Real-time algorithmic exchange and processing of pharmaceutical quality data and information

Area of Science:

• Biopharmaceutical industry
• Health informatics
• Regulatory science

Background:

• Current pharmaceutical regulatory workflows take months to years.
• Health Level 7 International's (HL7) Fast Healthcare Interoperability Resources (FHIR) standard is used for electronic health record exchange.
• Adaptation of FHIR for regulatory use cases, including Electronic Product Information (ePI), chemistry, manufacturing, and controls (CMC) data, and adverse event reporting, is ongoing.

Purpose of the Study:

• To propose a modern method for real-time medicinal product information exchange.
• To leverage FHIR standard, APIs, digitization, and AI for pharmaceutical regulatory data.
• To examine real-world implementation examples of FHIR for CMC information exchange.

Main Methods:

• Utilizing the HL7 FHIR standard and APIs for data exchange.
• Implementing digitization and artificial intelligence for processing information.
• Focusing on the exchange of CMC data within the biopharmaceutical industry.

Main Results:

• Expected improvements in efficiency, reduced time and effort for regulatory information management.
• Acceleration of decision-making processes.
• Potential reduction of data exchange timelines from months to days or hours.

Conclusions:

• The proposed FHIR-based method can significantly enhance efficiency and speed in pharmaceutical regulatory workflows.
• This approach is expected to foster innovation and improve agility in information exchange.
• The biopharmaceutical industry can reach more patients faster through improved digitization, automation, and interoperability.