Regulatory change monitoring for every agency and every market, with six agents reading and one lead deciding
Every agency change reaches the right team within hours, translated and cited.
See one case, screen by screen ↓There is no single place where the world’s health authorities publish. FDA guidance and Federal Register notices, EMA guidelines and PRAC outcomes, MHLW safety notices in Japanese, NMPA announcements in Chinese, ANVISA resolutions in Portuguese — each on its own site, in its own format, on its own schedule. Someone has to check them all, every day, and nothing tells them when they missed one.
Finding the change is only the start. It has to be translated, read, summarized and checked against every product and market licence, the labeling plan and the submission calendar, then sent to the team that owns it. Done by hand, that chain is slow, error-prone and often late: a notice that moves a package insert deadline forward by ten weeks can sit in an inbox while the comment period or the filing window runs down.
Estimated split of the 7.6-day median by hand and the 3.4-hour target with the agents, in elapsed hours.
Six specialist agents watch, translate, summarize and assess every update; a regulatory lead confirms the impact.
Tuesday, 6 October 2026. This week MHLW issued a safety notice for veltrimab in Japanese, and EMA opened a public consultation on the quality of drug–device products. Both are in the morning digest. Here is what happens next, screen by screen, in the working solution.
Dana opens the solution to 27 new updates across 9 agencies, 5 of them High impact for 3 of her products, and 13 High and Medium updates waiting for her confirmation. The overnight watch shows each step: 64 sources checked, 41 changed pages found, 9 documents translated, 27 updates summarized, impact proposed for 4 products.
“Proposed impact for 4 products — 5 High · 8 Medium · 10 Low · 4 not relevant.”
The Updates list carries the agency, the impact, the products touched, the stage and the deadline for each item. Japanese, Chinese and Portuguese titles appear in English with the original kept underneath — “translated from Japanese” — and the deadlines that fall inside 60 days are marked.
The draft Guideline on quality documentation for medicinal products used with a medical device opens beside a four-line summary, each line linked to its passage. The planned switch to an autoinjector (variation filing Q2 2027) would need a Notified Body Opinion — High, 92 % confident. The marketed prefilled syringe gets Medium for its 2019 usability summary. Talmirex and Corventa are Not relevant, each with the reason.
Proposed by the Impact assessor · High · 92 % confident · needs your signature.
Dana asks in plain words. The assistant searches 4,812 updates and 3 internal plans, reads the MHLW notice in Japanese and checks the labeling plan. Yes: the notice wants the revised Veltrimab electronic package insert on the PMDA website by 1 December 2026, while the labeling plan puts it in the February 2027 cycle (row JP-14). The EU asks for a variation on the same signal, also due 1 December.
“Yes — it moves the Japan label update for Veltrimab forward by about 10 weeks.”
“Open the notice at this passage” lands on page 2 of 医薬安発1002第1号, the original paragraph next to its translation, with the deadline highlighted. The summary says what MHLW asks: add interstitial lung disease to section 11.1, Clinically significant adverse reactions; post the revised package insert by 1 December; inform healthcare professionals promptly.
The original text is always kept next to the translation.
Japan is High at 95 %. Globally, Medium at 88 %: the same signal is under PRAC review, so the company core data sheet should add interstitial lung disease and every market moves together. Three actions are drafted with owners and dates — the revised package insert by Dr. Maya Chen, the core data sheet by Lena Ortiz, the letter to healthcare professionals by Kenji Mori.
Dana checks both impact levels and the three teams to notify, chooses the meaning of her signature — “I confirm this impact assessment” — and enters her password. Her name, the date, the time and the meaning go on the audit trail.
The update moves from New to Assessed. Japan affiliate, Global labeling and Japan medical affairs are notified in Japanese and English, with the original document attached. Nothing went out before the lead signed.
“Confirmed and signed by Dana Okafor · 6 Oct 2026, 09:14 CET.”
The activity trail of the update reads like a log: the Agency watcher found it on pmda.go.jp at 05:04, the Translator translated it from Japanese at 05:07, the Summarizer wrote the summary at 05:09, the Impact assessor proposed High at 05:11 — and Dana confirmed at 09:14, with 3 teams notified.
The dashboard counts the updates read from 64 sources in 38 countries, the hours saved against reading and logging by hand, and the time from publication to the owning team — 3.4 hours median against 7.6 days by hand in 2025. Every High and Medium impact was confirmed by a named lead before teams were notified.
The same morning’s updates, seen by the five people who act on them — what their week looked like, and what it looks like now.
Six specialist agents watch, translate, summarize and assess every update; a regulatory lead confirms the impact.
Checks 64 agency sources every morning at 05:00 CET and collects anything new or changed — guidance, notices, regulations, safety communications — dropping duplicates it has already seen.
Translates Japanese, Chinese, German, Portuguese, French, Korean and more into English, paragraph by paragraph, keeping the original side by side.
Writes three to five short lines for each update — what changed, for which products or devices, and by when — and records the key dates: published, comments close, effective.
Compares each update with every product and market licence in the portfolio register, the labeling plan and the submission calendar, and proposes High, Medium, Low or Not relevant per product, with the reason and its confidence.
At 07:00 local time, sends each team its digest — confirmed High and Medium impacts first, with the reason, the deadline and the owner of each action — in the team’s own language.
Answers questions in any language across all updates and the internal plans, citing the exact page for every statement, with the original passage and its translation.
Confirms each impact. The agents propose; a named person decides.
Answers come from 4,812 agency updates and your internal plans. Every line links to the exact page, with the original text and a translation.
Does the new PMDA notice change our labeling timeline?
Yes — it moves the Japan label update for Veltrimab forward by about 10 weeks. The notice adds interstitial lung disease to section 11.1, and the revised electronic package insert must be on the PMDA website by 1 December 2026. Your labeling plan puts this update in the February 2027 cycle. The EU asks for a variation on the same signal, also due 1 December.
Is the PRAC signal for Veltrimab linked to the PMDA notice?
Yes — both act on the same signal: interstitial lung disease with veltrimab. The EU asks for a Type II variation to SmPC 4.4 and 4.8, Japan for section 11.1 of the package insert, both by 1 December 2026. One update to the company core data sheet keeps both labels — and the other markets — aligned. Lena Ortiz owns the EU variation; Dr. Maya Chen owns the Japan package insert.
Which updates this week affect Corventa?
Four, one High. FDA’s revised draft guidance asks for 5-year follow-up in pivotal trials, where your PMA supplement plans 3 years. NMPA self-test reports for Class III devices need calibration certificates from 1 March 2027. NMPA’s draft stent guideline accepts overseas data with at least 15 % Chinese patients. MHRA periodic safety update reports become yearly for Class IIb and III devices.
What do this week’s updates mean for Lumora?
One High-impact change in Japan: app-connected glucose monitors must meet JIS T 81001-5-1 for cybersecurity, so the May 2027 app release must show conformity. In the UK, periodic safety update reports become yearly. An FDA cybersecurity alert concerns a Bluetooth library Lumora does not use — no action.
13 screens from the working solution, on its sample data. Pick one to see it large.
What is watched, who confirms and how hard each change counts are settings, not a project.
| Setting | Default | Choose from |
|---|---|---|
| Watched sources | 64 sources · daily 05:00 CET | Add a source · switch any off |
| Who confirms High and Medium impacts | One named lead per area | Biologics · Small molecules · Devices · Japan · Cross-product and policy |
| Any labeling change for a marketed product | At least High | High · Medium · Low |
| Clinical evidence change for a Class III device | At least High | High · Medium · Low |
| Submission format or variation category change | At least Medium | High · Medium · Low |
| Fees, meeting notices and other companies’ approvals | At least Low | High · Medium · Low |
| Daily digest send time | 07:00 local time | 06:00 · 07:00 · 08:00 local time |
| Digest language | Team’s own language | Team’s own language · English for everyone |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample data · “target” = the design goal, measured in the live solution · “estimated” = our estimate. People named on this page are characters in the working solution; Veltrimab, Talmirex, Corventa and Lumora are its sample products, and the agency documents shown are its sample data.
Software that watches health authority websites for new and changed guidance, regulations, notices and safety communications, and tells regulatory teams what each change means for their products. Regulatory Intelligence does it with six agents that watch, translate, summarize and assess every update, and a named regulatory lead who confirms the impact.
In the working solution, 64 sources in 38 countries every morning at 05:00 CET — among them FDA, EMA, PMDA / MHLW, NMPA, MHRA, Health Canada, TGA, Swissmedic, ANVISA and the European Commission’s Medical Device Coordination Group, plus notified bodies, standards bodies and national agencies. You can add a source in Settings.
Yes. The Translator works paragraph by paragraph from Japanese, Chinese, German, Portuguese, French, Korean and more, using a regulatory glossary for regulated terms, and always keeps the original text beside the translation. Affiliates can read their digest and ask questions in their own language.
The Impact assessor checks each update against every product and market licence in your portfolio register, your labeling plan and your submission calendar. It proposes High, Medium, Low or Not relevant per product, gives the reason with a link to the passage, and states its confidence. Your impact rules set the minimum level for each kind of change.
Yes. Every High or Medium impact is confirmed and signed by a named lead before any team is notified, and the agents never confirm. Low and Not relevant updates are filed automatically, with 10 % sampled for review each week.
Yes. Every summary line, impact reason and answer links to the exact page of the agency document, with the passage highlighted and, for documents not in English, the original next to the translation. When nothing answers a question, the assistant says so.
Once the lead confirms, the Digest writer sends each team its note in its own language with the original attached, and builds the daily digest for 07:00 local time. Team actions carry an owner and a due date, and the impact board shows where each one stands.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your product portfolio register, labeling plan, submission calendar and the sources you watch — and it goes live once every quality gate has passed. We will show it to you on your own portfolio first.
Module 2 summaries drafted in weeks, every statement cited to its source page.
1-min filmAgency ResponsesEvery agency question gets a cited first draft within hours, consistent with every past answer.
1-min filmLabel Change CascadeEvery core data sheet change finds each local label it touches and puts every market on a clock from day one.
1-min filmWe’ll run Regulatory Intelligence against your own products, markets and agency sources.