Voices of Latin American pharma:
Regulatory challenges & nearshoring opportunities
Ahead of CPHI Americas, we spoke with Isis Valle, senior regulatory specialist at consultancy Franklin da Costa, about the state of the Latin American market
What are the biggest regulatory hurdles that pharmaceutical companies face when entering the Latin American market?
Pharmaceutical companies face significant regulatory challenges when entering this market, primarily due to the lack of a centralised regulatory authority. Each country has its own complex and varied requirements, including differences in drug approval processes, pricing regulations and labelling standards. Additionally, technical-scientific reports and labelling must be presented in the local languages, and having to meet the specific requirements of each country adds even further complexity to market entry. While efforts to harmonise regulations and apply consistent practices across the region have been made, inconsistencies persist, requiring ongoing adaptation to local rules and political shifts.
How do regulatory frameworks differ across major markets?
Regulatory frameworks vary, due to each country’ s unique history, economy and approach to healthcare and health policies. Regulations regarding drug registration, clinical trial requirements and labelling standards differ significantly from country to country. Even key concepts, such as‘ generic’, can differ. For example, while Brazil and Mexico define generics as bioequivalent to the reference product, Argentina adopts a broader definition, including off-patent products that do not need to prove bioequivalence. While Brazil’ s ANVISA’ s regulatory system is strongly influenced by the FDA ' s framework, Mexico ' s COFEPRIS aligns similarly with US standards, reflecting its close commercial ties with the US. In contrast, ANMAT operates with greater flexibility, placing more emphasis on supporting local businesses.
What are some common compliance pitfalls that international pharmaceutical companies encounter in Latin America?
These companies often lack a countryspecific regulatory strategy, because they often assume that the same dossier can be presented across all countries, unaware that each country has its own specific requirements. One common and major compliance pitfall that they encounter is assuming that simple translations from reports and labels created for other markets are accepted. However, technicalscientific reports and labelling must be specifically produced for each market in the local language and meet local regulatory requirements. This misunderstanding often leads to delays and non-compliance, due to incorrect documentation submission and other missteps in drug approval processes. Finally, an inadequate understanding of import and export regulations can result in logistical issues, fines and delays in product distribution.
What recent regulatory changes in Latin American have impacted the pharmaceutical sector the most, and how should companies adapt?
Although regulatory inconsistencies persist in the region, regulatory systems are increasingly aligning with international frameworks, such as the WHO guidelines and the ICH, as well as with EU and US standards. This alignment is further supported by the growing adoption of reliance practices, where local regulatory authorities give significant weight to evaluations performed by trusted agencies. For instance, Brazil’ s Equivalent Foreign Regulatory Authorities( AREE) initiative enables fast-track approval processes for products approved by recognised regulatory bodies. To adapt, companies must also align their practices with global safety, efficacy, and quality standards. We strongly recommend building local partnerships to navigate country-specific requirements and
Valle – Regulatory frameworks in Latin American countries can vary considerably
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