{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T07:01:15Z","timestamp":1780383675820,"version":"3.54.1"},"reference-count":58,"publisher":"MDPI AG","issue":"2","license":[{"start":{"date-parts":[[2026,2,21]],"date-time":"2026-02-21T00:00:00Z","timestamp":1771632000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Antibiotics"],"abstract":"<jats:p>Background: Antimicrobial resistance (AMR) poses a critical global public health challenge requiring comprehensive intervention strategies, including robust antibiotic stewardship programs. The European Commission\u2019s 2017 One Health Action Plan against AMR established guidelines based on WHO\u2019s AWaRe classification system, which categorizes antibiotics into Access, Watch, and Reserve groups to promote prudent use. However, the proliferation of substandard and falsified (SF) medical products increasingly undermines these stewardship efforts, with European regulatory agencies, including Belgium\u2019s Federal Agency for Medicines and Health Products (FAMHP), reporting rising seizures of SF antibiotics. Objective: To assess the pharmaceutical quality of confiscated antibiotic samples and evaluate their potential contribution to AMR development. Methods: We conducted comprehensive pharmaceutical quality control testing on 40 SF antibiotic samples seized by the FAMHP between early 2024 and late 2025. Results: The analysis revealed significant deficiencies: 35% of samples contained antibiotics listed on international watch lists, while nearly 43% failed quality control testing. Dissolution defects represented the predominant failure mode, accounting for 29% of all samples tested. These defects can severely compromise drug bioavailability, clinical efficiency, and expose bacterial populations to sub-lethal concentrations of active pharmaceutical ingredients\u2014a recognized driver of resistance development. Conclusions: Many seized samples appeared to be unregistered\/unlicensed medicines that, while prohibited in the EU, may circulate legally elsewhere. This transnational dimension highlights how substandard products threaten global AMR control initiatives beyond individual patient safety. These findings underscore the urgent need to raise more awareness within the EU and for enhanced pharmaceutical quality assurance systems and much more international regulatory cooperation, particularly in low- and middle-income countries where such products circulate more readily.<\/jats:p>","DOI":"10.3390\/antibiotics15020230","type":"journal-article","created":{"date-parts":[[2026,2,23]],"date-time":"2026-02-23T10:00:52Z","timestamp":1771840852000},"page":"230","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Substandard and Falsified Antibiotics Seized in Belgium: Quality Control Analysis Reveals High Prevalence of WHO Watch List Molecules and Bioavailability Non-Compliance"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6634-3706","authenticated-orcid":false,"given":"Celine","family":"Vanhee","sequence":"first","affiliation":[{"name":"Service Medicines and Health Products, Scientific Direction of Chemical and Physical Health Risks, Sciensano, J. Wytsmanstraat 14, 1050 Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-0465-4569","authenticated-orcid":false,"given":"Clo\u00eb","family":"Degr\u00e8ve","sequence":"additional","affiliation":[{"name":"Service Medicines and Health Products, Scientific Direction of Chemical and Physical Health Risks, Sciensano, J. Wytsmanstraat 14, 1050 Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Canfyn","sequence":"additional","affiliation":[{"name":"Service Medicines and Health Products, Scientific Direction of Chemical and Physical Health Risks, Sciensano, J. Wytsmanstraat 14, 1050 Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niels","family":"Boschmans","sequence":"additional","affiliation":[{"name":"Service Medicines and Health Products, Scientific Direction of Chemical and Physical Health Risks, Sciensano, J. Wytsmanstraat 14, 1050 Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7307-9619","authenticated-orcid":false,"given":"Bram","family":"Jacobs","sequence":"additional","affiliation":[{"name":"Service of Foodborne Pathogens, Scientific Direction of Infectious Diseases in Humans, Sciensano, J. Wytsmanstraat 14, 1050 Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koenraad","family":"Van Hoorde","sequence":"additional","affiliation":[{"name":"Service of Foodborne Pathogens, Scientific Direction of Infectious Diseases in Humans, Sciensano, J. Wytsmanstraat 14, 1050 Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6980-6684","authenticated-orcid":false,"given":"Eric","family":"Deconinck","sequence":"additional","affiliation":[{"name":"Service Medicines and Health Products, Scientific Direction of Chemical and Physical Health Risks, Sciensano, J. Wytsmanstraat 14, 1050 Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4739-7511","authenticated-orcid":false,"given":"Marie","family":"Willocx","sequence":"additional","affiliation":[{"name":"Service Medicines and Health Products, Scientific Direction of Chemical and Physical Health Risks, Sciensano, J. Wytsmanstraat 14, 1050 Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans Van der","family":"Meersch","sequence":"additional","affiliation":[{"name":"Federal Agency for Medicine and Health Products, Galileelaan 5\/03, 1210 Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bart","family":"Ceyssens","sequence":"additional","affiliation":[{"name":"Federal Agency for Medicine and Health Products, Galileelaan 5\/03, 1210 Brussels, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,2,21]]},"reference":[{"key":"ref_1","unstructured":"GBD 2021 Antimicrobial Resistance Collaborators (2024). Global burden of bacterial antimicrobial resistance 1990\u20132021: A systematic analysis with forecasts to 2050. 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