International Filings (Japan, Canada, WHO)

1. What this module does

You choose the agency and enter the sites, the manufacturing steps with their parameters, the specification and the stability data. The tool writes the document in the layout that agency expects.

For Japan, critical parameters become approval items (a change needs a partial change application) and the rest are marked 『 』 as minor change notification items. The tool checks stability against the climatic zone (25 °C/60% RH for Japan and Canada, 30 °C/75% RH for WHO), the pharmacopoeias the agency accepts, the master file and the site registrations.

What you get

• A Word or PDF document: Japan approval matters (Module 1), Health Canada CPID, or WHO QIS.

2. Before you start

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

• Manufacturing sites with their accreditation, DEL listing or inspection status.
• Process steps with the critical parameters and ranges.
• The specification, stability data and the drug substance master file or CEP.

3. Step by step with the example

Open the tool at app.cmcfy.com/app/international-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. Choose the agency

   Choose Japan, Canada or WHO prequalification, the submission type and the drug substance reference.

   

2. Enter sites, process and specification

   One row per site, per process parameter and per test. Write "yes" in the last process column for critical parameters.

3. Read the result

   The headline gives the outcome: "Quality Information Summary (QIS) ready for WHO prequalification".

   

4. Resolve alerts and download

   Missing long-term data at the zone condition is critical. Pharmacopoeias the agency does not accept, missing site registrations and a foreign reference product for Canada 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 · Submission

2 · Sites

3 · Manufacturing method

One row per step and parameter. Critical: yes for parameters that affect quality (these become partial-change items in Japan).

4 · Specification and stability

5. Checks and alerts

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

• Long-term stability at the zone condition, months and batches.
• Pharmacopoeias accepted by the agency.
• Master file or CEP, site registrations and the reference product.

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. 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

The US/EU switch does not apply here: choose the agency in the tool. Japan follows the PMD Act and MHLW notifications; Canada the Health Canada Quality guidance for NDS and ANDS; WHO the TRS 970 Annex 4 dossier guideline.

8. Working with other modules

• US and EU Module 1 items are prepared in Regional Information (3.2.R and Module 1); post-approval changes in Post-approval Filings.

9. Common pitfalls

• Filing for WHO with only 25 °C/60% RH long-term data.
• Putting every Japanese parameter in 『 』, which the PMDA will not accept for critical parameters.

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. Switch to Japan

   Choose Japan as the agency.

   Expected resultThe headline shows that the methods citing Ph. Int. are not accepted in Japan.