Colombia Healthcare Sanitary Registration Backlog

INVIMA, Colombia’s National Food and Drug Surveillance Institute (similar to the FDA in the United States), faces significant challenges in granting sanitary registration. The regulatory body has been dealing with a growing backlog of applications, resulting in delays for businesses looking to enter and expand within the Colombian healthcare market.

Several factors contribute to INVIMA’s backlog, including outdated technology, limited budgetary resources, and the repercussions of recent cybersecurity attacks. These challenges are further exacerbated by external pressures such as an increasing volume of applications, complex regulatory processes, and stringent local requirements that often exceed international standards. Additionally, in-country testing requirements for imported medicines add to the delays, hindering the timely approval of pharmaceutical products and medical devices in Colombia. This situation ultimately affects the industry and restricts patient access to necessary medications.

The backlog in approving sanitary registrations and processing post-approval changes (PACs) presents considerable obstacles for international pharmaceutical and medical device companies operating in Colombia. Lengthy approval times lead to delayed market entry and shorter product lifecycles, impacting companies’ revenue potential and market strategies. Furthermore, these delays increase costs due to maintaining multiple versions of registration dossiers and managing complex supply chains.

For more information about how Invima´s backlog could impact U.S. Exporters to Colombia, reach out to:

Rafael Jimenez
Commercial Specialist
Rafael.Jimenez@trade.gov