Argentina just reshaped its clinical trial approval process — and the implications for early-phase sponsors are significant.
first-in-human · FIH · clinical trial · regulatory · ANMAT · FDA
Argentina just reshaped its clinical trial approval process — and the implications for early-phase sponsors are significant. Meanwhile, choosing the right LATAM country for your FIH trial just got more nuanced.
• Understand Argentina’s new 62-day approval timeline and what it means for your program.
• Compare Panama, Colombia, and Chile for your first-in-human trial.
• Track breakthrough FIH milestones in neurostimulation and RNA therapies.
• See where multispecific T-cell engagers are heading in oncology.
Stay ahead by aligning strategy with execution from day one.
Argentina now has a legally binding maximum clinical trial approval timeline of 62 days. Under ANMAT Disposición 7516/2025 — in full effect since December 1, 2025 — the approval process has been fundamentally restructured. Ethics review can now run in parallel to regulatory review, risk-stratified tracks create faster paths for low-complexity studies, and Argentina has formally adopted ICH E6(R3) Good Clinical Practice standards.
For MedTech and biopharma sponsors evaluating where to run first-in-human or early-phase clinical programs in Latin America, this is a material change in the regulatory landscape.
What to Focus On: Argentina’s new framework rewards sponsors who engage early with both ANMAT and ethics committees simultaneously. Parallel processing is the key advantage — use it.
Choosing the right location for a first-in-human trial in Latin America is one of the most consequential early decisions a sponsor can make. Panama, Colombia, and Chile each offer distinct advantages — and trade-offs — depending on your study design, therapeutic area, and timeline.
Key considerations:
• Panama offers streamlined regulatory pathways and competitive timelines for device studies
• Colombia combines strong clinical infrastructure with growing investigator networks
• Chile provides regulatory rigor and a well-established ethics review process
Practical Insight: There is no single best country. The right choice depends on your trial’s complexity, patient population, and regulatory strategy. Early planning and local expertise are what separate efficient execution from costly delays.
Does your company need accelerated first-in-human clinical trial results?
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• Leverage 20+ years of expertise across Medtech, Biopharma, and Radiopharma first-in-human trials
• Navigate Latin America’s regulatory environment and access high-quality research sites
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Nia Therapeutics’ Smart Neurostimulation System (SNS) is the first device to obtain FDA breakthrough designation for memory loss related to moderate-to-severe traumatic brain injury (TBI). The device is now moving into first-in-human clinical trials.
This milestone underscores the growing momentum in neuromodulation and the FDA’s willingness to fast-track devices addressing significant unmet medical needs.
Why It Matters: Breakthrough designation signals strong regulatory support and can accelerate the path to market. For medtech sponsors developing novel neurostimulation technologies, this is a validation of the FIH-first strategy.
A next-generation GLP-1 therapy using circular RNA technology has completed its first-in-human trial, marking a significant step forward for sustained diabetes treatment. Circular RNA offers improved stability and prolonged protein expression compared to traditional mRNA approaches.
This represents a new modality entering clinical validation — one that could reshape how metabolic diseases are treated at the molecular level.
Why It Matters: As new modalities like circular RNA reach FIH milestones, sponsors and CROs need to prepare for increasingly complex early-phase trial designs that demand specialized expertise
Multispecific T-cell engagers are emerging as a promising next-generation approach in both oncology and autoimmune disease. These engineered molecules can simultaneously target multiple antigens, offering the potential for more precise and effective immune responses.
The growing pipeline of multispecific engagers reflects a broader industry shift toward more complex biologics — therapies that demand sophisticated clinical trial design and execution from the earliest stages of development.
Why It Matters: As these therapies move into early-phase trials, sponsors will need CRO partners with deep expertise in complex biologics and multi-arm study designs.
In the latest episode of the Global Trial Accelerators™ podcast, bioaccess® CEO Julio G. Martinez-Clark is joined by a leading expert to discuss how medical device companies can rethink their clinical strategy from the ground up.
Key themes include aligning regulatory pathways with clinical evidence generation, optimizing study design for efficiency, and building a development strategy that accelerates time to market without compromising data quality.
Listen now at globaltrialaccelerators.com
• Argentina’s 62-day clinical trial approval framework is now in effect — a major shift for LATAM sponsors
• Panama, Colombia, and Chile each offer distinct FIH trial advantages depending on study design
• Nia Therapeutics’ neurostimulation device is the first to receive FDA breakthrough designation for TBI memory loss
• Circular RNA technology has reached its first-in-human milestone for sustained diabetes treatment
• Multispecific T-cell engagers are gaining pipeline momentum across oncology and autoimmune diseases
• Rethinking clinical strategy early can compress timelines and improve regulatory outcomes
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