Analysis of New, Draft TGA (Australia) M1 CTD Guidance

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I sat down to take a look at the new TGA (Australia) Draft Module 1 Administrative Information and Prescribing Information. This is a whopper of a document (96 pages), carefully written to provide a wealth of additional information to sponsors.

The document contains a number of major and minor changes, and has been re-formatted to make extensive use of bullet lists for greater clarity. The new guidance addresses subsequent data submissions in much more detail than the previous guidance. It also provides references to additional materials and forms in many places.

The changes are significant enough to require a very thorough study by anyone submitting in Australia. I provide a number of highlights below, but changes are so numerous that I no doubt missed a number of them. After making it through about half the document, I experienced review fatigue – so the rest of the assessment will appear in my next post.

General Information

  • TGA has provided a summary of requirements based on application category (Category 1 and 2, Category 3, Notifications (“Safety Related” Notifications, “Self Assessable” Notifications and Requests for Correction to Register Entry), and other data types (Section 31 Responses, additional data, Certified Product Details)).
  • Any submission-related data to be sent to the TGA after the original submission dossier was lodged (e.g. Section 31 response, additional data) must be provided as addenda to the relevant Module; data must meet CTD requirements and an additional expert comment must be provided.
  • Requirements for formats and copies are changing:
    • When preparing a Category 1 or Category 2 submission dossier for lodgement with the TGA, the CTD format dossier must be provided in both paper and electronic medium.
    • Category 3 submissions are required on paper only but must still be in CTD format.
    • See the document for quantities required for paper submissions
    • Clarifications provided about the organization of Category 3 documents, responses to questions, Annexes to Module 1 and multiple versions of a given document (section “Organising documents”)
  • Submitted of double-sided documents is addressed in more detail
  • A section on Packaging has been added
  • A discussion on the Handling of Subsequent data has been added.

Format of Module 1

  • TGA has provided a summary of requirements based on application category, generally in each section, and discusses the applicability of most sections to specific application categories. In each area, there is also a discussion of under what concisions the applicable documents are required.
  • Electronic lodgement cover sheet: the use of this document is discussed. (“A signed electronic lodgement cover sheet must be included in Module 1.0.0 when the submission has been lodged electronically via eBS prior to the submission dossier being sent to the TGA.) This is now section 1.0.0, which bumps all of the M1 1.x section numbering up.
  • Letter of Application: Detailed requirements for the Letter of Application are spelled out. TGA notes: “The letter of application is used by TGA staff, in conjunction with the application form, to confirm the legality of the application. A submission that differs significantly from its pre-submission planning form may be deemed to be ineffective.”
  • Table of Contents: Additional details are given for the TOC (e.g., referencing studies). Each individual CTD module is required to have its own Table of Contents.
  • Application form: special instructions are given for Category 1 and Category 2 submissions that have been lodged electronically via eBS. More detailed instructions for completing the paper form are provided.
  • A new section, 1.2.2 Pre-Submission details, is to be provided when a pre-submission form has been lodged for your Category 1 or Category 2 submission.
  • A new section, 1.2.3 Patent certification, is to be provided before a newly approved registration can be included in the ARTG.
  • In section 1.3.1 Proposed Australian product information and package inserts, significant additional details are given.
  • 1.3.3 Therapeutic goods and use of human embryos or human embryonic stem cells or material derived there from now requires a Declaration Form for most applications
  • Legal basis for labeling is laid out in section 1.3.4 Label mock-ups and specimens.
  • In section 1.4 information about the experts, significant additional information is included for each category (Quality, Nonclinical, Clinical). Declarations for Australian experts, experts from EU, and other overseas experts are discussed and the experts’ CVs required.
  • Section 1.5.1 Literature based submissions – sub-sections have been defined. Additional references are provided that give more details.
  • Section 1.5.2 Orphan drug designation – you now must include the TGA letter granting approval in this section.
  • Section 1.5.3 Genetically modified organisms: Consent from the Office of the Gene Technology Regulator now requires copies of any licence, acknowledgement of receipt of application for a licence and/or other written consent from OGTR (or alternative declarations). Further references are cited.
  • In Section 1.5.5, Co-marketed medicine declarations – more detail is provided on the letter required from the third-party sponsor.

Author: GS

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