Uneven Clinical Trials: Alignment Through Interoperability
Recommendation 07 · Investor Readiness
LATAM does not have a centralized regulatory agency overseeing trial phases and market readiness for emerging biotech or AgTech innovations. Each country operates under its own rules and timelines, making navigation both challenging and essential for success.
As detailed by Cristián Hernández, Zentynel’s General Partner, a drug approval in Chile can take 6 to 8 months, in contrast to the 1.5 to 2 years it may take the Brazilian, Mexican or Colombian equivalents. Below is an overview of the regulatory framework different countries maintain for biotech.
| Country · Agency | Review time | Notes |
|---|---|---|
| Brazil · ANVISA | 18–24 months historically | Reforms aim for 120–365 days for innovative therapies, but separate GMP certification can add months. |
| Mexico · COFEPRIS | 5–60 days (equivalence route) | Officially fast, yet backlogs often extend approvals to 1–2 years, prompting some firms to seek legal remedies. |
| Colombia · INVIMA | 12–18 months | Flexible use of foreign data and SME incentives ease entry for companies with US/EU dossiers. |
| Chile · ISP | 6–8 months, predictable | Smaller market but a transparent, strategic first stop for biologics, diagnostics, and precision medicine. |
| Argentina · ANMAT | ≤70 business days (from ~160 since 2017) | Incomplete documentation can still cause delays. |
For international investors, this augments the risk of investing, as it may not be strategic to back an early-stage startup that only complies with regulations of a single country, thus impeding regional and global expansion.
# Recommendations: Global-First Alignment Through Interoperability
To bypass this hurdle, regional investors have been encouraging portfolio startups to work with a global-first approach from the beginning, like the FDA or EMA, to immediately meet international standards. By aligning with FDA frameworks, companies signal adherence to rigorous standards, reducing perceived risks and facilitating smoother market entry.
However, stakeholders cautioned that an FDA-only posture can backfire, slowing iteration velocity, entrenching incumbent advantages, and imposing prohibitive compliance costs on early-stage ventures. Another model worth exploring is Próspera in Honduras, a Special Economic Zone offering bespoke regulatory pathways for health and biotech. Próspera self-reports "15× faster commercialization of drugs" and markets its health regime as enabling companies to go "10–100× faster." Under this framework, the gene-therapy startup Minicircle has conducted Phase I human trials.
That said, the model is contested, by bioethicists and biotech operators concerned about oversight, by Honduran authorities challenging Próspera’s legality, and by local communities. The zone is embroiled in legal disputes with the state amid efforts to unwind the SEZ framework. These tensions underscore both the potential speed advantages and the governance risks of using special-jurisdiction routes for biomedical development.