Title:Pharmaceutical Market Access in Latin America: Analyzing Approval
Requirements in Three Key Nations: Ecuador, Dominican Republic and
Nicaragua
Volume: 10
Author(s): Jhanvi Thakkar, Ayush Patel, Jagruti Desai, Mehul Patel, Umang Shah, Ashish Patel, Krishi Patel and Swayamprakash Patel*
Affiliation:
- Department of Pharmaceutics, Ramanbhai Patel College of Pharmacy, Charotar University of Science and Technology
(CHARUSAT), CHARUSAT Campus, Changa, 388421, India
Keywords:
Legal frame work, pharmaceutical drug, scientific accuracy, trade deficit, life sciences, lucrative market.
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.
