Solution Overview: Cloudbyz AI-Powered Foreign Action Notification (FAN) Compliance Platform

To support sponsors in meeting Health Canada’s regulatory requirement for Foreign Action Notifications (FAN) in a timely, consistent, and compliant manner, Cloudbyz has developed an AI-powered solution built on AWS infrastructure. This platform leverages natural language processing (NLP) and machine learning to automate monitoring, extraction, classification, and reporting of foreign regulatory actions from global health authority sources such as the FDA, EMA, PMDA, TGA, and MHRA.

Key Features of the Cloudbyz FAN Solution:

• Automated Surveillance: AI agents continuously monitor designated global regulatory sites and structured/unstructured data sources for new foreign decisions (e.g., suspensions, withdrawals, recalls, rejections).

• Intelligent Extraction: NLP models extract relevant information such as product names, regulatory authority, decision date, and nature of the action.

• Smart Classification: The AI classifies actions based on their relevance to Canadian-authorized products and FAN criteria.

• Notification Workflow: Configurable rules trigger internal workflows for regulatory affairs teams to review and submit FANs within the 72-hour window mandated by Health Canada.

• Audit & Traceability: Full logging, source documentation archiving, and export-ready FAN templates aligned with Health Canada’s requirements.

• Scalable AWS Architecture: Hosted on Amazon Web Services (AWS), the platform ensures high availability, secure data processing, and scalability.

Case Study: Accelerating Health Canada FAN Compliance with Cloudbyz AI on AWS

Background

A global mid-sized biopharmaceutical company faced significant operational challenges in tracking and complying with Health Canada’s FAN regulation. Manual monitoring of foreign regulatory sites was inconsistent, slow, and error-prone, leading to compliance risks and resource inefficiencies.

Challenge

• Lack of automated monitoring of foreign regulatory actions

• Delays in detecting relevant regulatory decisions affecting Canadian drugs

• Difficulty in mapping foreign actions to Canadian-approved products

• Time-consuming and inconsistent preparation of FAN submissions within 72-hour deadlines

Solution Implementation

The company partnered with Cloudbyz to implement an AI-powered FAN monitoring and notification system. Leveraging AWS services such as Amazon Comprehend, AWS Lambda, Amazon S3, and Amazon SageMaker, Cloudbyz delivered a configurable, cloud-native solution within 10 weeks.

Core Capabilities Delivered:

• Data Ingestion: Using custom crawlers and APIs to pull structured and unstructured data from over 25 global health authority websites.

• AI-Powered Analysis: NLP algorithms detect foreign actions (suspensions, withdrawals, etc.), and match drug identifiers (INN, brand names, DINs) to Canadian marketed products.

• Risk Scoring Engine: AI assigns priority based on action type, therapeutic class, and market impact.

• Regulatory Workflow Integration: Automated ticket creation, alerting, and routing within the regulatory affairs team using Salesforce-based Cloudbyz workflows.

• Submission Ready Output: Pre-populated FAN templates aligned with Health Canada’s FAN guidance.

Results and Impact

• 90% reduction in manual effort required to monitor and process foreign actions

• Automated detection within 1 hour of a foreign action appearing online

• 100% compliance rate with 72-hour FAN submission deadlines since implementation

• Improved traceability and audit readiness with automated logs and source capture

• Scalable AI system ready to be extended to other regulatory markets and processes

Quantified Benefits:

Lessons Learned

• A proactive AI-driven compliance framework significantly reduces regulatory risk.

• Integration with enterprise systems (e.g., Cloudbyz eClinical & PV, Salesforce, Veeva) ensures a closed-loop process.

• Configurability of rules and alert thresholds is essential to minimize false positives and streamline team workflows.

• The scalability of AWS infrastructure enabled rapid deployment and reliable global monitoring.