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TT 12/2025 (CTD/ACTD) Dossier Assistant — PharmApp

05/11/2025
Admin

 

TT 12/2025 (CTD/ACTD) Dossier Assistant


Overview

TT 12/2025 (CTD/ACTD) Dossier Assistant is a PharmApp module that helps RA/QA teams build a registration dossier checklist aligned with Vietnam MOH Circular 12/2025 in CTD/ACTD format.

It standardizes the dossier structure and adapts automatically to your selections (product type, dosage form, route of administration, sterility, imported goods, CEP/DMF for API, and fixed-dose combinations). The module also supports keyword filtering, quick reference links, JSON/ASCII export, and a live activity log.

Version note: _tt_12_v0 has been removed. Please use tt_12_v2 (recommended) or tt_12_v1.

Access

  1. Sign in at www.pharmapp.vn.
  2. Open Workspace → All Modules → TT 12/2025 Dossier Assistant (CTD/ACTD).
  3. Under Choose version, select tt_12_v2 (recommended).
  4. Pick your language (Vietnamese or English).

Quick Start

  1. Set metadata at the top of the page:
    • Product type (Generic, Innovator, Herbal, …)
    • Dosage form (Tablet/Capsule, Injection, Topical, …)
    • Route (Oral, Parenteral, Topical, …)
    • Toggles: Imported?, Sterile?, Co-packed solvent?, CEP/DMF for API?, Combination (≥2 APIs)?
    • Data folder (where you keep templates/checklists)
    • Keyword filter (to locate items quickly)
  2. Click Create/Refresh Checklist. The app generates the appropriate CTD/ACTD sections based on your selections.
  3. Expand each Module and mark status/notes:
    • Module 1 — Administrative (M1)
    • Module 2 — CTD Summaries
    • Module 3 — 3.2.S Drug Substance (API)
    • Module 3 — 3.2.P Drug Product
    • Module 3 — 3.2.A Appendices
    • Module 4 — Nonclinical
    • Module 5 — Clinical
  4. Save or share your progress:
    • Export JSON to preserve your work.
    • Import JSON later to continue using exactly where you left off.
    • Export ASCII for lightweight review and easy diffing.

Key Features

  • Auto-configured checklist based on product attributes (sterility, imported, CEP/DMF, combinations).
  • Keyword filter for fast navigation across items.
  • Quick reference links to standards and guidance.
  • JSON import/export to resume work between sessions or share with teammates.
  • ASCII export for text-based review or attachment in SOP/Email.
  • Real-time activity log for traceability.

Recommended Workflow

  1. Choose tt_12_v2 → select English.
  2. Set product metadata and toggles.
  3. Click Create/Refresh Checklist.
  4. Review M1–M5, tick/annotate items (present/missing/not applicable), add short notes.
  5. Export JSON at the end of the session.
  6. Next time, sign in at www.pharmapp.vn, open the module, Import JSON to continue using the same checklist; update items and re-export as needed.

Tips

  • Selecting Sterile or Parenteral automatically surfaces sterility-related requirements (e.g., media-fill, sterilization validation).
  • Turning on CEP/DMF for API adds checks for CEP/DMF verification.
  • Combination products (≥2 APIs) trigger extra controls (ratios, compatibility, specs per API).

FAQ

Does the module auto-save?
No. Export JSON regularly to keep your progress and import it next time.

Is this a legal substitute for regulatory review?
No. This is an assistant tool. Final compliance decisions remain with your RA/QA professionals and applicable laws/guidelines.

Browser recommendation?
Latest Chrome or Edge with full Vietnamese font support (even if using English UI).

Official Pages

How to resume later: Sign in at www.pharmapp.vn → open TT 12/2025 Dossier Assistant (CTD/ACTD) → select tt_12_v2 → Import JSON → continue working and Export when done.


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