JMIR Publications

ABSTRACT

Background:

Accurate and up-to-date medicinal product information is essential for the safe and effective use of medicines. Electronic labeling (e-labeling) has emerged as a potential alternative to paper-based package inserts by enabling timely updates, improving accessibility, and supporting integration with digital health systems. However, regulatory approaches to pharmaceutical e-labeling remain fragmented across jurisdictions.

Objective:

This study examined how e-labeling policies have developed across International Coalition of Medicines Regulatory Authorities (ICMRA) member jurisdictions and explored the conditions associated with policies that position e-labeling as a replacement for paper-based product information.

Methods:

We conducted a cross-sectional comparative policy analysis of publicly available national regulatory documents on pharmaceutical e-labeling issued between 1 January 2012 and 31 May 2026. The analysis focused on how regulatory intent, legal authority, implementation mechanisms, and replacement pathways were articulated in official policy documents across jurisdictions. A main corpus of official jurisdictional policy documents was supplemented by a triangulation corpus of international stakeholder documents. Hybrid thematic analysis and content analysis were used to identify and compare policy themes across jurisdictions. A four-level e-labeling regulatory maturity framework was developed using three indicators: implementation status, level of authority, and expansion toward advanced considerations. Fuzzy-set qualitative comparative analysis (fsQCA) was then conducted across 19 jurisdictions to identify configurational patterns associated with paper-label replacement.

Results:

Eighty-one policy documents from 20 jurisdictions were included in the main analysis, and 27 documents were included in the triangulation corpus. Nine themes were identified across three domains: e-labeling scope and implementation strategy, operational infrastructure, and advanced considerations. Most policies addressed target product information, medicine categories, transition approaches, interface mechanisms, and responsible entities. In contrast, structured digital formats, interoperability, and personalized information were less consistently addressed. The maturity assessment showed substantial variation across jurisdictions. Brazil and the Netherlands were classified at the highest maturity level, reflecting implementation with a legal basis and expansion toward advanced functions. The fsQCA identified one conservative sufficient configuration associated with paper-label replacement: digital infrastructure readiness, high e-labeling policy maturity, and explicit responsibility of the marketing authorization holder.

Conclusions:

Pharmaceutical e-labeling has moved beyond early policy discussion in many ICMRA member jurisdictions, but regulatory maturity remains uneven. While most jurisdictions enable electronic access to product information, relatively few have established the legal and operational foundations to replace paper labeling. Paper-label replacement was associated with mature regulatory frameworks and clear operational responsibility. By combining a cross-jurisdictional regulatory maturity framework with fsQCA, this study provides a novel comparative approach that extends beyond previous descriptive studies by identifying the conditions associated with paper-label replacement. The proposed framework may offer a structured approach to assessing regulatory readiness and prioritizing the efforts required for effective legal development and implementation.