PharmacovigilanceOfficial

EMA publishes PSUSA outcome for hydroxyethyl starch: regulatory status maintained

🇪🇺 EMA · Thu 15 Oct 2026

A single assessment of periodic safety update reports for hydroxyethyl starch products ends with a 'maintenance' outcome, according to the EMA's 15 October 2026 publication.

The European Medicines Agency has published the outcome of a periodic safety update report single assessment (PSUSA) covering hydroxyethyl starch and hydroxyethyl starch combinations. The procedure is numbered PSUSA/00001694/202603, and the entry was first published on 15 October 2026.

The regulatory outcome is listed as 'maintenance'. The source page gives no further detail on the assessment, so the specific safety data reviewed and any reasoning behind the result are not stated in the published entry.

The only document attached is a list of nationally authorised medicinal products in scope of the procedure, issued as an English-language PDF of about 164 KB under reference EMADOC-1700519818-3508322. This indicates that the products concerned are authorised at national level rather than centrally.

By way of context, a PSUSA is a single assessment of related PSURs for an active substance found in medicines authorised in the EU. PSURs are pharmacovigilance reports that marketing-authorisation holders submit at defined intervals after authorisation.

What it means for your team

  • Marketing-authorisation holders for hydroxyethyl starch products should check the published list of nationally authorised products to confirm their products fall within the procedure.
  • A 'maintenance' outcome is the status given in the entry; the page itself does not describe any change to the terms of authorisation.
  • Pharmacovigilance teams should consult the full EMA documentation, as the entry gives no details of the safety findings behind the outcome.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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