Pharmaceutical GMP · quality regulatory newsWeekly News — Vol. 18
Global Regulatory Monitor

Every regulatory signal,
in one place.

Cut the hours spent gathering regulatory information down to one weekly page. Key facts, implications, and practical check points on a single page, ready to use the moment it is shared.

FactInsightCheck
12regulatory sources
Weeklypublication
A·B·Cevidence grades
100%source traceability
Coverage — 12 sources
FDAEMAEudraGMDPMHRAPIC/SICHMFDSWHOHealth CanadaECAISPEOpenFDA
What it does

From data collection to check items.

01

Automatic collection from global sources

Key regulatory news from FDA Warning Letters and 483s, OpenFDA (open data) and recalls, EMA, MHRA, PIC/S, ECA, MFDS, ICH, WHO, Health Canada, and more, collected automatically every day.

02

Fact separated from interpretation

Objective facts are kept as written in the source, and editorial insight is clearly set apart by colour and position.

03

Evidence and signal grading

Every card carries an evidence grade (A, B, C) and a signal tier (1–3) at a glance, to help you set priorities.

Evidence A Signal T3
Findings Database

Where the weekly brief comes from — the sentences actually cited in inspections

Look up the source records the brief summarises. 4,960 documents and 23,398 findings extracted from FDA 483s, Warning Letters, Canadian and EU inspection reports, and MFDS actions (as of 2026-10-20 — the search page shows today's figures).

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Weekly Quiz

This week's regulatory quiz takes three minutes.

A short review of regulatory and quality terms and recently published cases. Pick an answer and see the correct answer, explanation, and source link immediately. No leaderboard — the more you solve, the more Gurumi grows.

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Reference Library

The reference material is always in the library.

GMP guidance, notices, and standards from Korean and international regulators, in 11 catalogues by agency with 534 items in total. Every item links to the official source, refreshed automatically each Monday.

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Firm Watchlist

Get new findings for your watchlist companies by email.

Add partners and competitors to your watchlist and we gather newly published findings into a weekly email. Free members can search a company by name and add it right from its page.

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Weekly Newsletter

New GMP inspection findings, every Monday

Every Monday we email the week's new inspection records from the FDA, EMA, Health Canada and MFDS, with a short summary of the week's regulatory news. We'll also let you know when the site gains new features. Unsubscribe any time with one click.

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AI Disclosure

How this content is produced, and caveats

This service regularly collects and analyses public material from major regulators and authoritative expert bodies — FDA, EMA, MHRA, PIC/S, ICH, WHO, Health Canada, ECA, MFDS, and others — and presents it as briefing cards generated with generative AI.

Figures, codes, dates, quotations from the original text, source links, and machine-extracted tables are taken from the source and are displayed separately from the generative-AI summary.

Each item is classified by evidence grade (A, B, C) and signal tier (1–3) and comes with its source and a link to the official document, so you can trace and verify it against the primary material.

This service is reference material to support awareness of regulatory trends and quality issues. The summaries, analysis, and interpretation do not represent the views of any regulatory authority and must not be taken as legal, regulatory, quality, or compliance advice or as a certification opinion. Review important decisions against the official source and with professional advisers.