On September 9, 2026, France's Agence nationale de sécurité du médicament et des produits de santé (ANSM), together with the Institut national du cancer (INCa), the Direction générale de la santé (DGS), the Délégation au numérique en santé (DNS) and the ResOMEDIT, published a package of safety measures for fluoropyrimidine chemotherapy that closes the main gap left by the November 2025 national hospital survey on DPD deficiency screening. The centerpiece is the first national expert opinion harmonising how hospitals adapt the initial dose of 5-fluorouracil (5-FU) and capecitabine for patients with a partial dihydropyrimidine dehydrogenase (DPD) deficiency, a situation each facility previously handled its own way.
Constitutional DPD deficiency sharply alters fluoropyrimidine pharmacokinetics and can trigger severe or lethal toxicities. Pre-therapeutic uracilemia testing before any fluoropyrimidine treatment is already mandatory in France, and a complete deficiency contraindicates the treatment outright. What was missing was a shared rule for the partial-deficiency grey zone, plus reliable decision support in prescription software. Both are now addressed.
What does the national expert opinion change for partial DPD deficiency?
The expert opinion, coordinated by the INCa with the ANSM and the ResOMEDIT, delivers the first shared national framework for adapting the initial fluoropyrimidine dose according to the patient's uracilemia level. Until now, the therapeutic attitude for partial deficiency was not harmonised between healthcare facilities, meaning two patients with the same uracilemia result could receive materially different initial doses depending on where they were treated.
The opinion proposes dose-adaptation propositions for both 5-FU and capecitabine, while stressing that each recommendation must still be weighed against the patient's individual clinical situation. It is published on the INCa, ANSM and ResOMEDIT sites and is intended to be applied immediately as the national reference. The expert opinion is available on the INCa catalogue.
How must chemotherapy-software vendors and hospitals respond?
In parallel, the DNS has worked with the main publishers of hospital chemotherapy software to strengthen the DPD screening alerts inside prescription and dispensation tools. The audit found that alert solutions already exist across the main editors, but with varying levels of maturity. Where the target solution is not yet available, temporary parameter settings exist that meet the recommendations while more robust upgrades are delivered in the coming months.
For hospital pharmacy and oncology teams, the operational implication is twofold: verify that the installed chemotherapy software actively surfaces the DPD screening result before a fluoropyrimidine is prescribed or dispensed, and where only a temporary parameter is in place, track the vendor's roadmap to the robust release. The ANSM stresses that these digital evolutions are meant to secure the medication circuit and help establishments implement the national recommendations.
Who must act, and on what timeline?
The measures apply to every French healthcare establishment that administers fluoropyrimidine chemotherapy. There is no new consultation period: the expert opinion is published and intended for immediate application, and the November 2025 survey already confirmed that pre-therapeutic screening itself is integrated. The novelty is the harmonised dose rule and the software-alert upgrade, not the screening obligation.
| Obligation | Status before September 9, 2026 | Status now |
|---|---|---|
| Pre-therapeutic uracilemia screening before fluoropyrimidine | Mandatory | Mandatory, unchanged |
| Complete DPD deficiency | Fluoropyrimidine contraindicated | Unchanged |
| Partial DPD deficiency dose adaptation | Not harmonised between facilities | National expert opinion provides the shared framework |
| DPD screening alerts in chemotherapy software | Variable, facility-dependent | DNS coordinating vendor upgrades, temporary settings available |
What should marketing-authorisation holders do?
For the marketing-authorisation holders of 5-FU and capecitabine, the expert opinion is a signal to align educational materials, risk-management communications and pharmacovigilance follow-up with the new national dose-adaptation reference. Medical-affairs and PV teams should confirm that prescriber information reflects the harmonised partial-deficiency rule, since hospital teams will now apply a single grid rather than local practice.
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Compliance teams should now:
- Retrieve the INCa expert opinion and map your facility's current partial-deficiency dose-adaptation practice against the new national grid.
- Confirm with your chemotherapy-software vendor that DPD screening alerts are active, and obtain the timeline for the robust release if only a temporary parameter is in place.
- Brief oncology, pharmacy and pharmacovigilance teams on the harmonised rule, and update internal protocols and prescriber educational materials accordingly.
- For 5-FU and capecitabine marketing-authorisation holders, align medical-affairs and risk-management communications with the shared reference.
Obsidian's continuous, per-jurisdiction monitoring surfaces this kind of national safety update the moment the regulator publishes it, before it propagates unevenly across facilities.
