Screen the weekly literature and clock every valid case.

The agent searches PubMed and Europe PMC in their own syntax, adds Embase once it is licensed into your contract, screens each article against the four ICSR criteria and the special situations, quotes the evidence, and puts Day 0 and the due date on every valid case. An inspector can read the search and screening record at any time.

Semaglutide · PubMed · 29 October to 5 November 2026Day 0 = 5 November 2026 · 15-day and 90-day clocks set

Records found

97

Screened in

4

Valid ICSR

1

Full text needed

3

PMID 42439301 · Laryngoscope · case report

Valid ICSR

Revision medialization thyroplasty for glottic insufficiency amid rapid weight loss on semaglutide

Identifiable patient
“A 74-year-old female”
Suspect product
“while taking semaglutide”
Adverse reaction
“marked vocal fold atrophy and glottic insufficiency”
Reporter
The authors, otolaryngology, Weill Cornell, New York

Serious: revision surgery stated, reviewer to confirm · case shell prepared for your database · due 20 November 2026

  • 42964517Pigmented purpuric dermatosis · Compounded semaglutide: check the product is yoursFull text
  • 42957466Cutaneous vasculitis · Case report with no abstract: read the full textFull text
  • 42961329Injection-site amyloidosis · Three GLP-1 agonists named: confirm the suspectFull text

93 screened out: trials, reviews, cohort and laboratory studies. 2 disproportionality analyses passed to signal management.

PubMed records from a KIRHA Search run on 5 November 2026

Part of the surveillance chain:

Leave the reading to the agent.

Most of what a search finds is irrelevant, and the few articles that matter need an expert. The figures below come from the semaglutide run above.

4 of 97

Read the four that matter, not the 97

In one week PubMed listed 97 semaglutide records. Four described an adverse event in a patient. The agent screens every abstract against the four ICSR criteria and quotes the sentence that meets each one. It also records why each of the other 93 was set aside, so your exclusions are as easy to defend as your cases.

3 of 4

Leave the judgement calls to your experts

In the same run, three of the four needed a person: a compounded product that may not be yours, a case report with no abstract, and a case naming three GLP-1 drugs. Each one arrives flagged with the reason, so your reviewers start where their judgement is needed.

Day 0

Start the clock when the search runs

Day 0 is the search date, and the 15-day or 90-day due date is on the case from the start. A case shell is prepared for your safety database, so nothing sits in an inbox between screening and submission.

Any cadence

As often as each product's risk requires, weekly at minimum

Weekly is the regulatory minimum and the default. Run it daily around a launch or a safety issue, or on demand before a PSUR or a signal review. Set it for one product or the whole portfolio.

The same week held two disproportionality studies. They are not cases, so they went to signal management, and the year's relevant articles feed section 11 of the PSUR.

Set it up once per substance.

Then each week the agent runs the search, screens, clocks and records; your reviewer decides.

  1. 01

    Run the versioned search strings on schedule

    Each run is logged with its date and hit count. The strings are yours to review; every change is versioned.

  2. 02

    Screen each new article against the four ICSR criteria

    Checks the patient, reporter, product and reaction, plus seriousness and special situations, and quotes the sentence behind each decision.

  3. 03

    Give each valid case its Day 0 and due date

    Day 0 is the search-run date. The 15-day or 90-day clock starts, and a case shell is prepared for your safety database.

  4. 04

    Accept or reject, with a reason

    The record keeps who decided, when and why. QC sampling is built in.

  5. 05

    Build the records per substance

    The weekly report, the screening record and the search-strategy appendix for the PSUR literature section are ready when the interval closes.

On record

Every run, per substance

  • Run logEvery search, with its date, strings and hit count
  • Screening recordEach article's quoted evidence and decision
  • Case listDay 0, due dates and case shells for your database
  • Weekly reportA summary of each run for your team
  • PSUR section 11 draftWith the search-strategy appendix, per interval

Questions

For a pilot and for substances the EMA literature monitoring service already covers, yes. For a mid-size holder's only search, no: Embase indexes journals Medline does not, and GVP VI names both. Until Embase is licensed into your contract, PubMed runs as a scored second search.

By a case shell your database imports, with the literature reference attached. No write access to your database, no submission. Your case processing stays where it is.

You remain the marketing authorisation holder. What changes is the record: it shows what was searched, when, and why each article was excluded, so the question an inspector asks two years later has an answer.

Start with a tailored analysis of one substance.

Tell us the substance and what you want to see. We run the literature screen on it and walk your team through the results.

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