Regulatory discrepancies and patient-safety risks from the continued marketing of withdrawn medicines in Ecuador, Colombia, and Peru (2014–2025)

Substantial misalignment persists between international and Andean regulatory decisions. The continued regulatory authorization of withdrawn medicines highlights weaknesses in pharmacovigilance and transparency, underscoring the urgent need for regional harmonization and public disclosure of regulatory actions.

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Publication Details

Journal
Drug Metabolism and Personalized Therapy
Published
2026-03-13
DOI
https://doi.org/10.1515/dmpt-2025-0081
Primary Topic
Pharmacovigilance and Adverse Drug Reactions
Type
article
Field-Weighted Citation Impact
0.00
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article

Regulatory discrepancies and patient-safety risks from the continued marketing of withdrawn medicines in Ecuador, Colombia, and Peru (2014–2025)

Enrique Terán, Aida Miranda, Ariel Moncayo, Shabnam Santos et al.
Drug Metabolism and Personalized Therapy
Pharmacovigilance and Adverse Drug Reactions
article

Regulatory discrepancies and patient-safety risks from the continued marketing of withdrawn medicines in Ecuador, Colombia, and Peru (2014–2025)

Enrique Terán, Aida Miranda, Ariel Moncayo, Shabnam Santos, Camila D Lopez, Fatima Morales
article en

Abstract

Substantial misalignment persists between international and Andean regulatory decisions. The continued regulatory authorization of withdrawn medicines highlights weaknesses in pharmacovigilance and transparency, underscoring the urgent need for regional harmonization and public disclosure of regulatory actions.

Drug Metabolism and Personalized Therapy
Escuela Superior Politécnica del Chimborazo (EC), Universidad San Francisco de Quito (EC), Universidad de Sevilla (ES), Temple University (US)
Openalex Percentile: Top 19%
Pharmacovigilance and Adverse Drug Reactions
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