Regulatory, pharmacovigilance, quality and market-access news from EU and US regulators, HTA bodies and industry.
Germany's medicines and devices regulator has listed a manufacturer advisory on MOSAIQ, but the specific issue and required actions appear only in Elekta's attached notice.
The German regulator has listed a manufacturer field safety notice for an in-vitro diagnostic antibody product, but the public entry gives no detail on the problem or required action.
The German regulator has posted a field safety notice from TRACOE medical GmbH for its TRACOE vario device, but the listing refers readers to the manufacturer's attached Advisory Notice for details.
Germany's regulator has posted a manufacturer advisory on the eMAG in-vitro diagnostic system; the specifics of the issue sit in an attached PDF.
BfArM has published Beckman Coulter's notice covering LabPro V5.0 Maintenance Update 1 with Panel Update 09, though the issue and required actions are only in the enclosed Advisory Notice.
Germany's federal medicines and devices authority has listed an urgent field safety notice from Getinge Disinfection AB, but the details sit in the manufacturer's attached advisory document.
The German regulator has posted an urgent field safety notice from EKF-diagnostic GmbH on a reagent for Biosen analysers; the details sit in the manufacturer's attached advisory.
CMS reports that major employers support bringing electronic prior authorization to self-funded, employer-sponsored health plans, adding momentum to efforts to cut administrative burden.
An amendment to Act No. 362/2011 Coll. limits the validity of supply-interruption notifications to 60 days and requires MAHs to restate reasons and expected restocking dates when re-notifying.
The IGJ has released a report from its supervisory visit to Corcept's Dutch entity, though the source text does not disclose the findings or any required improvements.
The IGJ has released a report following a supervisory visit to Centrafarm Services B.V. in Breda, though the published description gives no findings or required measures.
Italy's medicines agency has revised the Fabhalta monitoring registry, removing a blocking eligibility field for patients with recurrent C3 glomerulopathy after kidney transplant.
The Paul-Ehrlich-Institut and BfArM have published the third 2026 issue of their joint quarterly bulletin, with features on a live vaccine reassessment and intravitreal therapy risks.
The German regulator is promoting the 2–8 November campaign, stressing that spontaneous reports of suspected adverse reactions remain central to post-authorisation safety monitoring.
The Paul-Ehrlich-Institut and BfArM say a technical error blocked online suspected adverse reaction reports from 7 to 9 October 2026, and ask affected reporters to submit again.
The Paul-Ehrlich-Institut has permitted foreign-language packs of Bavarian Nordic's chikungunya vaccine from 19 October to 15 November 2026, after the company reported a supply shortage.
The Danish Medicines Agency says Gilead Sciences Sweden AB will stop marketing Tybost (cobicistat) 150 mg tablets for commercial reasons, with the expected period starting at the end of December 2026.
The Danish Medicines Agency expects UCB Nordic's lacosamide 100 mg film-coated tablets to be affected from early November 2026 until early February 2027, citing increased sales and demand.
The Danish Medicines Agency says Thea Nordic AB's latanoprost/timolol eye drops are affected by production problems, with disruption expected from late September to early December 2026.
The Danish Medicines Agency says Euthasol vet. 400 mg/ml is affected by production problems, with disruption expected from late September to early November 2026.
A decision dated 27 October 2026 amends the 'médication officinale' list, adding an arnica gel and two homeopathic granule products to Annex III.
The French medicines agency published the decision on 28 October; the notice does not say which generic groups or products are affected.
A Commission decision adopted on 26 October 2026 adds Singapore to the list of recognised third countries for importing active substances, once the implementing decision enters into force.
At its senior-level meeting in Brussels on 27 and 28 October, the committee also followed up on its recent opinion on extreme heat and heatwaves.
DG SANTE has released a Health Security Committee opinion on mosquito-borne diseases, though the available information does not set out its content, scope or any obligations.
The agency's weekly list for 19 to 23 October 2026 covers notices from 14 manufacturers, among them glucose monitoring, infusion pump, defibrillator and X-ray equipment.
Implementing Regulation (EU) 2026/2300 authorises the 'Active chlorine based products BPF' family held by CID LINES NV under the Biocidal Products Regulation.
The EU regulator has issued a notice on the validation and qualification of computerised systems used in clinical trials; the details are not set out in the information available.
The agency's draft guidance sets out how an individualized genome editing product with several variants can be covered by one Biologics License Application, including after licensure.
The Dutch inspectorate IGJ has published a manufacturer warning on the LUISA, TIVAN, LS and Life One ventilator range, citing a possible communication failure of the battery.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.