The Resolution incorporates automation tools, the gradual use of artificial intelligence, evaluation methodologies through interdisciplinary “working cells,” and prioritization mechanisms for procedures related to the risk of medicine shortages. Likewise, it maintains the obligation to fully comply with the technical, pharmaceutical, and health requirements established under current regulations, expressly clarifying that the Plan does not modify the substantive regulatory standards.
One of the most relevant aspects corresponds to Article 8, through which INVIMA formally adopts the principles of “regulatory trust and reliance.” This provision establishes that new marketing authorizations that have received prior approval from reference health authorities may be prioritized within the Institute’s evaluation system. Nevertheless, the regulation expressly clarifies that INVIMA will retain the substantive assessment and final administrative decision in all cases.
Additionally, the Resolution provides that, within one month following its entry into force, INVIMA will issue the legal instrument regulating the use of regulatory decisions from other jurisdictions. This mechanism will allow the use of technical assessments issued by foreign regulatory agencies to optimize resources and strengthen national regulatory decision-making, in line with international trends toward regulatory convergence and reliance.
Unlike the contingency plans issued by INVIMA in 2025, which were primarily focused on the prioritization of procedures related to medicine shortages and operational strengthening, the new 2026 Plan introduces a more structured and modern regulatory approach by formally incorporating the principle of “Reliance” or regulatory trust as a tool to optimize and prioritize the evaluation of procedures that have received prior approvals from reference health authorities.
