Post-approval Filings

1. What this module does

You list each change with its US category (annual report, CBE-0, CBE-30, prior approval supplement) or EU type (IA, IA_IN, IB, II), the EU classification code, the implementation date, the present and proposed text, the conditions met and the documentation.

The tool works out the annual report due date from the approval anniversary, checks EU Type IA timing (within 12 months; IA_IN within 14 days), flags any IB or II change already implemented, and writes the US and EU documents.

What you get

• US: annual report CMC section (21 CFR 314.81(b)(2)) with the stability update, and supplement summaries.
• EU: variation application present/proposed table with conditions and documentation.

2. Before you start

Have these ready. You can still start with the example data and replace it piece by piece.

• Approval date and reporting period.
• Each change with category, EU code, date, present and proposed text, conditions and documentation.
• Stability batches and time points reached in the period.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/post-approval-filings.html. The example is loaded when the page opens, so every panel already has realistic data. Follow the steps to see how it works, then replace the example with your own data.

1. Describe the product and period

   Choose the regions, enter the application number, approval date, reporting period and planned submission date.

   

2. List the changes

   One row per change and region: a change filed in both regions takes two rows, one with the US category and one with the EU type.

3. Read the result

   The headline counts the changes per filing: "2 annual report changes · 3 EU variations". The note gives the annual report due date.

   

4. Resolve alerts and download

   Late Type IA notifications, IB or II changes with an implementation date and a missing stability update are flagged. Then preview and download.

   

4. Field reference

Every input in the tool, panel by panel. Tables accept rows pasted straight from Excel, comma-separated text, or a loaded file; check the columns after loading a file. Fields marked “when it applies” appear only for the choices that need them.

1 · Product and period

2 · Changes

Category: AR, CBE-0, CBE-30, PAS (US) or IA, IA_IN, IB, II (EU). EU code from the Variations Guideline, for example B.II.b.4.a. Conditions met: the condition numbers, or "all".

5. Checks and alerts

Calculations and pass/fail outcomes always come from fixed rules, never from AI. The tool checks:

• US annual report due within 60 days of the approval anniversary.
• EU Type IA within 12 months of implementation; IA_IN immediately (within 14 days).
• A Type IB or II change, or a US prior approval supplement, must not be implemented before approval: critical.
• Present and proposed text and documentation for each EU variation.

How to resolve alerts

• Critical alerts block the download and must be fixed in the data. A failing result can instead be linked to an investigation: type the investigation reference and outcome and press Record.
• Major alerts block the download until you fix them or type a justification and press Accept justification.
• Minor alerts do not block anything. They are listed in the documents so the reviewer sees them.
• Some alerts have an Apply fix button that makes the change for you. Reopen undoes a justification.

Narratives

This module writes: Summary of CMC changes. Each narrative is written by fixed rules from your data. You can edit it in the box. Rewrite with AI (where your plan includes AI) rewrites it in regulatory style; every number in the text is checked against your data, and a number that does not match is flagged under the box and blocks the download until you correct it. Reset to rule-based text brings back the original.

6. Preview, gap review and download

1. Press Preview next to a section, or Preview and download all. The document opens in a preview window, exactly as the Word file will read.
2. The left side lists the review, run on your device: gaps in the data (missing values, open alerts), gaps in the report (missing content the guidance expects, placeholders such as [site] or TBD left in the text) and, if you load the approved protocol under Compare with the protocol, differences from the protocol (requirements, criteria, batches or time points it plans that the report does not show).
3. Click a finding to jump to the place in the preview. Fix it in the tool, then preview again.
4. Optional AI review: a second read for contradictions, claims without data and vague wording. The report text is sent to Claude only when you press it, and only where your plan includes AI. Check every AI finding; AI can be wrong.
5. Press Download Word (.docx) or Download PDF. With several documents open, All as Word (.zip) and All as PDF (.zip) download the set. The download buttons stay disabled while a blocking alert is open; the preview still works.

Documents this module produces

Use Save project to keep your work as a file on your computer, and Open project to continue later. Start blank clears every field; Load example brings the example back. Nothing is stored on CMCfy servers.

7. US and EU submissions

US follows 21 CFR 314.70, 314.81(b)(2) and 601.12, and the FDA guidance on changes to an approved NDA or ANDA. EU follows Regulation (EC) No 1234/2008 and the classification guideline (2013/C 223/01).

8. Working with other modules

• Classify planned changes first in the Post-approval Change Classifier module.
• GMP change assessment is done in Change Control.

9. Common pitfalls

• Listing a change implemented under IB or II before approval.
• Missing the 14-day window for an IA_IN.

10. Practice exercises

Each exercise starts from the example (press Load example to reset). We run these on every update of this guide, so the result you see should match.

1. Change the packaging site to a Type II

   In the changes table, change the category of the new secondary packaging site from IA_IN to II.

   Expected resultA critical alert says a Type II change has an implementation date.