Volume : 11, Issue : 11, November – 2024

Title:

COMPREHENSIVE AND COMPARATIVE STUDY ON APPROVAL PROCESS OF GENERIC DRUGS PRODUCTS IN LATIN AMERICAN COUNTRIES

Authors :

P SAI RAM*, M. V. NAGABHUSHANAM, G RAMAKRISHNA, M BEENA DEVI

Abstract :

This study provides a comprehensive and comparative analysis of the regulatory approval processes for generic drug products across Latin American countries. With the rising need for affordable medications, generic drugs play a critical role in expanding healthcare access. However, significant differences exist in the regulatory frameworks and approval timelines in Latin America, impacting the availability and affordability of generics. This research examines the requirements, documentation, bioequivalence studies, and timelines mandated by key regulatory bodies, including ANVISA (Brazil), COFEPRIS (Mexico), INVIMA (Colombia), and others. Key findings reveal a substantial variance in approval times and procedural complexity, with some countries implementing stringent regulatory processes, while others face challenges such as limited resources, capacity constraints, and bureaucratic delays. The study also explores efforts toward regional harmonization led by organizations like PAHO and PANDRH, which aim to standardize regulations across Latin America to streamline approval processes. Through comparative analysis, this research identifies best practices and recommends improvements, such as greater regional collaboration, capacity building for regulatory agencies, and simplified approval pathways. These recommendations aim to facilitate faster, safer, and more cost-effective access to generic drugs in Latin America, ultimately supporting public health goals by making essential medications more accessible to diverse populations across the region.
Keywords: Latin American countries, Regulatory frameworks, Approval Process, Generic Drugs

Cite This Article:

Please cite this article in press P Sai Ram et al Comprehensive And Comparative Study On Approval Process Of Generic Drugs Products In Latin American Countries.,Indo Am. J. P. Sci, 2024; 11 (11).

Number of Downloads : 10

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