See what EMA accepted for products like yours
Workbench reads published EPARs, the Union Register and national registers, and cites what each one records. Atlas holds your own procedures, and Alerts flags the routes that open in other markets once a product is approved.
Precedent research means reading EPARs page by page
Before a response or a filing decision, someone opens each EPAR for the molecule, finds the relevant discussion and copies it into a spreadsheet. Holders and status are checked in the registers one country at a time. The next question starts the same search again.
Built on the source
Every line traced to its source
Answers are written from the sources retrieved for the question, not from model memory. Here is a CMC answer, claim by claim.Tightening the limit is a Type IA variation in the EU. [2]
Notify within 12 months of implementing it. [1]
In the US it goes in the annual report. [5]
The approved limit is Q = 75% at 45 min. [D1]
- [1]Regulation (EC) No 1234/2008Article 8 · Type IA notificationsEUR-Lex
- [2]Variations classification guidelineChanges to finished product specificationsEudraLex
- [5]Changes to an approved NDA or ANDASpecifications · annual report changesFDA Guidance
- [D1]change-control-cc-2291.pdfPage 3 · current dissolution limitYour document
- US FDA 8
- EU & EMA 9
- ICH & standards 6
- National agencies 5
- Global regulators 4
- Terminology 4
- HTA bodies 3
- Clinical & literature 2
- Your documents
From published EPARs to a cited comparison
Workbench reads the public record
Workbench searches EMA EPARs, the Union Register and national registers for the molecule, and cites the document behind each point it takes from them.
Atlas supplies your position
The comparison runs against your Atlas record, such as Denosumab Ostra 60 mg under EMEA/H/C/006588, with three Day 180 issues open and responses due in 70 days.
Alerts flags the next market
Alerts reads new pathways against your plans. ANVISA's abbreviated route for biosimilars approved by EMA matched the planned Brazil filing for Denosumab.
Compare Day 180 issues with published precedent
Atlas shows three Day 180 issues open on Denosumab Ostra 60 mg. Workbench checks what published EPARs record on the same points before the responses are drafted.
What's up next?Our Day 180 list for Denosumab Ostra 60 mg questions extrapolation to all reference indications. What did EPARs for authorised denosumab biosimilars accept, and on what data?
- understanding your question…
Denosumab Ostra 60 mg · EMEA/H/C/006588 · Day 180 outstanding issues
- EPARs record what was accepted for those dossiers. Your own comparability data still decide each issue.
1. Short answer
The EPARs grant the reference indications on a comparative study in postmenopausal osteoporosis, with extrapolation justified by the shared mechanism, RANKL inhibition. Make the same case from your own data.
2. Day 180 issues
3. For the responses
- Answer issue 1 with the extrapolation reasoning the EPARs record, citing each one.
- Set out your comparative ADA data in the same structure as the published reports.
- Keep the three responses on the Atlas timeline, due in 70 days.
Precedents a reviewer can open and check
Cites the EPAR
Every precedent row cites the EPAR or register entry it came from, so a reviewer can open the document and check the wording.
Reads your record
Workbench compares the precedent with your Atlas record: procedure number, open issues and due date, here EMEA/H/C/006588 at Day 180.
Matched to new routes
Alerts reads new national pathways against your planned registrations and names the product that qualifies, such as Denosumab in Brazil.
Related on Regunaut
- Competitor entry dates depend on protection periods: see how data exclusivity changes under the new package.
- Turn the findings into dates with loss-of-exclusivity planning.
Research the precedents for your next procedure
See Workbench, Atlas and Alerts on your own products and markets in a 30-minute walkthrough.