At this year’s CPHI Americas, ( May 20-22, 2025) attendees with an interest in working with partners in Latin American countries can gain valuable insights into the challenges and opportunities within the evolving regulatory landscape for pharma nearshoring in Latin America. Here, Sandra Sánchez y Oldenhage, President & CEO of PharmAdvice, gives her views.
What are the biggest regulatory hurdles that pharmaceutical companies face when entering the LATAM market?
Pharmaceutical companies face two primary hurdles: the diverse regulatory requirements across countries and the lengthy approval processes. Even when clear timelines are provided, approvals – especially for clinical trials – are often delayed, complicating market entry. Additionally, variations in quality control standards (such as differing GMP requirements and testing protocols) and compliance procedures can lead to uncertainty and increased costs. These challenges necessitate tailored, country-specific strategies to navigate the complex landscape
How do regulatory frameworks differ across major LATAM markets, such as Brazil, Mexico, and Argentina?
Each country has its own regulatory authority with distinct processes and requirements. For example, in Brazil, the Agência Nacional de Vigilância Sanitária (ANVISA) demands a comprehensive dossier review with stringent GMP compliance and has historically long approval timelines. Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) employs a risk-based approach, sometimes expediting approvals via equivalence agreements, yet still presents its own challenges. In Argentina, Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) is evolving with efforts to align with international standards, offering alternative verification routes that can shorten approval times. These differences require companies to develop customized regulatory strategies for each market.
What are some common compliance pitfalls that international pharmaceutical companies encounter in LATAM?
Common pitfalls include underestimating the intricacies of local regulatory requirements, which vary widely even among neighboring countries. Companies may face issues with inconsistent adherence to quality management systems and misalignment with local GMP standards, resulting in launch delays. Additionally, insufficient early engagement with local regulatory bodies often results in unforeseen delays or non-compliance, emphasizing the need for proactive local partnerships and ongoing monitoring of regulatory updates.
What recent regulatory changes in LATAM have impacted the pharmaceutical sector the most, and how should companies adapt?
A significant recent development is the establishment of the Latin American and Caribbean Medicines Agency’s Network (AMLAC – Agencia Reguladora de Medicamentos y Dispositivos Médicos de Latinoamérica y el Caribe) in 2022. While still in its early stages, AMLAC aims to harmonize regulatory processes and expedite drug approvals across member countries. Companies should monitor its progress closely and proactively engage with local authorities to align their submission strategies with these evolving standards, ensuring they remain compliant and competitive.
How will these regulatory challenges be addressed during your discussions at CPHI Americas?
At CPHI Americas, we will discuss best practices for navigating these regulatory complexities. This includes sharing strategies for engaging with local regulators, adapting quality management systems to meet diverse standards, and leveraging collaborative initiatives – such as regional harmonisation efforts to streamline market entry. The goal is to provide actionable insights that help companies overcome these hurdles while enhancing patient access to essential medications.
Nearshoring is becoming a hot topic in pharma – how is it reshaping supply chains in LATAM?
Nearshoring is reshaping supply chains by enhancing agility and resilience, reducing dependency on distant markets like India and China, decreasing lead times, and fostering closer collaboration among local manufacturers and suppliers. This shift not only improves responsiveness to market demands but also strengthens regional supply networks, making them less vulnerable to global disruptions and logistical challenges.
What are the key advantages of nearshoring pharmaceutical production to LATAM instead of relying on Asia?
Key advantages include reduced transportation costs and shorter shipping times due to geographic proximity to major markets like the U.S., which also helps mitigate risks associated with global disruptions. Additionally, nearshoring offers benefits such as aligned time zones for smoother communication, a favorable business environment, and increased opportunities to leverage local expertise and labor – factors that together contribute to a more efficient and resilient supply chain.
What incentives are LATAM governments offering to attract pharmaceutical investment and manufacturing?
Governments are providing tax incentives, simplifying regulatory procedures, investing in infrastructure, and offering financial support for research and development to attract pharmaceutical investments. For instance, Brazil offers significant R&D super-deductions (up to 180%) to boost innovation, while Mexico introduced a decree on October 11, 2023, allocating MXN 30 billion in fiscal incentives to promote nearshoring investments. Argentina, on the other hand, provides tax breaks, special customs regimes, and the development of free zones to encourage manufacturing. These incentives are designed to reduce operational costs and foster local industry growth.
What advice do you have for pharmaceutical companies considering LATAM as a nearshoring destination?
I advise companies to conduct thorough market research to understand local regulatory nuances and cultural differences. It is crucial to assess the availability of skilled labor and evaluate regional infrastructure to support manufacturing operations. Additionally, engaging with local partners can provide valuable insights and facilitate smoother market entry. A strategic, well-researched approach is essential to capitalize on the benefits of nearshoring in Latin America.
What insights can attendees expect from your participation at CPHI Americas, and why is this an important event for the industry?
Attendees can expect an in-depth discussion covering regulatory strategies, the benefits of nearshoring, and ways to build collaborative opportunities in Latin America. CPHI Americas serves as a pivotal platform for industry leaders to exchange knowledge, foster partnerships, and drive innovation in the pharmaceutical sector. I aim to provide practical insights that empower companies to navigate regulatory complexities and seize emerging market opportunities.
* Sandra will be discussing this topic in more detail at CPHI Americas during the panel discussion Breaking Ground Together: Unlocking Collaborative Opportunities in the LATAM Pharma Market.
Author bio:
Sandra Sánchez y Oldenhage is a seasoned life sciences executive with 37 years of leadership experience driving operational growth for top pharmaceutical companies, including Pfizer, Merck Sharp & Dohme, and Novartis, primarily in Latin America.
She has a proven track record in launching and transforming businesses, notably establishing Amgen and Biogen in Mexico as President & GM, leading them to success. Her expertise spans general management, marketing, sales, strategic planning, business development, and government affairs across Latin America, Canada, and parts of Asia.
As founder of PharmAdvice, Sandra provides strategic consulting in commercial strategy, regulatory affairs, government relations, and market access, helping companies navigate transitions, innovation, and market expansion.
A recognized leader, she has been named one of Mexico’s top 50 most powerful businesswomen by CNN Expansion (since 2006), recognized by Forbes (2014), and honored as one of Pharma Exec’s 17 Emerging Pharma Leaders (2015). She was also among 21 global executives selected for the International Women’s Foundation Fellows Program at Harvard and Cambridge.
