Login Register Cart 0
Generic placeholder image

Applied Drug Research, Clinical Trials and Regulatory Affairs

Editor-in-Chief

ISSN (Print): 2667-3371
ISSN (Online): 2667-338X

Back
Journal Home About Journal Editorial Board Current Issue Volumes/Issues
Subscribe
Review Article

Pharmaceutical Market Access in Latin America: Analyzing Approval Requirements in Three Key Nations: Ecuador, Dominican Republic and Nicaragua

Author(s): Jhanvi Thakkar, Ayush Patel, Jagruti Desai, Mehul Patel, Umang Shah, Ashish Patel, Krishi Patel and Swayamprakash Patel*

Volume 10, 2024

Published on: 23 May, 2024

Article ID: e230524230257 Pages: 18

DOI: 10.2174/0126673371287527240502114352

Price: $65

Abstract

This article presents a comprehensive and comparative analysis of the regulatory frameworks governing the approval of pharmaceuticals in the Dominican Republic, Ecuador, and Nicaragua. It delves into the intricate scientific terminology and complex procedures inherent in these regulatory systems, shedding light on the demanding requirements that pharmaceutical companies must fulfil to secure market access in these countries. Employing a comparative approach, the article explores both the analogy and differences in the approval processes, focusing on factors such as safety standards, efficacy assessments, clinical trial prerequisites, postmarketing surveillance, and overall transparency. The findings contribute to a deeper understanding of the scientific accuracy and ongoing efforts towards regulatory harmonisation within the pharmaceutical industry across these countries. Furthermore, this study aims to define the regulatory requirements for drug approval in the LATAM region, explicitly emphasising the Dominican Republic, Ecuador, and Nicaragua. It provides insights into the current pharmaceutical market landscape in Latin America, compares the regulatory requirements for drug approval in these three countries, and offers guidance on preparing dossiers for obtaining authorisation of pharmaceutical drug products. By examining the similarities and differences in regulatory standards, this article facilitates a comprehensive understanding of the stringency ratios between these countries and assists companies in navigating the specific regulatory landscapes to achieve successful drug approvals.

[1]
Alejandro CFD. Latin America in the 1930s.Modern Political Economy And Latin America. London: United Kingdom: Routledge 2018; pp. 140-51.
[2]
Singam SLSR, Yetukuri K, Nadendla RR. Drug registration requirements for pharmaceuticals in emerging markets. Int J Drug Reg Affairs 2020; 8(4): 73-82.
[http://dx.doi.org/10.22270/ijdra.v8i4.442]
[3]
Ramírez-Telles M, Argotti-Rodríguez U. Regulation of drug prescribing information in Latin America and the Caribbean. Ther Innov Regul Sci 2022; 56(4): 536-51.
[http://dx.doi.org/10.1007/s43441-022-00396-y] [PMID: 35380375]
[4]
Statista. Pharmaceutical imports and exports of major Latin American countries in 2022. 2022. Available From: https://www.statista.com/statistics/418042/pharma-imports-and-exports-in-latin-america-by-major-country/
[5]
Prat AG. A practical overview of requirements for drug registration in Latin America. Reg Rapporteur 2013; 10(9): 5-10.
[6]
Lemke C. Supporting the value proposition of the pharmaceutical industry in Mexico 2016. Available From: https://www.wifor.com/uploads/2019/02/WifOR_AMIIF_Value_Proposition_of_Pharma_Industry_in_Mexico-1.pdf
[7]
Sravani M, Kusuma M, Prabhahar A, Nadendla R. Registration of generic drugs in Central America and Mexico. Int J Pharma Chem Res 2017; 3(3): 635-50.
[8]
Reddy M. Latin American Pharmaceutical Regulatory environment–review article. Int Res Pharm Nano Sci 2014; 3: 122-31.
[9]
Pilamala Rosales A, Linnemann AR, Luning PA. A Net-Map analysis to understand the roles and influence of stakeholders in street food safety - A study in Ecuador. Food Control 2023; 154: 109966.
[http://dx.doi.org/10.1016/j.foodcont.2023.109966]
[10]
WDA. Pharmaceutical products registration in dominican republic 2023. Available From: https://wdalaw.com/publications/articles/natural-productsregistration-in-dominican-republic.php
[11]
Orozco-Solares TE, León-Moreno LC, Rojas-Rizo A, Manguart-Páez K, Caplan AI. Allogeneic mesenchymal stem cell-based treatment legislation in Latin America: The need for standardization in a medical tourism context. Stem Cells Dev 2022; 31(7-8): 143-62.
[http://dx.doi.org/10.1089/scd.2022.0013] [PMID: 35216516]
[12]
Vásquez AGT. Risk based approach of post-approval changes in central America and Dominican republic, identifying opportunities for convergence with EMA and FDA 2021.
[13]
Bendaña PB. Requirements for pharmaceutical regulatory affairs in Nicaragua 2019. Available From: https://pharmaboardroom.com/legal-articles/requirements-forpharmaceutical-regulatory-affairs-in-nicaragua/
[14]
Ortiz-Prado E. Health status and medication consumption in Ecuador 2015. Available From: https://www.researchgate.net/publication/292610565_HEALTH_STATUS_AND_MEDICATION_CONSUMPTION_IN_ECUADOR
[15]
Wilbert Bannenberg VK. Regional assessment of drug registration and regulatory systems in CARICOM member states and the dominican republic. CARICOM Regional Assess Drug Reg Regul Syst 2009; I: 61.
[16]
Tejera E, Sánchez ME, Henríquez-Trujillo AR, Pérez-Castillo Y, Coral-Almeida M. A population-based study of preeclampsia and eclampsia in Ecuador: Ethnic, geographical and altitudes differences. BMC Preg Childbirth 2021; 21(1): 116.
[http://dx.doi.org/10.1186/s12884-021-03602-1] [PMID: 33563238]
[17]
Durán C. Regulation, consumption and expenditures of new cancer drugs in Ecuador and Latin America 2021.
[18]
Rayuela Radio SD, De La Judicatura C. Access to Drugs and the Situation of the Pharmaceutical Market in Ecuador 2020. Available From: https://www.fisd.in/sites/default/files/Publication/ITEC%20Report%20on%20Science%20Diplomacy%202020_Webmin%20%281%29.pdf
[19]
De Paepe P, Tapia RE, Santacruz EA, Unger JP. Ecuador’s silent health reform. Int J Health Serv 2012; 42(2): 219-33.
[http://dx.doi.org/10.2190/HS.42.2.e] [PMID: 22611652]
[20]
Legal-Team-Ecuador. Product registration in Ecuador Can be Straightforward 2021. Available From: https://www.bizlatinhub.com/product-registration-ecuador/
[21]
Petrick HJ. Song text and song structure: With an emphasis on oral/aural tradition 2023. Available From: https://digitalcommons.liberty.edu/cgi/viewcontent.cgi?article=1995&context=masters
[22]
Liz Liriano H. El gas natural como una fuente potencial para el desarrollo energético sostenible en la República Dominicana: Una revisión. Ciencia Ambiente y Clima 2022; 5(1): 39-52.
[23]
Keys HM, Kaiser BN, Foster JW, et al. Cholera control and anti-Haitian stigma in the Dominican Republic: From migration policy to lived experience. Anthropol Med 2019; 26(2): 123-41.
[http://dx.doi.org/10.1080/13648470.2017.1368829] [PMID: 29058456]
[24]
World Health Organization. Pharmaceuticals in the Americas 1995.
[25]
Youngers C, Rosin E. Drugs and democracy in Latin America: The impact of US policy. Boulder, Colorado: Lynne Rienner Pub 2005.
[26]
Chapman HJ, Veras-Estévez BA, Pomeranz JL, Pérez-Then EN, Marcelino B, Lauzardo M. Perceived barriers to adherence to tuberculosis infection control measures among health care workers in the Dominican Republic. MEDICC Rev 2017; 19(1): 16-22.
[http://dx.doi.org/10.37757/MR2017.V19.N1.4] [PMID: 28225541]
[27]
Sadler K, Wilson K. Dominican Republic: A guide for global health workers, medical practitioners, and NGO volunteers. Chicago: Dartmouth College Press 2015; p. 71.
[28]
Kelleher SP, Reyes D. Technical measures to trade in Central America: Incidence, price effects, and consumer welfare 2014. Available From: https://ideas.repec.org/p/wbk/wbrwps/6857.html
[29]
WDA. WDA LAW 2024. Available From: https://wdalaw.com/about-wda.php
[30]
U.S. Department of State. The Dominican Republic. In: 2018. Available From: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190334
[31]
Lausanne Rd. Pharmaceuticals, cosmetics, personal hygiene products and domestic hygiene products 2023. Available From: https://importlicensing.wto.org/content/pharmaceuticals-cosmeticspersonal-hygiene-products-and-domestic-hygiene-products-0
[32]
Logistics Clustetr. 12 Dominican republic regulatory departments and quality control 2022. Available From: https://dlca.logcluster.org/12-dominican-republic-regulatorydepartments-and-quality-control
[33]
WHO. Guidelines for diagnosing and managing disseminated histoplasmosis among people living with HIV 2020. Available From: https://www.who.int/publications/i/item/9789240006430
[34]
Bledel EE. Food regulation in Latin America. Food Drug Cosmet Law J 1973; 28(9): 585-95.
[35]
Sanitary registration in Nicaragua. 2017. Available From: https://alvaradoyasociadoslegal.com/english-blog/sanitary-registration-in-nicaragua/
[36]
Taft-Morales M. Nicaragua: In brief 2016. Available From: https://sgp.fas.org/crs/row/R44560.pdf
[37]
Durán CE, Cañás M, Urtasun MA, et al. Regulatory reliance to approve new medicinal products in Latin American and Caribbean countries. Rev Panam Salud Publica 2021; 45: 1-10.
[http://dx.doi.org/10.26633/RPSP.2021.10] [PMID: 33859678]
[38]
Patel P, Badjatya JK, Hinge M. Comparative study of regulatory requirements of Drug Product in Emerging market. Int J Drug Regul Aff 2019; 7(3): 48-62.
[http://dx.doi.org/10.22270/ijdra.v7i3.350]
[39]
Homedes N, López Linares R, Ugalde A. Generic drug policies in Latin America 2005. Available From: https://documents.worldbank.org/en/publication/documentsreports/documentdetail/945221468269681466/generic-drug-policies-in-latin-america
[40]
Sanitary registration. 2018. Available From: https://proassem.com/en/sanitary-registration/
[41]
Bastian S. Drug regulation in Latin America: A guide for small business 2012. Available From: http://consulting-forpharma.com/fileadmin/user_upload/documents/RA_in_LATAM_cfp.pdf
[42]
PharmaBoardroom. Marketing, manufacturing, packaging & labelling, advertising 2018. Available From: https://pharmaboardroom.com/legal-articles/marketingmanufacturing-packaging-labelling-india/
[43]
Badjatya JK. Overview of drug registration requirements for pharmaceuticals in emerging market. J Drug Deliv Ther 2013; 3(2)
[http://dx.doi.org/10.22270/jddt.v3i2.466]
[44]
Mohit Deep A, Khurana G, Kumar J, Monga A. Comparison of basic regulatory requirements for generic drug products registration in CIS and Latin American Countries. Appl Clin Res Clin Trials Regul Aff 2020; 7(2): 117-25.
[http://dx.doi.org/10.2174/2213476X06666191023093840]
[45]
Jakovljevic M, Cerda AA, Liu Y, et al. Sustainability challenge of Eastern Europe—historical legacy, belt and road initiative, population aging and migration. Sustainability (Basel) 2021; 13(19): 11038.
[http://dx.doi.org/10.3390/su131911038]
[46]
Schellekens R, Smith J. Synthesis of Multifunctional Hybrid Semiconductor NanomaterialsMultifunctional Hybrid Semiconductor Photocatalyst Nanomaterials. Berlin, Heidelberg: Springer 2023; pp. 31-51.
[http://dx.doi.org/10.1007/978-3-031-20298-8_35]
[47]
Vogler S. Prices of new medicines: International analysis and policy options. Z Evid Fortbild Qual Gesundhwes 2022; 175: 96-102.
[http://dx.doi.org/10.1016/j.zefq.2022.09.009] [PMID: 36372642]
[48]
Nwokike J. Regulatory reliance and post-marketing surveillance systems for safe and accelerated introduction of new medical products in low-and middle-income countries 2023.
[49]
Pucik V, Evans P, Bjorkman I, Jhaveri K. The global challenge: International human resource management. Thousand Oaks, California: SAGE Publications 2016.
[50]
Kohtamäki M, Rabetino R, Einola S, Parida V, Patel P. Unfolding the digital servitization path from products to product-service-software systems: Practicing change through intentional narratives. J Bus Res 2021; 137: 379-92.
[http://dx.doi.org/10.1016/j.jbusres.2021.08.027]
[51]
Shah S, Nene S, Rangaraj N, Raghuvanshi RS, Singh SB, Srivastava S. Bridging the gap: Academia, industry and FDA convergence for nanomaterials. Drug Dev Ind Pharm 2020; 46(11): 1735-46.
[http://dx.doi.org/10.1080/03639045.2020.1821055] [PMID: 32901536]
[52]
Peters K. A comparative overview of the regulatory landscapes around real-world data/real-world evidence in the USA and the EU, and the wider perspective 2022. Available From: https://www.dgra.de/media/pdf/studium/masterthesis/master_peters_karla_2022.pdf
[53]
Rivera VM, Macias MA. Access and barriers to MS care in Latin America. Mult Scler J Exp Transl Clin 2017; 3(1)
[http://dx.doi.org/10.1177/2055217317700668] [PMID: 28607755]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy