Opportunities and Challenges in the Latin American Pharmaceutical Industry

Published 28th March 2024

Whitepaper Opportunities & Challenges in the Latin American Pharmaceutical Industry - icon

Latin American pharmaceutical industry faces competition from both local and international players. India has emerged as the world’s leading exporter of generic medicines. The pharmaceutical market in the region has experienced a steady growth in recent years. India and China face intense competition from generic drug manufacturers.

This systematic comparison process aimed to ensure consistency and alignment in regulatory requirements across different markets, facilitating the development of a core dossier approach that could streamline the regulatory submission process for products in Latin America and the EU.

The regulatory landscape in Latin America (LatAm) presents a blend of challenges and opportunities for pharmaceutical investment and expansion. Despite variations in regulatory systems across the region, concerted efforts have been made to fortify regulatory frameworks, establish quality review mechanisms, and adopt risk-based approaches. Initiatives like the EU-MERCOSUR agreement and the development of a LatAm Technical Core Dossier are geared towards simplifying regulatory procedures and fostering harmonization, which in turn, benefits both pharmaceutical companies, national health authorities and patients. This streamlined approach not only reduces the complexity of dossier customization but also enhances efficiency, facilitating quicker market access for groundbreaking medicines and ensuring uniform regulatory adherence. Looking ahead, sustained collaboration between regulatory bodies and industry stakeholders remains pivotal in optimizing the deployment of LatAm Technical Core Dossiers and maximizing the potential of regulatory convergence within the EU-Latin America MERCOSUR Agreement. Through collective efforts, regulatory agencies and pharmaceutical enterprises can more adeptly navigate regulatory hurdles, ultimately advancing the well-being of patients and public health outcomes throughout the LatAm region.


whitepaper - Opportunities and Challenges in the Latin American Pharmaceutical Industry Cover

Meet The Author

Miguel Lewis, Senior Regulatory Consultant, DLRC Group

Miguel is currently a Senior Regulatory Consultant at DLRC, where he has been since November 2019, leveraging over 18 years of regulatory experience. Previously, at PRA Health Science/Takeda, he specialised in regulatory affairs across drug development phases, particularly in gastrointestinal and oncology areas. In his role as European Team Lead, Miguel provided oversight and training for regulatory activities while also serving as the Global/EU/EM Regulatory Affairs lead for multiple products. His expertise spans preparing and submitting Phase 1-3 CTAs, managing various regulatory procedures, and post-licensing activities. With a background in pharmacy and an MSc in Pharmaceutical Technology, Miguel’s regulatory acumen extends across diverse therapeutic areas and pharmaceutical forms, contributing significantly to DLRC’s regulatory strategies and pharmaceutical innovations.

Meet the team
Miguel Lewis, Senior Regulatory Consultant, DLRC Group

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