On September 10, 2026, the European Commission Directorate-General for Health and Food Safety published an updated list of joint clinical assessments under Article 30(3)(h) of Regulation (EU) 2021/2282. The Commission announcement hosts the official workbook, stamped "Data extracted on 10 September 2026", which is the public control file for every medicine now in an EU-level Joint Clinical Assessment (JCA).
This drop refreshes the register, not the legal framework. The ongoing tab lists 16 medicinal products whose marketing authorisation applications have been validated by EMA, or are under EMA phased review, and for which the Subgroup for Joint Clinical Assessments has appointed an assessor and a co-assessor. Four JCAs are completed. Three remain discontinued. Appearance with a named pair is the operational start of that product's joint assessment.
What did the Commission put on the public record on September 10?
The announcement page offers the Excel file hta_ongoing-jca_en.xlsx (82.49 KB). A product appears only once EMA has validated the marketing authorisation application and an assessor and co-assessor have been appointed. Rows leave the ongoing tab when the Member State Coordination Group on Health Technology Assessment (HTACG) endorses the report and the Commission publishes it, or when the JCA is discontinued.
The completed tab, extracted on September 7, 2026, now includes onasemnogene abeparvovec (Itvisma), published that day, plus tovorafenib (Ojemda), tarlatamab (Imdylltra) and lurbinectedin (Zepzelca). The discontinued tab is still extracted as of June 24, 2026: sasanlimab (MAA withdrawn on February 13, 2026), plus catequentinib and Tacquell, both discontinued on June 22, 2026 because the JCA dossier failed Article 9(2), (3) and (4), triggering Article 10(6).
None of the 16 ongoing files is a type II variation adding a new therapeutic indication under Annex II, point 2(a), of Regulation (EC) No 1234/2008. Four are ATMPs. Six are orphan-designated. Only lunsotogene parvec is on an accelerated EMA timetable under Article 14(9) of Regulation (EC) No 726/2004. Daraxonrasib is the only ongoing file marked "Under EMA phased review" instead of a calendar validation date.
Which products joined the ongoing tab most recently, and who assesses them?
By EMA validation date, these are the newest ongoing appointments in the September 10 extract:
| INN | Indication | Assessor | Co-assessor | EMA validation |
|---|---|---|---|---|
| Cosibelimab | Cutaneous squamous cell carcinoma | IQWiG (DE) | HAS (FR) | May 21, 2026 |
| Lunsotogene parvec | OTOF hearing loss (ATMP, accelerated, orphan) | G-BA (DE) | NOMA (NO) | May 21, 2026 |
| Rezvilutamide | High-volume mHSPC | ZIN (NL) | NCPE (IE) | June 18, 2026 |
| Mezigdomide | Relapsed or refractory multiple myeloma | IQWiG (DE) | AOTMiT (PL) | June 18, 2026 |
| Daraxonrasib | Metastatic pancreatic adenocarcinoma (orphan) | IQWiG (DE) | Danish Medicines Council | EMA phased review |
| Living bilayered bioengineered skin | Deep dermal and full-thickness burns (ATMP, orphan) | HAS (FR) | NIHDI (BE) | July 16, 2026 |
| Bifikafusp alfa / onfekafusp alfa | Neoadjuvant melanoma | TLV (SE) | AOTMiT (PL) | August 13, 2026 |
The remaining ongoing files, validated between June 19, 2025 and March 26, 2026, are camizestrant, senaparib, relacorilant, ensartinib, zopapogene imadenovec, sintilimab, sonrotoclax, taletrectinib and zamtocabtagene autoleucel. IQWiG is assessor or co-assessor on six of the 16 files.
Who has to act, and does this drop create a new deadline?
Developers whose INN is on the ongoing tab must engage the appointed pair, file a JCA dossier that meets Article 9, and run the assessment in parallel with the centralised procedure under Regulation (EC) No 726/2004. A JCA is a shared evaluation of relative clinical effects, not a pricing or reimbursement decision; those stay national. Member States that are not the assessor or co-assessor owe due consideration only once a report is published. For these 16 files that duty has not yet crystallised.
The drop does not amend HTAR dates. JCAs have been mandatory for cancer medicines and ATMPs since January 12, 2025. They become mandatory for all orphan medicinal products from January 13, 2028 and for all medicines from January 13, 2030. What it restarts is the product-level clock: Article 10(6) already discontinued catequentinib and Tacquell for incomplete dossiers, with no effect on EMA's own timetable. Completeness against Article 9(2), (3) and (4) is a live discontinuation risk for every originator now on the ongoing tab.
What should JCA and market-access leads do this week?
Download the September 10 workbook and map every asset in the 2026-2027 EU launch sequence against the 16 ongoing INNs, the four completed reports and the three discontinued files. If you are on the ongoing list, confirm the assessor and co-assessor, the PICO scoping status, and whether the Article 9 dossier would survive an Article 10(6) completeness check. Brief HEOR and pricing teams in Germany, France, the Netherlands, Ireland, Sweden, Poland, Denmark, Belgium and Norway that named bodies are now locked as assessor or co-assessor on live files.
A continuous, per-jurisdiction real-time monitoring setup surfaces each Commission HTA register refresh the moment DG SANTE posts it, so dossier teams do not learn of an assessor appointment from a competitor's newsletter.
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Confirm whether any product in your sequence sits on the 16-row ongoing tab. Download the workbook and the four completed reports. Brief the appointed national pair and your EU market-access lead before the next monthly extraction. Obsidian keeps the HTAR JCA lineage current from EMA validation through assessor appointment to publication, so the next move is a dossier decision, not a search.
