Data Dictionary

Last updated: 2026-03-27

Overview

This Data Dictionary defines the fields and terms used in the ALIGN Global Hub. It provides clarity on the source, definition, and possible values for each metric displayed in the dashboard.

Key Terminology

Global Regulatory Approval (GRA)

The Global Regulatory Approval field indicates whether a health product has received authorization or prequalification by a global body.

  • Includes: WHO Prequalification (PQ), US FDA approval, EMA approval, or other approvals from Stringent Regulatory Authorities (SRA).
  • Emergency Use: Includes Emergency Use Authorizations (EUA) where applicable for public health emergencies.
  • Values: Yes, No, Under Review.

Trial Phase

The development stage of the product based on clinical trial activity.

  • Rule: If a product is in multiple phases simultaneously (e.g., Phase 2/3), the highest phase is recorded.

  • Values:

    • Phase 1: Initial human safety testing.
    • Phase 2: Efficacy and safety testing in target populations.
    • Phase 3: Large-scale confirmatory testing.
    • Phase 4: Post-marketing surveillance.
    • Approved / Marketed: Formally approved for use.

National Regulatory Authority (NRA)

Indicates the status of national marketing authorization in specific countries (e.g., Kenya, Senegal, South Africa).

  • Values: Yes, No, Under Review.

WHO Essential Medicines List (EML)

Indicates if the product is listed on the WHO Model List of Essential Medicines or the Model List of Essential Diagnostics.

  • Values: Yes, No.

Field Definitions

Field Name Description Source
innovation The primary name of the product or innovation. Aggregated
manufacturer The primary manufacturer or lead developer of the product. Aggregated
disease The target disease area (HIV, TB, Malaria, MNCH). Aggregated
category The type of product (Diagnostic, Therapeutic, Vaccine, etc.). Aggregated
trial_status The current clinical development stage. Aggregated
proj_date_first_launch The projected or observed date of first country-level launch. Mao et al. (2025) Method
proj_date_lmic_20_uptake The projected date for 20% market uptake in LMICs. Mao et al. (2025) Method
people_at_risk Estimated number of individuals at risk for the disease. Population Data (GBD/WHO)
dalys Disability-Adjusted Life Years attributable to the disease. IHME / GBD
readiness A composite score (0-100) indicating introduction readiness. ALIGN Assessment

Methodology References

For detailed information on how projected dates and readiness scores are calculated, please refer to the following documents:

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