Regulatory Workflows and Interactions - pharma, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/APIX---API-Exchange-for-Medicinal-Products/ and changes regularly. See the Directory of published versions

Workflow

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The Four Phases

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Workflow Diagram

The following diagram shows the complete lifecycle of a regulatory procedure through RWI-pharma — illustrating the back-and-forth exchange between Company and Regulator across all four phases.

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Key Concepts

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Step-by-Step Walkthrough: Shelf-Life Update

The detailed exchange for a shelf-life update, with links to the example Task resources at each step. Jump straight to a key example:

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Sequence Diagram

sequenceDiagram
    participant C as Company
    participant R as Regulator
    
    %% Phase 0: Registration
    Note over C,R: Phase 0: Registration & Connection
    C->>R: 0.1 Register with Regulator Portal
    R-->>C: Client Credentials & Org ID
    C->>R: 0.2 OAuth2 Authentication
    
    %% Phase 1: Submission
    Note over C,R: Phase 1: Submission & Validation
    par Upload Binaries/Bundles
        C->>R: 1.1 POST PDFs (Binary)
        C->>R: 1.1 POST Labels (Document Bundles)
        C->>R: 1.1 POST CMC (Transaction Bundles)
    end
    C->>R: 1.2 POST DocumentReferences (IDs/Links)
    C->>R: 1.3 POST Task (Orchestrator Index)
    
    activate R
    R->>R: 2.0 Validate Application
    
    alt Validation Passes
        R-->>C: 3.1 Ack Receipt & Validation Results
    else Validation Fails
        R->>C: 4.1 Request Missing Documents
        C->>R: 4.2.1 Submit Missing Documents
        R->>R: 4.2.2 Re-validate
    end
    
    %% Phase 2: Review
    Note over C,R: Phase 2: Review Cycles
    
    par Parallel Checks
        rect rgb(240, 248, 255)
            Note right of R: Technical Review
            R->>R: 5.2.1 Check Compliance
        end
        
        rect rgb(255, 250, 240)
            Note right of R: Financial Review
            R->>R: Review Financials
            Note over R: 5.B.2 Invoice Sequence
            R->>R: POST Invoice (Binary/Resource)
            R->>R: POST DocumentReference
            R->>C: POST Payment Task (Input: DocRef)
            activate C
            Note over C: 5.B.3 Payment Sequence
            C->>C: POST Proof of Payment (Binary)
            C->>C: POST DocumentReference
            C-->>R: Update Task (Add Output DocRef)
            deactivate C
            R->>R: 5.B.4 Verify Proof & Set Task: completed
        end
    end
    
    loop Issue Resolution
        alt Issue Found
            Note over R: 5.3.1 Question Sequence
            R->>R: POST Questionnaire
            R->>R: POST DocumentReference
            R->>C: POST Question Task (Input: DocRef)
            activate C
            Note over C: 5.3.2 Response Sequence
            C->>C: POST QuestionnaireResponse
            C->>C: POST DocumentReference
            C-->>R: Update Task (Add Output DocRef)
            deactivate C
            R->>R: 5.3.3 Review & Set Task: completed
        else No Issues
            R->>R: Proceed to Decision
        end
    end
    
    %% Phase 3: Decision
    Note over C,R: Phase 3: Final Decision
    
    alt Approved
        R-->>C: 6.1 Notify Approval (Decision Letter)
    else Rejected
        R-->>C: 7.1 Notify Rejection
    end
    deactivate R