Gliclazide PSUSA ends in 'maintenance' as PRAC opens tougher reviews elsewhere

What happened

On 30 October 2026 the EMA published the outcome of the periodic safety update report single assessment (PSUSA) for gliclazide. The regulatory outcome is 'maintenance': the marketing authorisations stay as they are. The agency also published a list of nationally authorised products covered by the assessment.

Three other maintenance outcomes appeared the same day: tenoxicam, nitrofurantoin (including nitrofurantoin/pyridoxine hydrochloride), and cystine/pyridoxine hydrochloride. The records do not describe the data reviewed, the questions PRAC raised, or whether any wording changes were considered. Anyone who needs that detail must read the published assessment documents.

What 'maintenance' means in practice

A PSUSA lets regulators evaluate periodic safety update reports for the same active substance together, even when products have different national authorisations. The assessment weighs the overall benefit-risk balance and can end in several ways: maintenance, variation, suspension or revocation. 'Maintenance' is the least disruptive result. The benefit-risk balance is considered unchanged, and the authorisations continue.

That does not mean the exercise was empty for MAHs. Teams should still check the published outcome and the list of nationally authorised products to confirm that each of their products is covered. They should also confirm that nothing in the outcome triggers a follow-up, such as a change to future PSUR submission arrangements. The records do not say whether any such follow-up applies to gliclazide, so this is a check to make, not an assumed result.

The contrast: PRAC's October agenda

The gliclazide result reads differently beside the PRAC meeting outcomes reported the same day. According to EMA and AIFA, the committee opened a referral on flupentixol/melitracen (Deanxit), over serious neurological and psychiatric effects. It also started a review of hypersensitivity clusters across all human normal immunoglobulin medicines, with reports linked to immunoglobulin batches.

These procedures are escalations, not routine periodic reviews. A referral is a formal EU-level evaluation of a medicine's benefit-risk balance, and it can lead to changes in how products are used. The immunoglobulin review is notable because it spans an entire product class and involves batch-linked signals, which puts manufacturing and batch traceability alongside clinical safety. Outcomes, timelines and any interim measures are not yet known from the records.

One small discrepancy for teams logging meeting dates: AIFA's page refers to a 28–30 October meeting, while the EMA highlights page address refers to 26–29 October. Check the official EMA meeting documents before citing dates in internal records.

Beyond medicines: reporting and diagnostics

Two other items matter to PV teams. First, the FDA flagged the most serious recall classification for four lots of the Werfen HemosIL AcuStar HIT-IgG(PF4-H) assay, used for heparin-induced thrombocytopenia antibodies. The FDA says the lots show negative bias that routine calibration and quality control may miss, and a supply interruption is expected. This is a device issue, not a drug safety finding. Still, a falsely negative result could affect how clinicians assess suspected HIT, which may matter for case narratives and causality assessment where laboratory confirmation is cited. The records do not report any patient harm.

Second, the Paul-Ehrlich-Institut and BfArM are backing the international #MedSafetyWeek campaign, running 2–8 November, which urges professionals and patients to report suspected side effects so risks are spotted earlier. Campaigns like this can raise spontaneous report volumes, and MAHs should be ready to receive and process them on time.

The EMA also published, dated 30 October 2026, a list of centrally authorised products with safety-related product information changes. It is a useful cross-check against your own labelling change tracking.

What to watch

The first thing to watch is the scope and timetable of the Deanxit referral and the immunoglobulin review, including any requests for data from MAHs. For gliclazide and the other maintenance outcomes, the signal is largely reassurance. The records show no new restrictions or product information changes announced with them. Finally, watch for any follow-up FDA or laboratory communication on the HIT assay lots, and for reporting trends after #MedSafetyWeek.