Pivotal regulatory reform, digitalisation and improved regional cooperation are transforming countries such as Argentina, Brazil, Mexico, and other Latin America (LATAM) markets into increasingly attractive locations for conducting clinical trials.
In addition, acceptance and understanding of the clinical trial process have improved due to the Covid-19 pandemic, with clinical research gaining favourable media attention in the LATAM region.
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“Many countries are now considering clinical research of national interest”, said Paola Gaglio, clinical trial manager lead LATAM at Boehringer Ingelheim, speaking at the Clinical Trials in Oncology Europe 2025 conference on 26 November.
Gaglio added: “They are looking forward to leaner processes, with shorter and reliable timelines.”
Most recently, regulatory updates in Argentina in the form of the National Administration of Drugs, Food and Medical Devices (ANMAT) Disposition 7516/2025 commenced on 1 December 2025. These changes will ensure the country is aligned with the (ICH) E6 (R3) Good Clinical Practice (GCP) guidelines and cap the maximum approval timeline at 62 days. Further, ethical review of new drugs is now fully delegated to the ethics committee and can be conducted in parallel to regulatory review.
Meanwhile, Gaglio said that importing in Brazil can now commence one month after submission of a new drug for regulatory review, instead of waiting for approval. She added that the adoption of new regulations last year led to a dramatic reduction in regulatory review from 265 days to a maximum of 90 days.
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By GlobalDataMexico is also introducing regulatory reform and aiming to increase its annual investment in clinical research from $200m to $2bn by 2030.
Key challenges for clinical trials in the LATAM region
Another key aspect of the LATAM region’s transition into a more desirable one for drug development is its enhanced technological capabilities.
“Digitalisation is now a reality,” said Gaglio. She outlined how the implementation of initiatives such as electronic submissions for regulatory approval can help to streamline processes.
During her talk, Gaglio explained how such strategies can help overcome some of the traditional barriers faced by the region: “Latin America was known for having regulatory complexity and a lot of bureaucracy with staggered and fragmented revisions and double reviews that lead to unpredictable timelines.”
Other challenges include poor connectivity and long distances between cities, where clinical trial sites are typically located, limiting the potential to recruit large and diverse populations. In addition, Gaglio commented that complex importation processes can restrict drug access, and this is now being improved with the introduction of preferential channels for clinical trial goods.
The LATAM region represents just 5.1% of the 4,669 Phase I-III clinical trials currently recruiting worldwide, compared to 23.1% in Europe, said Gaglio. Among the currently recruiting trials, the proportion of oncology studies is lower in countries such as Mexico, representing just 23%, versus in Asia and the US, where this number climbs to 61% and 50%, respectively.
Nonetheless, the cancer disease burden remains high due to disproportionate access to care, diagnostics and screening facilities across the region, and to a greater extent in low-income populations.
