INVIMA issued Resolution No. 2026025611 on 21-May-2026, adopting a contingency plan aimed at rationalizing, simplifying, and automating procedures for the issuance, modification, and management of sanitary registrations and related regulatory processes. The plan introduces a risk-based regulatory approach, AI-supported tools, and prioritization mechanisms to address backlogs and ensure medicine availability.

Policy Focus:

  • Adoption of a contingency plan for rationalization, simplification, automation, and digital transformation of sanitary registration and variation procedures.

Scope:

  • Applicable to all registration, monitoring, and control procedures managed by INVIMA's Directorate of Medicines and Biological Products, covering biologics, medical gases, medicinal products, and homeopathic drugs.

Key Requirements / Provisions:

  • Risk-Based Model: Post-market/control verification approach maintaining existing technical and quality requirements.
  • Prioritization Mechanisms: Manufacturing site additions/substitutions and manufacturer transfers prioritized to prevent medicine shortages.
  • Accelerated Pathways: New drug registration applications not requiring Commission Review or BD/BE studies eligible for accelerated assessment.
  • Expanded Scope: Registration cancellations/suspensions, import-export authorizations, and administrative appeals included.
  • AI Integration: Formal incorporation of AI tools for application classification, prioritization, and monitoring with mandatory human oversight; no AI-based regulatory decision-making.
  • GMP Certificate Acceptance: Electronic verification through official foreign regulatory authority websites accepted as evidence.

Regulatory Goals:

  • Reduce procedural backlogs and improve market access timelines.
  • Incorporate digital transformation and AI in regulatory operations.
  • Ensure medicine supply continuity.

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