Therapeutic innovation & regulatory science · 2026
Regulatory Approaches to Electronic Labelling in the USA, EU, and India: A Comparative Overview.
СтатьяОбзорСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Saini Komal, Singh Ramandeep
Аннотация
OBJECTIVE: In this era of growth, e-labelling is becoming increasingly important as the labels are important sources of information for patients. However, regulations governing e-labeling for pharmaceuticals and medical equipment varies throughout the countries. This review compares the e-labelling regulation approaches in EU, USA, and India.
SCOPE: The regulations have been initiated by appropriate governments and/or health authorities of EU, USA, and India in collaboration with key stakeholders, including patients, healthcare providers, pharmaceutical companies, environmental and regulatory agencies. EU and USA have established the digital labelling but India still relies on paper instruction manuals with limited digital systems.
METHODOLOGY: The regulatory information and current trends of e-labelling in EU, US, and India were studied and compared for electronic prescribing and electronic decision support systems with health record. Regulatory information was recognized through a structured review of official regulatory agency websites (FDA, EMA, CDSCO), international organizations (WHO, ICH), and peer-reviewed literature accessed through databases such as PubMed and Google Scholar. Eligible sources comprised official regulations, guidance documents, policy reports, and peer-reviewed articles specifically addressing pharmaceutical e-labelling, while draft policies and unrelated documents were excluded. Data were synthesized using qualitative thematic analysis, and cross-jurisdictional comparisons were structured across predefined domains including regulatory scope, legal status, implementation stage, digital infrastructure, and stakeholder accessibility.
KEY FINDINGS: Common challenges include maintaining authenticity, readability, and interoperability of e-labels. Technologies like QR codes, barcoding, and decision support tools increase safety and access. However, digital implementation and regulatory maturity differ generally between the developed and developing nations.
SCOPE: The regulations have been initiated by appropriate governments and/or health authorities of EU, USA, and India in collaboration with key stakeholders, including patients, healthcare providers, pharmaceutical companies, environmental and regulatory agencies. EU and USA have established the digital labelling but India still relies on paper instruction manuals with limited digital systems.
METHODOLOGY: The regulatory information and current trends of e-labelling in EU, US, and India were studied and compared for electronic prescribing and electronic decision support systems with health record. Regulatory information was recognized through a structured review of official regulatory agency websites (FDA, EMA, CDSCO), international organizations (WHO, ICH), and peer-reviewed literature accessed through databases such as PubMed and Google Scholar. Eligible sources comprised official regulations, guidance documents, policy reports, and peer-reviewed articles specifically addressing pharmaceutical e-labelling, while draft policies and unrelated documents were excluded. Data were synthesized using qualitative thematic analysis, and cross-jurisdictional comparisons were structured across predefined domains including regulatory scope, legal status, implementation stage, digital infrastructure, and stakeholder accessibility.
KEY FINDINGS: Common challenges include maintaining authenticity, readability, and interoperability of e-labels. Technologies like QR codes, barcoding, and decision support tools increase safety and access. However, digital implementation and regulatory maturity differ generally between the developed and developing nations.