Applied Drug Research, Clinical Trials and Regulatory Affairs - Volume 10, Issue 1, 2024

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, post-marketing 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.

Treatment of complicated fatal diseases was difficult when nanotechnology was not more popular. The incorporation of nanomedicine has increased in the last 13 years, even though regulatory guidelines regarding nanomaterials and nanomedicine weren't sufficient. Hence, it was tough to decide valid inevitability for the manufacturers, administrators, health professionals, primary care providers, and rest of the public that could ultimately have a negative impact on the financing system, research, and development of such items, affecting the approval of the public and acceptance of nano-products. This review includes coverage across the therapeutic value of nanomaterials, problems in the regulation, regulatory challenges, synthesis, physicochemical properties, and clinical application. The hurdles to using nanotechnology, particularly in the pharmaceutical development of novel medicinal products and respective regulatory issues, are critically explored, considering the characteristics offered by the nanomaterials.