Health authority safety questions answered on time, cited, and in line with what you said before
Every safety question from an authority answered on time, cited and in line with past answers.
See one case, screen by screen ↓A PRAC request for supplementary information, an FDA safety labeling change notification, an MHRA or PMDA inquiry — each arrives with its own due date and its own procedure number. The safety physician owns the answer, but the facts sit in a dozen places: the safety database, the last PBRER and DSUR, the RMP, the CCDS, committee minutes, and every response the company has already sent.
Most of the days go on finding and checking, not on judgement. Someone runs the SMQ query and builds the case series; someone hunts down what was said to which authority, and at which data lock point; the writer drafts and cites by hand. The quiet risk is the answer that contradicts an earlier one — a 2024 response that said there was no Hy’s law case, sitting next to a new draft that reports one — and nobody notices until the assessor does.
Estimated split for a typical cumulative-review request, by hand and with the solution. Review and sign-off stay with people, so they shrink the least.
Six specialist agents read the letter, gather the evidence, draft and check every answer; the safety physician and QPPV decide and sign.
PRAC asks Northwind Bio for a cumulative review of liver injury with Veltrimab, due 9 November 2026. Here is how the response comes together, screen by screen, in the working solution.
Maya opens the runway: 7 open requests from 6 authorities, 15 questions to answer, 3 due in the next 14 days — the nearest MHRA on Oct 15 — and 1 conflict with an earlier answer. Each request sits in its authority’s lane with its stage and due date, and a diamond marks the internal draft date 10 days before the deadline.
“HA-1042 · Veltrimab — Drug-induced liver injury. EMA · PRAC · 1 conflict with an earlier answer · 4 drafts ready.”
A Health Canada letter on Talmirex and medication overuse headache has come in through the submission gateway inbox. Maya presses “Process the letter”: the letter reader splits it into 3 questions and sets the Nov 6 clock, the case series builder runs query QR-88262 and finds 31 reports, and the drafter writes 3 answers with 6 citations. The position checker finds the 3 claims consistent with PBRER #4 and the product monograph.
Every step is shown as it runs, with what it found and how long it took.
HA-1042 is a signal request for supplementary information, EPITT 20418. The letter reader took the authority’s four questions exactly as written — the cumulative review and Hy’s law cases, time to onset and dechallenge, observed versus expected, and the SmPC and RMP — and read the 9 November 2026 due date from the letter itself.
The due date is read from the letter, never guessed, and the authority’s wording is never changed.
Query QR-88217 searched the safety database with the SMQ “Drug related hepatic disorders – comprehensive search” (broad), MedDRA 29.0, from the international birth date to the 31 August 2026 data lock point: 214 cases, 61 serious, 9 duplicates removed. Three cases met the laboratory criteria for potential Hy’s law; two had an alternative cause — acute hepatitis E and a paracetamol overdose. One, from the VLT-302 open-label extension, had none.
Dana Okafor, the safety scientist, approved the case series before the drafter used it.
The drafter wrote the four answers in the company’s response style. Each sentence carries a numbered citation; click it and the evidence panel shows the passage highlighted — the query record, the cumulative line listing, the Hy’s law screen, the case narrative. Where the facts have not changed, it reuses approved wording from earlier answers.
The position checker lined up the 6 claims in the draft against 14 earlier statements: 2 consistent, 2 changed with new data, 1 approved position change and 1 conflict. In March 2024 the company told PRAC that no case meeting Hy’s law criteria had been identified, and PBRER #6 said the same. The draft now reports one. Until a person decides, “Approve and send for sign-off” stays locked.
“Both earlier statements were accurate at their data lock points … Update the position and say what is new, so PRAC sees why the answer changed.”
Maya has three choices: update the position and explain what is new, return the draft to the writer, or take it to the Safety Management Team. She updates it. A new section appears in the answer to Q1 — “What is new since our earlier answers” — saying the 2024 statement reflected the data lock point of 31 December 2023, and that the new case was reported on 12 June 2026 and disclosed in DSUR #7.
The sign-off screen shows 4 answers, 17 citations and 0 open conflicts, with the consistency report: 6 claims checked against 14 earlier statements, 1 conflict explained by her, 1 position change approved by the Safety Management Team. She signs with her password and the meaning of the signature — “I approve this response as the responsible safety physician” — and it goes to Omar Haddad, the EU QPPV, for the second signature.
Once both have signed, the package assembler builds the submission in CTD order: a cover letter to the PRAC rapporteur, the response to questions 1–4, the cumulative line listing in CIOMS II format, narratives of the 61 serious cases, the Hy’s law narratives, references, the consistency report and the approval record. Lena Ortiz, regulatory affairs, submits it through the EMA gateway on Oct 7, ahead of the Nov 9 deadline, and Veltrimab’s liver-safety position moves to version 4.
“Submitted before the Nov 9 deadline · receipt EMA-ESG-20261007-118842.”
The same PRAC question, seen by the people who carry it — what their weeks looked like, and what they look like now.
Six specialist agents read the letter, gather the evidence, draft and check every answer; the safety physician and QPPV decide and sign.
Reads the authority letter — authority, procedure, product, due date and each numbered question — starts the clock and assigns the product’s safety physician and writer. Flags anything that asks for a label change.
Finds the passages that answer each question in prior responses, PBRERs, DSURs, RMPs, CCDS, labels, committee minutes and literature.
Runs the safety database query with the right MedDRA SMQ, removes duplicates, screens for Hy’s law, and computes exposure, reporting rates and observed versus expected.
Writes each answer in the company’s response style, sentence by sentence with numbered citations, reusing approved wording from earlier answers where the facts have not changed.
Lines up every claim in the draft against everything the company has told any authority, and sorts it: consistent, changed with new data, conflict, or approved position change.
Builds the submission package — cover letter, response document, line listings, narratives and references in CTD order — and hands it to regulatory affairs to submit.
Decide conflicts and sign. The agents propose; a named person decides.
Anyone on the safety team can ask about an open request, a clock, or what the company has said before — and every answer is cited.
What have we told regulators about Veltrimab and the liver?
Four statements, oldest first: March 2024 to PRAC, no Hy’s law case in the clinical programme; April 2026 in PBRER #6, 183 cases, no Hy’s law case, not a risk; July 2026 to Health Canada, a serious hepatic rate of 0.31 per 1,000 patient-years; August 2026 in DSUR #7, one potential Hy’s law case under evaluation. The Safety Management Team approved a change on Oct 5: drug-induced liver injury as a rare side effect and an important potential risk.
Summarise the Hy’s law cases in HA-1042
Three cases met the laboratory criteria: NWB-2025-118204 (ALT 8.2×, bilirubin 3.1×, hepatitis E), NWB-2026-007731 (22.5× and 4.0×, paracetamol overdose) and NWB-2026-041877 (11.4× and 2.6×, no alternative cause found — causality possible). The third, from the VLT-302 extension, resolved after stopping Veltrimab. It is why the draft conflicts with the 2024 PRAC answer.
Which requests are at risk of missing their deadline?
Three are due in the next 14 days. The tightest is HA-1044 (MHRA, Oct 15) — it only needs Omar Haddad’s signature. HA-1045 (PMDA, Oct 21) is still gathering evidence; a reminder to Dana Okafor today is suggested.
Add a rule: flag any number that differs from the last PBRER
Done. New consistency rule: any number in a draft that differs from the latest PBRER is flagged, unless the draft names the newer data lock point. It applies to every open request from now on, is recorded in the audit trail, and can be switched off in Settings.
13 screens from the working solution, on its sample data. Pick one to see it large.
Clocks, what a draft is checked against, who clears a conflict and who signs second are all settings.
| Setting | Default | Choose from |
|---|---|---|
| Internal draft due | 10 days before the authority’s deadline | Set in days, up or down |
| Warn regulatory affairs about an extension | 5 days before | 5 · 7 · 10 days before |
| Clock calendar | Calendar days (authority rule) | Calendar days · Working days |
| Compare every claim against | All six sources | Prior responses · PBRER and PSUR · DSUR · RMP · CCDS and labels · Safety team minutes |
| Numbers that change with a new data lock point | Explain automatically | Explain automatically · Always ask me |
| Who can clear a conflict | Product safety physician | Product safety physician · Any safety physician · Head of Patient Safety only |
| Changes of position | Safety Management Team approves | Safety Management Team approves · Head of Patient Safety approves |
| Second signature for EU procedures | Omar Haddad (EU QPPV) | Omar Haddad (EU QPPV) · Dr. Jonah Reyes (Head of Patient Safety) |
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 · “typical” = published rules and figures (FDA 505(o)(4) safety labeling changes — 30-day clock; see also Deloitte, Transforming pharmacovigilance (2022), and the EMA Q&A on signal management). People and products named on this page are characters in the working solution.
It handles safety questions from regulators — PRAC signal and PSUSA requests, FDA safety labeling change notifications, MHRA, PMDA, Health Canada, Swissmedic and TGA requests — from the arriving letter to a signed, cited response. Six agents read the letter, gather the evidence, build the case series, draft, check every claim against earlier answers and assemble the package; the safety physician and QPPV decide and sign.
The position checker takes every claim in a draft and finds every earlier statement on the same product and topic — prior responses, PBRERs and PSURs, DSURs, RMPs, CCDS and labels, and safety team minutes. It sorts each one as consistent, changed with new data, an approved position change, or a conflict. Number changes it can explain by data lock point; anything else goes to the safety physician to decide.
No. The case series builder runs read-only queries and never edits case data. Each number it produces keeps its query record — SMQ, MedDRA version, period and data lock point — and a safety scientist approves the case series before the drafter uses it.
Yes. The working solution tracks an FDA safety labeling change notification for herpes zoster, which asks for a labeling supplement or a rebuttal statement within 30 days of the letter. Its draft accepts FDA’s wording as a changes-being-effected supplement, citing the notification and the current section 5.3. The safety physician decides, and the FDA liaison signs second.
Yes. The agents draft and check; people decide. A conflict with an earlier answer can only be cleared by a named safety physician, a change of position needs Safety Management Team approval, and every response is signed by the safety physician and then a second named signer before anything is packaged.
The letter reader reads the due date from the letter and starts the clock. Each request shows its days left and an internal draft date ahead of the deadline. Regulatory affairs is warned when a request is close to its deadline and not yet in review. Whether days count as calendar or working days is a setting.
Your submission gateway inbox, safety database, document management for PBRERs, DSURs, RMPs, CCDS and labels, your library of past responses, the regulatory information system and a literature service for background rates.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your response style, past responses and safety documents — and it goes live once every quality gate has passed. We will walk you through it on your own past authority letters first.
Every side-effect report becomes a cited case in minutes, filed with days to spare.
1-min filmSafety LiteratureEvery journal article screened with a written reason, and reportable cases at intake in about a day.
1-min filmSignal ManagementEvery potential safety signal gets its evidence assembled in days, each number traced to its query.
1-min filmWe’ll run the Safety Query Responder on a sample of your own past authority letters.