Questions & Answers Blog on recent webinar on ‘Australia (AU-TGA) now recommends eCTD submission’
Q1. May I know the exact location of CRFs?
Ans. CRFs are located in in both Module 5-3-1-2 (comparative-ba-and-bioequivalence-study-report) or Module 5-3-7 (case-report-forms-and-individual-patients-listings)
Q2. Append operation is limited only to STFs?
Ans. We encourage you to:
Use New, Replace, and Delete.
Only use Append as part of the study tagging files (STF) as defined by the ICH eCTD Backbone File Specification for Study Tagging Files. If you use Append for any other purpose, you will:
Receive a validation warning
Need to include an explanation in the cover letter.
Q3. Bookmarks, hyperlinks and TOCs, more specific guidelines?
Ans. All PDF properties are using as such using for USFDA eCTD.
Q4. What is regional DTD?
Ans. DTD is the rules file for the XML backbone. The DTD defines the elements and attributes that make up a technically valid backbone file. For example, it defines the headings in the CTD structure, there order, and whether they are repeatable. The DTD defines the metadata elements and attributes of each leaf.
Each valid submission will have at least two DTDs, the ICH DTD and the regional Module 1 DTD (region specific information). In addition, if the U.S submission has any studies in Modules 4 or 5, then the eCTD will also contain the STF DTD.
Q5. Difference between eCTD and NeeS?
Ans. eCTD: eCTD electronic submissions have XML support that allows for tracking of the life cycle of the document assessment and medicinal approval process. The eCTD consists of the folder structure, XML backbone and files.
NeeS: non-eCTD electronic submissions (NeeS) do not contain an XML backbone and do not allow for tracking of the life cycle, while a table of contents (TOC) and hyperlinks or codes are used for navigating movement through the documentation. The file with the table of contents for the entire document should be called ctd-toc.pdf. The file with the contents should be called m1-toc.pdf, m2-toc.pdf, m3-toc.pdf, m4-toc.pdf and m5-toc.pdf and need to be included within the appropriate top level folder.
6: What is extra benefit due to XML back bone in eCTD than NeeS?
Ans. The XML backbone defining difference between the eCTD and other submission formats. The XML backbone is used to manage the metadata about the documents and dossier that allow the relationship over the product life cycle to be managed.
Q7: What is meaning of Base line submission?
Ans. It is highly recommended but not mandatory to submit an eCTD baseline when changing from paper or NeeS to eCTD and to provide as much content as possible in the eCTD.
A baseline submission is a compiled submission of the current status of the dossier, i.e. resubmission of currently valid documents that have already been provided to authority but in another format (paper or NeeS).
The sections provided to make up a baseline can be defined by the applicant, but any omissions should not render the submitted content misleading.
Q8. Which are the lifecycle operations again?
Ans. The following four lifecycle operations defined under the ICH eCTD specification:
New
Replace
Delete
Append.
Q9. Are they (AU-TGA) accepting DMF in eCTD Format?
Ans. Yes, AU-TGA accepting DMF in eCTD format.
Q10. What is the maximum file size of an entire eCTD submission that is accepted by the TGA?
Ans. The maximum size of an individual PDF file is 100MB. There is no maximum for the entire submission. The TGA will encourage submission via DVD during the Pilot and until we have a fully developed portal facility with capacity for upload.
Q11. How do I get an eSubmission Identifier from the TGA?
Ans. To get an eSubmission Identifier,
send an email to esubmissions@tga.gov.au
include the following information in your email:
the applicants name as listed in the eBS client database
Name of medicine (the AAN or proposed AANs) or subject of Master File
a description of the Application (application type, dosage form), if referring to a medicine
Name and address of manufacturing site, if referring to a Master File.
Q12: when to ask for esubmission identifier? Before PPF submission or later?
Ans. When an applicant lodges a Pre-submission planning form (PPF), the first phase of the prescription medicines registration process begins. Information about the process is provided in Prescription medicine registration process available on the TGA website.
The PPF provides the TGA with the necessary information on the scope and scale of application to arrange appropriate resourcing for the processing and evaluation of an application, including where relevant, the contracting of external evaluators.
A complete PPF identifies the proposed application type, and contains general information and details of the quality, nonclinical, and clinical evidence to be included in the dossier. The information provided in the PPF allows the TGA to commit to timeframes for the evaluation of the application.
Q13. Could u explain about study tagging file and Node extention?
Ans. Study Tagging Files, or STFs, organize study information into meaningful, standardized headings, not provided by the eCTD DTD, which allows reviewers to quickly understand what has been submitted and what has not. STFs provide consistency over the lifecycle of the regulatory application.
An STF should be provided with the submission of any file, or group of files belonging to a study in Modules 4 and 5. STFs are required by the United States, are not required in Europe and Canada, and are not allowed in Japan.
Node Extension: Node extensions are a way of providing extended organisational information in the eCTD. The node extension should be visualised as an extra heading in the CTD structure and should be displayed as such when the XML backbone is viewed.(Use of node extensions is, however, generally discouraged and should only be done when there is no other feasible means to submit information in the correct regulatory structure).
Q14. What is meaning of ISI Tools?
Ans. ISIToolBox (ISI ToolBox is now TRS ToolBox) is a suite of tools that allow you to create hypertext links and bookmarks and/or copy text, tables, and graphics from PDF files.
15. Which applications require a PPF?
Ans. The prescription medicine registration process described here applies to applications to register a new prescription medicine or to make changes to an already registered medicine that involve clinical, nonclinical or bioequivalence data.
Applicants must ensure they are always using the current version of the PPF. TGA preference is for the Word version of the PPF to be used.
You can download PPF form from
https://www.tga.gov.au/sites/default/files/pm-argpm-process-ppf-140924.docx
Q16 TGA recommend the use of the append operation in life cycle management?
Ans. Not recommended.
Q17 Will TGA accept modified USFDA submissions that include Study Tagging Files (STFs)?
Ans. The submission in eCTD format must adhere to the Australian Module 1 and ICH specifications. Submissions which include STFs will be accepted but are not required. However, if STFs are included, they must pass validation.
Q18 What is a TGA planning letter and when will I receive it?
Ans. A TGA Planning Letter is sent to applicants within six weeks of the TGA processing a complete, effective PPF. This letter provides the date by which the application, including full dossier, must be lodged and the target dates for key milestones (the evaluation plan).
Q19. How competent is KnowledgeNET to other Softwares?
KnowledgeNET is a robust, featured-packed, well established dossier submission and life cycle management solution.
It has great adaptability of compiling dossiers with various global regulatory standards in distinct publishing formats like CTD, eCTD, NeeS, ACTD, GTD, vNeeS and the regional formats.
It is ready with pre-loaded checklists and template structures for US, EU, Gulf (GCC), Australia, South Africa, Asia, CIS and Latam regions that can make dossier compilation process >60% faster.
Benefits for KnowledgeNET-Global Publishing Solutions and Services
Dossier project tracking and life cycle management
Dynamic template structure management
Published document formatting
Re-usability of documents (upload once and use inmultiple dossiers)
Project status dashboard and MIS
Post-submission query tracking, eliminate delays due to queries
Assign query to responsible person with timelines
Real-time alerts and notifications to corresponding users
Set default working project
Auto correct of PDF property as per guidelines
Real-time alerts and notifications to corresponding users
Document transformation, i.e., word to pdf
Project level attributes such as submission, MA grant and approval date
For more details you can go to below link:
