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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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Real-time algorithmic exchange and processing of pharmaceutical quality data and information.

Craig Anderson1, Marquerita Algorri2, Michael J Abernathy2

  • 1Department of Global Regulatory Science - International Labeling Group, Pfizer Inc., Kirkland, Quebec H9J 2M5, Canada.

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A new method uses Health Level 7 International

Keywords:
APIChemistryFHIRManufacturing and controls (CMC)Medicinal productsPharmaceutical qualityPharmaceutical regulatory affairs

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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.