Biopharmaceutical industry internal/external Chemistry, Manufacturing and Controls (CMC) data exchange CMC accounts for over 70% of all internal and external interactions, internationally, within the company; and between the company and its stakeholders. Despite much of the content being sourced from internal systems that support structured data (e.g., pharmaceutical development systems, manufacturing site systems), and much of it being available for reuse across many medicinal products, all CMC content is authored and managed by industry in unstructured Word or PDF. This is not sustainable given the increasing volume and frequency of work. Not only are these processes unsustainable, but they are highly manual and error-prone having the potential to impact global drug supply. CMC content can be reused throughout the medicinal product lifecycle. For example, accurate identification when tracking product complaints; tracing AEs back to the site of manufacture; reusing the medicinal products composition in labelling. Other key areas of the medicinal product lifecycle are transitioning to FHIR and are already in the HL7 working group portfolio. E.g., Adverse Event reporting; Real World Data (RWD); electronic Product Information (ePI); and Pharmaceutical Quality (PQ). Therefore, there is great value in ensuring industry’s CMC data exchange is also transitioned to FHIR. FDA’s Pharmaceutical Quality project initiated this structuring of CMC data and representing it in FHIR. The current BR&R Pharmaceutical Quality project is supporting the CMC domain but specific to CMC data exchange between the biopharmaceutical industry and the FDA. This project fits into the overall strategic goal to achieve a total transition to structured electronic data. This transition will facilitate innovation and accelerate the global exchange of CMC data and will look to leverage the parts of CMC that are already represented in FHIR by FDA’s PQ-CMC Project.

• Members of the biopharmaceutical industry are implementing structured authoring solutions internally. Software developers working with industry on structured authoring projects are looking for guidance on common standards. In the absence of an international standard, the industry is likely to develop divergent solutions and approaches to facilitate data exchange internally, with other biopharma companies or with third parties. • Other key topic domains, all of which are inter-related with the medicinal product lifecycle, are transitioning to a structured approach (e.g., medicinal product information/labelling, Adverse Event reporting, clinical trial applications). Industry needs to exchange data between internal departments as much as with external parties. Industry’s enterprise architectures and systems (e.g., structured authoring, master data management, data lakes, regulatory information management, API interfaces, operations management) benefit from having standardized data models and means of exchange. • Industry is transitioning internal architectures and systems to a more cloud friendly business model. The continued structuring of CMC data and representation in FHIR will allow industry to benefit from the use of web 2.0 technology and framework.