Handling of Empty or Missing eCTD Sections For new applications, including generic applications, detailedstatements justifying the absence of data or specific CTDsections should be provided in the relevant Quality OverallSummary and/or Nonclinical/Clinical Overviews e.g. Module 2.3,2.4, or 2.5. For a generic application, there is no need to provide ajustification for content that is typically absent. Note that placeholder documents highlighting no relevantcontent should not be placed in the eCTD alidationreportDelivery theapplicationApplicationfeedback 2014 Factorytalk Co., Ltd. Proprietary and ConfidentialReviewingprocess( 10 )
Bookmarks, TOCs, and Hyperlinks Bookmarks and/or TOCs make the review more efficient.The FDA recommends that documents with more than five pages andwith multiple sections should provide a Table of Contents, and/or ifappropriate, a Table of Tables, Table of Figures, etc. on the first pageof the document.Hyperlinks are recommended when they would aid the evaluation inways not already possible through the use of the eCTD index.xml anddocument navigation aids.Applicants should consider when creating cross document hyperlinksthat they can cause confusion later in lifecycle and therefore bedistracting for an efficient dationreportDelivery theapplicationApplicationfeedback 2014 Factorytalk Co., Ltd. Proprietary and ConfidentialReviewingprocess( 11 )
File Reuse The FDA accepts and encourages applicants to make active use of file reuse. Applicants should not submit the same document multiple times. File reuse should be used when -a file is submitted multiple times within one sequence,-a file already submitted in an earlier sequence is being referenced again,-or if a file submitted in another application is being referenced in a new application.Please note that the FDA is implementing a flat repository structure to makecross application referencing possible.-Links to content provided in other applications simply need to be directed out of the currentapplication structure and into the structure of the corresponding application.-All application will be stored using the eSubmission Identifier to make cross referencingeasily predictable and lidationreportDelivery theapplicationApplicationfeedback 2014 Factorytalk Co., Ltd. Proprietary and ConfidentialReviewingprocess( 12 )
Structure Naming conventions for thecontent files are irrelevant forelectronic review All content must bereferencedby the appropriate XML filesfor efficient navigation. Applicants should concentrateon providing precise butinformative leaf titles toaid alidationreportDelivery theapplicationApplicationfeedback 2014 Factorytalk Co., Ltd. Proprietary and ConfidentialReviewingprocess( 13 )
eSubmission Identifier A request for an eSubmission identifier should madevia email. The request will require the followinginformation:-Licensee NumberDescription of Application.Dosage FormINN or Generic NameStrengthWHO ATC CodeSequence TypeApplication formCPP alidationreportDelivery theapplicationApplicationfeedback 2014 Factorytalk Co., Ltd. Proprietary and ConfidentialReviewingprocess( 14 )
eSubmission Identifier The eSubmission Identifier will be issuedwithin 10 days of application. The Applicantmust check on the THAI FDA online servicefor a response informing them of theireSubmission Identifier. After receiving theidentifier, the Applicant must then make anappointment for submission within 30 tionreportDelivery theapplicationApplicationfeedback 2014 Factorytalk Co., Ltd. Proprietary and ConfidentialReviewingprocess( 15 )
Validation Criteria No major new or unusual validation criteriadeveloped from EU eCTD V3.2 Other regions were analysed, compared and adoptedif suitable Detail validation criteria can be found at TH RegionalSpecification and Validation idationreportDelivery theapplicationApplicationfeedback 2014 Factorytalk Co., Ltd. Proprietary and ConfidentialReviewingprocess( 16 )
Items worth notingValidation Criteria Files and Folders- There are no naming conventions being validated ICH Backbone- File Reuse - Information is collected about references outside theapplication and sequence as well as multiple references to a file within asequence TH Regional- File Reuse- Cover Letter must be New- Information is collected when Application Form is not onreportDelivery theapplicationApplicationfeedback 2014 Factorytalk Co., Ltd. Proprietary and ConfidentialReviewingprocess( 17 )
Validation ToolsMost vendors offer free basic versions of theirvalidation tools No excuses for submitting applications that do not pass technical validationMake sure you validate on the media being submittedValidation should be limited to criteria specified by the FDA- Some vendors provide extended profiles, these should not be provided with theapplicationList of validation tools will be provided on the eSubmission Website asvendors provide evidence that they can sufficiently validate the FDArequirementsCurrent free version of validation tool being used by the FDA can be found at:- http://www.lorenz.cc/esolutions/eValidator/ (Link also provided on FDAeSubmission idationreportDelivery theapplicationApplicationfeedback 2014 Factorytalk Co., Ltd. Proprietary and ConfidentialReviewingprocess( 18 )
Business Protocol for SubmittingeCTDExpected Structure of Submitted Media and MediaFormats Expected structure of submitted media- Content should be submitted in an application folder named after the eSubmission identifier.- The sequence folder and its contents should be placed in this application folder.- Large applications must be split and submitted on multiple items e.g. DVDs- The overall folder structure should be included on each media so that content can be easilymergedMedia formats- The media formats acceptable when submitting an eCTD are:o CD-R, DVD-RAM, DVD R/-R,- Ensure that you do not use:o double-sided discs, rewritable discs or compressed or zipped files (except for entifierValidationreportDelivery theapplicationApplicationfeedback 2014 Factorytalk Co., Ltd. Proprietary and ConfidentialReviewingprocess( 19 )
Delivery of the eCTD Application The Applicant will need to make an appointmentthrough drug esubmissions@fda.moph.go.th anddeliver the application personally at the Division ofPolicy System Development. The eCTD will bevalidated and imported into the THAI FDA ReviewSystem together with the applicant. Once acceptedand submitted, the applicant will be given back theirmedia to tionreportDelivery theapplicationApplicationfeedback 2014 Factorytalk Co., Ltd. Proprietary and ConfidentialReviewingprocess( 20 )
Application feedback THAI FDA will inform applicants if there areproblems experienced during the upload ofan eCTD sequence. Confirmation of validation document will beissue during rValidationreportDelivery theapplicationApplicationfeedback 2014 Factorytalk Co., Ltd. Proprietary and ConfidentialReviewingprocess( 21 )
Start Review ProcessInitial istrationProcess(include LoQ)Delivery theapplicationApplicationfeedback 2014 Factorytalk Co., Ltd. Proprietary and rocess( 22 )
Technical Feedback 1 from 9 companies facing media failure 2 from 9 companies not passed validationprocess of THAIFDA 2 from 9 companies have incompleteAdministrative information 2014 Factorytalk Co., Ltd. Proprietary and Confidential( 23 )
Feedback from Pilot Group 2014 Factorytalk Co., Ltd. Proprietary and Confidential( 24 )
Thank you!Teerapong Cheepcholtch@factory-talk.comT: 662-630-4525 2014 Factorytalk Co., Ltd. Proprietary and Confidential( 25 )
with multiple sections should provide a Table of Contents, and/or if appropriate, a Table of Tables, Table of Figures, etc. on the first page of the document. Hyperlinks are recommended when they would aid the evaluation in ways not already possible through the use of the eCTD index.xml and document navigation aids.
