1c. Is Your Project an Investigative Project (aka PSS-Lite)?
1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU?
1e. Today's Date
1f. Name of standard being reaffirmed
1g. Project Artifact Information
1h. ISO/IEC Standard to Adopt
1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption?
1j. Unit of Measure
2a. Primary/Sponsor WG
Biomedical Research & Regulation
2d. Project Facilitator
Mary Ann Slack; Boris Brodsky
2e. Other Interested Parties (and roles)
European Medicines Agency (EMA)
2f. Modeling Facilitator
2g. Publishing Facilitator
2h. Vocabulary Facilitator
2i. Domain Expert Representative
FDA Reviewers: Norman Schmuff, Norman Gregory, Frank Holcombe, Michael Kerrigan
2j. Business Requirements Analyst
Smita Hastak, Catherine-Hosage Norman
2k. Conformance Facilitator
2l. Other Facilitators
US FDA, 5 Pharmaceutical companies implementing a proof-of-concept.
3a. Project Scope
The scope of this effort covers the domain of Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC), e.g., Specification, Stability, Method Validation, Batch, Batch Analysis result, etc. The objective is to develop HL7 FHIR data exchange standard for the PQ/CMC domain that covers Pharmaceutical Quality in Module 3(Quality Section) of eCTD submissions to the US FDA. Currently the baseline requirements are specific to the US, but this may expand to be global.
3b. Project Need
To support the FDA’s regulatory needs in receiving structured and standardized data in pharmaceutical quality as described in the FDA Strategic Priorities 2014-2018.
3c. Security Risk
3d. External Drivers
3e. Objectives/Deliverables and Target Dates
Two objectives: 1. To standardize the pharamaceutical quality data that is currently received by the FDA in eCTD Module 3 from the sponsoring organizations. 2. To use these structured elements and develop a FHIR Data exchange solution.
Deliverable: FHIR Profiles and IG in support of Pharmaceutical Quality data submission.
FHIR IG with Quality Specification Profile--January 2020 Ballot
3f. Common Names / Keywords / Aliases:
Pharmaceutical Quality, Drug Quality, CMC, Product Quality
3h. Project Dependencies
Some FHIR Resources that are needed for PQ/CMC are owned by other HL7 WG, such as PlanDefinition, Observation, Specimen, etc.
Dependency on some BR&R IDMP Resources too. Working closely with IDMP resource developers and providing input and PQ requirements. Adding tacker items for requirements to resources from other WGs.
4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?
4c. FHIR Profiles Version
4d. Please define your New Product Definition
4d. Please define your New Product Family
5a. Project Intent
Create new standard, Implementation Guide (IG) will be created/modified
5a. White Paper Type
5a. Is the project adopting/endorsing an externally developed IG?
5a. Externally developed IG is to be (select one)
5a. Specify external organization
5a. Revising Current Standard Info
5b. Project Ballot Type
STU to Normative
5c. Additional Ballot Info
Plan to do a phased approach for balloting. The entire PQ/CMC domain will most likely support multiple profiles. Plan is to ballot the first profile with PQ/CMC FHIR IG and then include additional profiles and build on the existing PQ/CMC IG in subsequent ballots..
5d. Joint Copyright
5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.
6a. External Project Collaboration
6b. Content Already Developed
90% of the domain content was developed by FDA with substantial feedback from the Pharamaceutical industry.; 30% FHIR resources mapping identified. Work-in-progress to identify gaps in existing resources. Coordinating with BR&R and other WGs.
6c. Content externally developed?
6d. List Developers of Externally Developed Content
6e. Is this a hosted (externally funded) project?
Regulatory Agency, Standards Development Organizations (SDOs), Other
6f. Other Stakeholders
Pharmaceutical Industry, Testing Facilities/ CRO, Drug Manufacturing entities