Elevating Pharmaceutical Standards: INVIMA and USP Forge Stronger Alliance

Colombia’s National Food and Medication Surveillance Institute (INVIMA) is set to enhance its collaborative efforts with teh United States Pharmacopeia (USP) throughout 2025. This renewed partnership aims to bolster the nation’s regulatory framework, broaden access to safe and effective medicines, and reinforce stringent quality control protocols within the pharmaceutical sector.

The decision to deepen ties followed a productive meeting between INVIMA’s Director-General, Francisco Rossi, and USP’s CEO, Ronald T.Piervinnzi. Both leaders lauded the accomplishments achieved since the collaboration’s inception in 2014 and charted a course for expanded joint initiatives in the coming year.

A Decade of Progress: Leveraging Technical Expertise for Enhanced Oversight

For over a decade, INVIMA has benefited from USP’s support through the Preferential Access Program for Regulators (PAR). This initiative provides crucial assistance to health agencies across Latin America on pivotal regulatory matters. In Colombia, the Directorate of Biological medicines and products, along with the Office of Laboratories and Quality Control, have especially benefited, strengthening their capabilities in medicine surveillance, inspection, and analysis.

This alliance has granted INVIMA preferential access to vital reference standards, advanced analytical tools, and the USP-NF online platform. The USP-NF, a continuously updated resource integrating the American Pharmacopoeia and the National Formulary, ensures access to the highest quality benchmarks for pharmaceutical products. This is particularly vital as the pharmaceutical industry faces increasing scrutiny regarding drug quality and safety.

Training and Skill Enhancement: Empowering INVIMA Professionals

INVIMA personnel have actively participated in certified courses and technical sessions, focusing on critical areas such as:

• Analytical method verification and transfer
• Nitrosamine impurities
• Advanced therapy medicinal products
• Stability and dissolution testing
• Gas chromatography fundamentals
• Impurities and degradation products
• Out-of-specification results
• In vivo-in vitro correlation
• Solution method development and validation
• Extractables and leachables

This comprehensive training has significantly contributed to building institutional capacity, ensuring the quality, safety, and efficacy of medications available in Colombia.

looking Ahead: Renewed Commitment and Strategic Alignment

A key outcome of the recent bilateral discussions was the mutual commitment to renewing the memorandum of understanding, initially signed in august 2022 and valid for three years. This renewal will not only deepen the existing collaboration but also broaden its reach to encompass other Colombian public entities involved in health surveillance.

Moreover, the Directorate of Medicines and Biological Products at INVIMA will participate in the USP 2025 Convention, a high-level forum for establishing strategic resolutions for the next five years. Key priorities guiding the USP agenda and its regulatory partners include:

• Expanding access to biological products
• Improving quality in digital health technologies
• Reducing impurities in medicines
• Mitigating drug shortages
• Strengthening regulatory systems for resilient supply chains

A Holistic Approach to Regulatory Advancement

INVIMA has reaffirmed its dedication to leveraging international cooperation as a cornerstone for building a robust, modern, and interconnected regulatory system. The institute aims to extend the benefits of the alliance with USP to other public entities in Colombia, facilitating the adoption of harmonized quality standards and access to advanced analytical methodologies, aligning with global best practices.

this alliance with the USP is key to continuing to strengthen the national regulatory capacity and ensure that pharmaceutical products in Colombia comply with the highest standards of quality and safety.
Francisco Rossi, General Director of INVIMA

by solidifying this technical cooperation, Colombia is taking a notable step towards a more efficient and scientifically grounded regulatory framework, ultimately prioritizing the protection of public health in an increasingly interconnected and demanding global landscape. This proactive approach is essential for maintaining public trust and ensuring access to safe and effective medications for all Colombians.