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Medicines regulatory approval

Caribbean Member States rely on regional collaboration to efficiently assess and approve medicines, vaccines, and other health products. Within CARPHA, the Caribbean Regulatory System (CRS) reviews products and makes recommendations to CARICOM Member States for market authorization or import approval. These assessments are often based on reliance on trusted sources such as the World Health Organization (WHO) prequalification programme or recognised regulatory authorities, allowing countries to benefit from existing evaluations while maintaining regional oversight.

Once a product is recommended, the decision and associated product information—such as manufacturer, formulation, and approval status—are recorded in the CRS Registry, which acts as a regional product catalogue. National authorities use this information to support local regulatory decisions, procurement, and policy-making.

This use case illustrates how a cross-border healthcare architecture can support regulatory alignment by enabling shared access to product information and recommendations, reducing duplication of effort, and strengthening trust across countries.

Challenge today

  • Duplication of regulatory efforts across countries
  • Limited visibility of product approvals across the region
  • Inconsistent product identification and naming
  • Delays in accessing regulatory decisions
  • Fragmented systems for managing product information

Desired situation

  • A shared and trusted product catalogue (CRS Registry) with regulatory recommendations
  • Transparent and accessible product approval information across countries
  • Consistent identification of medicines and manufacturers
  • Faster regulatory decision-making through reliance mechanisms
  • Alignment between regulatory authorities and procurement bodies

Required capabilities

  • Unique identification of medicines and manufacturers
  • A shared product catalogue / registry accessible across countries
  • Secure exchange of regulatory decisions and metadata
  • Standardised data formats for product and regulatory information
  • Integration with national regulatory and procurement systems
  • Product Catalogue / Medicine Registry (CRS Registry)
  • Product Identity
  • Health Data Exchange
  • Terminology & Semantics
  • Audit & Logging

Impact

  • More efficient regulatory processes
  • Faster access to essential medicines
  • Reduced duplication of effort
  • Increased regional alignment and trust
  • Strengthened regulatory capacity across Member States