Canon IT Solutions Adds Pharmaceutical and Medical Device Option to 'EDI Master Cloud' - Supports Electronic Transmission of Safety Information and Adverse Event Reports with Validated Cloud Environment, Reducing CSV Operational Burden

Canon IT Solutions Inc. (Headquarters: Minato-ku, Tokyo; President and Representative Director: Hiroshi Suyama; hereinafter Canon ITS), a member of the Canon Marketing Japan Group, will begin offering a service on June 1, 2026, that supports the electronic transmission of safety information and adverse event reports in the pharmaceutical and medical device fields, as part of its inter-company electronic data exchange cloud service 'EDI-Master Cloud'.

Overview of the Electronic Transmission Service for Safety Information and Adverse Event Reports for the Pharmaceutical and Medical Device Industry

Background

In the pharmaceutical and medical device industries, electronic reporting based on Individual Case Safety Reports (ICSR*1) and various report formats has become the standard for submitting safety information and adverse event reports to domestic and international regulatory authorities. This requires reliable communication including confirmation of receipt, high-level security, and assurance of authenticity. In recent years, in addition to reporting to regulatory authorities, opportunities for B2B transmission of case information with partner companies and overseas partners have increased. This has led to growing operational burdens, including the need for Computerized System Validation (CSV) compliance and certificate management.

Canon ITS has previously provided comprehensive support for requirements related to ICSR electronic reporting and inter-company transmission, including AS2*2 communication, MDN*3 responses, and E2B*4 (R3/R2) compliance, through its packaged product 'EDI-Master B2B for Medical'. Now, the company is deploying the operational and technical expertise cultivated with this product to the cloud service 'EDI-Master Cloud', providing a platform with the operability and availability unique to the cloud.

Service Overview

This service combines the AS2 communication function of 'EDI-Master Cloud' with a regulatory reporting option for the pharmaceutical and medical device fields, enabling electronic transmission of safety information and adverse event reports, as well as inter-company data integration, on the cloud.

The regulatory reporting option provides a pre-validated cloud environment and offers change management, including system updates and electronic certificate renewals, as a service. This allows client companies to achieve stable data integration in compliance with regulatory requirements without having to build their own infrastructure or operational framework.

Features

- Rapid initiation of electronic transmission of safety information and adverse event reports in a state compliant with regulatory requirements: Provides AS2 communication and related settings necessary for adverse event reporting (E2B (R3)) and various adverse event reports, with ensured qualification (validation). - Significant reduction of CSV (Computerized System Validation) burden: Reduces the workload on the client company's side by handling infrastructure operation, security measures, and certificate updates on the cloud side. - Reliable cloud platform suitable for audits and inspections: Provides a cloud platform that meets the requirements for authenticity, integrity, and audit trails demanded during audits and inspections.

Outlook

Canon ITS will gradually expand functions to support the visualization of B2B transmission status and operational management, helping to ensure reliable data integration of safety-related information on the cloud.

Pricing

Service Name

Price (excluding tax)

Release Date

Regulatory Reporting Option

\150,000/month

June 1, 2026

*A separate contract for the 'EDI-Master Cloud Basic Service' is required.

About EDI-Master Cloud This is a cloud-native EDI service that leverages cloud-optimized technologies such as microservice architecture, auto-scaling, and container technology, providing high availability, fault tolerance, and scalability. It offers communication, conversion, job flow, and operational management functions, along with various APIs, allowing users to utilize EDI functions on the cloud without the need for servers, and also provides EDI business operation services.

https://www.canon-its.co.jp/solution/industry/cross-industry/edi/edi-mastercloud

*1 ICSR (Individual Case Safety Report): Safety report data for individual cases of adverse drug reactions/adverse events. The E2B standard is used for electronic reporting. *2 AS2 (Applicability Statement 2): A communication protocol for securely exchanging inter-company data over the Internet. Used for electronic transmission of ICSRs. *3 MDN (Message Disposition Notification): A receipt (arrival) confirmation message in AS2 communication. *4 E2B (R3/R2): International standard specification for electronic reporting of ICSRs (3rd version).

*Company and product names mentioned are registered trademarks or trademarks of their respective owners. *Information is current as of the date of announcement. Please note that details may differ from the latest information due to product discontinuation or organizational changes.