The role of pharmaceutical regulation and policy in combatting antimicrobial resistance (AMR)
Publication date
2026-04-08
Authors
Opalska, Aleksandra Beata
Editors
Advisors
Supervisors
Leufkens, Hubert G.
Kwa, Marcel
Document Type
Dissertation
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Abstract
This thesis places one of the most serious public health threats facing the world today — antimicrobial resistance (AMR) — at centre stage. It examines the intersection between the AMR crisis and pharmaceutical regulation and policy, exploring the extent to which selected regulatory and policy mechanisms can contribute to addressing this pressing challenge. Through a series of case studies, the thesis analyses key factors relevant to tackling AMR, including the appropriate use of antimicrobials, incentives to stimulate the development of new antimicrobial agents, and other regulatory and policy tools available to support a more effective response.
Keywords
antimicrobiële resistentie, oude en nieuwe antibiotica, passend en rationeel gebruik van antibiotica, de huidige en nieuwe EU-farmaceutische wetgeving, Europees Geneesmiddelenbureau, stimulansen, Europese regelgevende maatregelen (bijv. verwijzingsprocedures) en instrumenten (bijv. wetenschappelijk advies), COVID-19, productinformatie van geneesmiddelen, antimicrobial resistance, old and new antibiotics, appropriate and rational use of antibiotics, the current and new EU Pharmaceutical Legislation, European Medicines Agency, incentives, European regulatory measures (e.g. referral procedures) and tools (e.g. Scientific Advice), COVID-19, medicine product information, SDG 3 - Good Health and Well-being
Citation
Opalska, A B 2026, 'The role of pharmaceutical regulation and policy in combatting antimicrobial resistance (AMR)', Doctor of Philosophy, Universiteit Utrecht. https://doi.org/10.33540/3438