Pharmaceuticals and Medical Devices Agency's (PMDA)

Revolutionizing Pharmaceutical Information: Japan's Electronic Package Insert System

Global Regulations

Labelling

Products are required to display information in writing.

Japan's Electronic Package Insert System

Japan has pioneered a transformative approach to pharmaceutical tracking and traceability through its mandatory Electronic Package Insert (EPI) system. Since August 2021, the Japanese regulatory framework has fundamentally shifted from traditional paper-based documentation to a comprehensive digital ecosystem that ensures real-time access to critical product information while maintaining robust traceability throughout the pharmaceutical supply chain.

Regulatory Compliance Notice

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Key Features of Japan's Electronic Package Insert Regulations

Digital-First Documentation Framework

The Japanese system mandates that Marketing Authorization Holders (MAHs) eliminate paper package inserts for most pharmaceutical products, medical devices, and in vitro diagnostics. Instead, all product information must be made available electronically through designated websites and the PMDA's Safety Information Posting System. This digital transformation ensures that healthcare professionals and patients always have access to the most current safety and usage information, while creating a comprehensive digital trail for regulatory oversight.

Integrated Barcode and QR Code Technology

Every pharmaceutical product's outer packaging must display a barcode or two-dimensional code that serves as a direct gateway to electronic documentation. When scanned using smartphones or the official PI-navi application, these codes instantly connect users to the product's complete regulatory profile, including package inserts, drug guides, Risk Management Plans, revision histories, and safety alerts. This seamless integration between physical products and digital information creates an unbreakable chain of traceability.

Comprehensive Safety Information Repository

The regulatory framework requires MAHs to maintain extensive digital repositories containing not only basic package inserts but also patient guides, healthcare professional resources, adverse drug reaction manuals, Dear Healthcare Professional Letters, and complete revision histories. This comprehensive approach ensures that all stakeholders have immediate access to critical safety information while maintaining a complete audit trail of all product-related communications and updates.

Real-Time Regulatory Compliance Monitoring

Japan's system enables continuous monitoring of pharmaceutical products through mandatory registration on the PMDA's Safety Information Posting System. The framework supports real-time updates to product information, immediate distribution of safety alerts, and comprehensive tracking of regulatory changes. This dynamic approach ensures that compliance monitoring occurs in real-time rather than through periodic audits, significantly enhancing patient safety and regulatory oversight.

Why Choose Our iTS Compliance Solution

Expert Guidance

Our team of compliance experts possesses in-depth knowledge of iTS and Turkish pharmaceutical regulations. From serialization strategies to data reporting, we guide your organization through the intricacies of compliance, ensuring a smooth and informed journey.

Cutting-Edge Technology

Leverage our state-of-the-art compliance solution, designed to integrate seamlessly with iTS requirements. Our technology ensures accuracy, efficiency, and real-time visibility, empowering your organization to meet and exceed compliance expectations.

Future-Ready Operations

Compliance is not just about meeting today's standards; it's about preparing for the future. Our solution is designed to evolve with regulatory changes, ensuring that your organization remains at the forefront of compliance in the dynamic Turkish pharmaceutical landscape.

Transparent Collaboration

We believe in transparent collaboration. Partner with us, and we'll work closely with your team to implement and maintain compliance measures. Our goal is to build a resilient, compliant, and future-ready pharmaceutical supply chain together.

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How LSPedia Can Facilitate Japan EPI Compliance

LSPedia's comprehensive software platform provides pharmaceutical companies with end-to-end solutions for implementing Japan's Electronic Package Insert requirements. Our system seamlessly integrates with existing manufacturing and distribution processes to automate the generation of compliant barcodes and QR codes, manage electronic documentation workflows, and ensure real-time synchronization with the PMDA's Safety Information Posting System. We handle the complex technical integration between physical packaging and digital repositories, enabling companies to achieve full compliance while minimizing operational disruption and ensuring seamless transition from traditional paper-based systems to Japan's innovative digital framework.

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