Guatemala Healthcare Registration Delays

U.S. companies report persistent delays in obtaining and renewing sanitary registrations for medicines and related products in Guatemala. The regulator, the Ministry of Public Health and Social Assistance (MSPAS), through the Department of Regulation and Control of Pharmaceutical and Related Products (DRCPFA), continues to process paper-heavy applications under Central American Technical Regulations (RTCA), with five-year certificate validity and separate procedures for new registrations and renewals. In practice, backlogs and limited access to evaluators slow reviews, extending time to market for both first-time filings and renewals.

Stakeholders also note that dossier “updates” tied to product or label changes can be treated as new submissions, adding further uncertainty to renewal timelines. While Guatemala recognizes regional RTCA frameworks and maintains pathways such as homologation (expedited) and mutual recognition, companies still encounter administrative roadblocks that reduce efficiencies and prolong clearance.

The current efforts by the Government of Guatemala to digitalize the process should expedite both the application and renewal process for sanitary registrations. However, this process has also been fraught with delays. Although a clear timeframe has not yet been confirmed, initial indications suggest that digitalization could be in place by the end of this calendar year.

Given these conditions, U.S. exporters should plan for longer lead times, build conservative launch calendars, and engage early with local regulatory agents to review documentation in advance (e.g., Pharmaceutical Product Certificates, GMP evidence, and RTCA-aligned forms). Monitoring MSPAS procedural notices and using recognition routes where possible can help mitigate delay risk, but firms should still budget additional time for both new applications and renewals.

For more information, please contact: Karla.Salas@trade.gov.