Regulatory Reliance in Latin America: Opportunities and Implementation Challenges for International Pharmaceutical Companies.

Authors

Esteban Ortiz-Prado, Jorge Vasconez-Gonzalez, Dina Albuja Tapia, Diana Dominguez, Paola Edith Hernández-Montenegro, Stefanie B Samaniego-Cameron, Juan S Izquierdo-Condoy

Published in

Therapeutic innovation & regulatory science. Sep 15, 2026. Epub Sep 15, 2026.

Abstract

Regulatory reliance is increasingly used to reduce unnecessary duplication in pharmaceutical regulation, but its legal basis, operational depth, and effect on review time vary substantially across Latin America. This structured narrative policy and practice review maps publicly documented reliance, recognition, verification, abridged/optimized review, homologation, and related facilitated pathways for human medicinal products in selected Latin American jurisdictions. Primary legal instruments and national regulatory authority (NRA) guidance were prioritized, supplemented by WHO/PAHO frameworks, peer-reviewed literature, and selected specialist regulatory sources. Extracted domains included the existence of a written legal or policy basis, pathway status, product eligibility, reference-authority criteria, product-sameness requirements, use of reference-agency assessment reports, local quality/safety/efficacy review, CPP and GMP requirements, pharmacovigilance obligations, and standard versus reliance-specific timelines. The evidence shows marked heterogeneity: some jurisdictions have formal, product-specific reliance procedures, whereas others use partial mechanisms, regional mutual-recognition arrangements, or pathways that remain under implementation. Publicly available reliance-specific review times are sparse and are rarely stratified by new active substances, generics, biosimilars, biologics, or vaccines; therefore, observed or reported timelines should not be interpreted as a uniform causal effect of reliance. For international pharmaceutical sponsors, prior approval by a trusted authority may support a facilitated pathway only when the receiving NRA's legal basis, product scope, dossier sameness, documentary requirements, and post-market obligations are satisfied. Greater transparency on review depth, assessment-report access, and product-level performance metrics is needed to determine the real-world impact of regulatory reliance in the region.

PMID:
42742915
Bibliographic data and abstract were imported from PubMed on 16 Sep 2026.

Read full publication at:
Please sign in to see all details.

Stats

1-terrible, 9-excellent. How would you rate this publication? Sign in in to submit your rating.

Post a comment

You need to be signed in to post comments. You can sign in here.

Comments

There are no comments yet.