Regulatory Challenges in Multilingual Pharmaceutical Labelling for Global Drug Distribution
Year: 2026
Type: article
Abstract: Background: Medicines are distributed across jurisdictions that impose different requirements on the language, content, format and presentation of labels and package leaflets. Multilingual labelling affects regulatory compliance, translation quality, patient safety, packaging design and lifecycle management, but the relevant evidence is dispersed across separate fields. Methods: Narrative review of official regulatory documents from ten jurisdictions or regions (USA, EU, India, Japan, China, GCC, ASEAN, Canada, Australia, Brazil), international standards, and scholarly literature, mainly 2000–2026, with emphasis on developments in 2023–2026. Findings: Language obligations depend on market, product category and pack component; templates and formats differ by regulator; regional arrangements do not remove national requirements. Evidence shows that literacy and language barriers impair understanding of medicine information, but direct studies of multilingual labels are few and exploratory. Translation quality can be governed through process standards and error metrics, while machine translation and AI performance varies by language and requires human oversight. Multilingual packs create space pressure that affects legibility, and readability measures are language-specific. Electronic labelling is advancing quickly but unevenly, with equity safeguards a central concern. Lifecycle control is needed to keep all language versions consistent with approved text. Conclusions: An integrated framework built on regulatory compliance, information equivalence and operational control is proposed, with five pillars and an unvalidated review checklist. Priorities for research include audits of authentic labels, user testing, evaluation of AI-assisted translation and validation of the framework.
Language: English
Subfield: Pharmacy
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7225823462
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