Uneven Clinical Trials

LATAM has no central regulator: review times run from 70 business days at Argentina’s ANMAT to 18–24 months at Brazil’s ANVISA. Choose a route early, global-first, parallel jurisdiction, or reliance.

The rationale

LATAM has no centralized agency overseeing trial phases or market readiness, so every country is its own project. As reported in 2025: Argentina’s ANMAT clears in 70 business days or fewer, down from roughly 160 since 2017; Chile’s ISP takes 6 to 8 months; Colombia’s INVIMA 12 to 18 months; Brazil’s ANVISA historically 18 to 24 months; Mexico’s COFEPRIS is officially 5 to 60 days on the equivalence route, yet backlogs push real approvals to one or two years. Each is a live regulatory fact and each has probably moved since the interviews. A venture compliant in one country is not a regional venture, and investors price the difference.

The report sets out three non-exclusive routes. Global-first alignment means building to FDA or EMA-grade standards from the first protocol, which de-risks export and capital access; that is a founder decision available this year and needs no institutional reform. Parallel jurisdictions, special economic zones with bespoke regulatory pathways, compress permit cycles, and the region already runs large ones with real economic records in Costa Rica, the Dominican Republic and Uruguay. Regional interoperability means reliance: mutual recognition of selected scientific approvals, built on machinery that already exists in health, the Pan American regulatory network and the single-audit program for medical devices.

Two objections deserve a straight answer. Stakeholders cautioned that an FDA-only posture can backfire, slowing iteration velocity, entrenching incumbent advantages and loading prohibitive compliance costs onto pre-revenue teams, so global-first belongs where the export path pays for it and not as a reflex. And the biomedical SEZ case the report examines, Próspera in Honduras, is contested by bioethicists, challenged as illegal by Honduran authorities, and in litigation as the state moves to unwind the framework. Its self-reported speed claims cannot be verified and are not used here.

The evidence

First moves

1. 0–6 months

   Publish a dated five-country regulatory clock

   Compile review times, dossier requirements and foreign-data acceptance rules for ANVISA, COFEPRIS, INVIMA, ISP and ANMAT, each entry stamped with the date it was last checked with the agency, and refresh it quarterly.

   LADP coalition secretariat + national regulatory affairs associations
2. 6–18 months

   Run a reliance pilot on one product class

   Pick one low-risk class, in-vitro diagnostics is the obvious candidate, and get two agencies to accept each other’s dossier review under a written reliance protocol with a defined re-review and appeal route.

   National regulators (ANVISA, ISP, INVIMA) + PAHO
3. 18–36 months

   Extend single-audit recognition beyond devices

   Use the medical-device single-audit model as the template for a second product class, and map in-zone conformity assessment in existing free zones to US, EU and ISO standards so results travel outside the zone.

   Mercosur and Pacific Alliance secretariats + free-zone authorities (CINDE, CNZFE, Uruguay XXI)

How we would know it worked

• Median days from dossier submission to decision at each of the five agencies, published quarterly in the regulatory clock, with the spread between fastest and slowest narrowing.
• Product classes covered by a signed reliance or mutual-recognition protocol between two or more LATAM regulators, rising from zero.
• Approvals granted on the basis of another agency’s review, reported annually by each participating regulator.
• Share of LATAM biotech ventures closing a Series A that hold an FDA or EMA-grade dossier at the time of the round, tracked through the funders registry.

What could go wrong

Who acts

Rests on

The data behind it