Colombia Healthcare Pharmaceutical Regulatory Acceleration

The National Institute for Drug and Food Surveillance (INVIMA) has implemented Resolution 2025010547 of 2025, effective March 19, 2025, to streamline the approval process for over 14,000 pending sanitary registrations and related pharmaceutical procedures. This regulatory adjustment introduces a six-month Contingency Plan to strengthen procedural efficiencies and reduce bureaucratic delays. The resolution seeks to expedite approvals while maintaining compliance with national and international standards by optimizing the Directorate of Medicines and Biological Products’ capabilities.

The initiative includes procedural adjustments, such as directly engaging applicants to resolve documentation issues efficiently and adopting digital tools to enhance communication. By incorporating information and communication technologies, INVIMA aims to accelerate decision-making processes for product approvals and distribution authorizations, ensuring that pharmaceutical companies experience fewer administrative bottlenecks and can swiftly bring essential medicines to market. The resolution also establishes a Technical Committee composed of INVIMA and Ministry of Health officials to oversee and assess the execution of the Contingency Plan.

For more information reach out to:
Rafael Jimenez
Commercial Specialist
Rafael.Jimenez@trade.gov