Overview and Lifecycle Management of Generic Pharmaceutical Drugs in Mexico, Guatemala and Brazil

Abstract

Objective: The generic pharmaceutical markets in Mexico, Guatemala, and Brazil are influenced by distinct regulatory frameworks, production and distribution dynamics, and marketing strategies, which shape lifecycle management. Regulatory policies, market competition, and healthcare initiatives impact accessibility, affordability, and quality, presenting both challenges and opportunities for enhancement in these areas.

Summary: This thesis offers an in-depth examination of lifecycle management strategies in the generic pharmaceutical markets of Mexico, Guatemala, and Brazil. Generic drugs are crucial for increasing access to affordable healthcare, especially in emerging economies. Through comparative analysis, this research explores the regulatory frameworks, market dynamics, and key challenges in the development, approval, marketing, and post-marketing surveillance of generic drugs in these three Latin American countries.

The study starts with an overview of the regulatory landscape for generic pharmaceuticals in Mexico, Guatemala, and Brazil, highlighting similarities and differences in registration requirements, approval processes, and post-approval obligations. It investigates the roles of regulatory agencies like COFEPRIS, DIGEMID, and ANVISA in ensuring the quality, safety, and efficacy of generic drugs throughout their lifecycle. Additionally, the research delves into the strategies used by pharmaceutical companies for lifecycle management of generic drugs, including variations, biowaivers, and labeling changes.

Real-world case studies illustrate post-approval changes and their regulatory implications in each country, providing insights into the complexities of managing generic drug portfolios in different regulatory environments. The thesis also examines the market dynamics affecting the availability, pricing, and accessibility of generic drugs in Mexico, Guatemala, and Brazil. Factors such as patent expirations, competition, healthcare policies, and public procurement practices are analysed to understand their impact on market entry, competition, and the affordability of generic drugs. Furthermore, the study addresses the challenges and opportunities in pharmacovigilance and post-marketing surveillance of generic drugs, emphasizing the need for robust systems to detect and manage adverse drug reactions and ensure patient safety.

Conclusion: The key findings highlight regulatory frameworks, market dynamics, and lifecycle management strategies in the generic pharmaceutical markets, identifying challenges and opportunities. The study reflects on implications for stakeholders and suggests areas for future research to enhance accessibility, affordability, and quality.