Question 1

Which Latin American country has the fastest clinical trial approval timeline?

Accepted Answer

El Salvador currently offers the fastest combined ethics + regulatory approval in Latin America — as little as 30–45 calendar days under the 2025 parallel submission framework. Panama follows at 6–8 weeks. Colombia and Mexico typically run 8–14 weeks for straightforward FIH protocols.

Question 2

How long does a clinical trial take to get approved in Colombia?

Accepted Answer

Colombia’s INVIMA approves FIH protocols in approximately 8–12 weeks for standard medical device studies. Ethics committee (CCEIB) approval runs 4–6 weeks and can run in parallel. bioaccess® has completed 30+ FIH studies in Colombia and typically achieves first-patient-in within 6–9 months of protocol finalization.

Question 3

How long does Brazil’s ANVISA take to approve a clinical trial after the 2024 reform?

Accepted Answer

Brazil’s Law 14.874/2024 capped ANVISA review at 90 business days (down from 265 average) and CEP ethics review at 30 days. Total startup is now 6–12 months, down from 12–18+ months. The reform also enabled parallel ethics and regulatory submission.

Question 4

How does Latin America compare to the US and EU on trial startup timelines?

Accepted Answer

bioaccess® delivers a 12-month protocol-to-LPLV guarantee for standard FIH studies — 40% faster than equivalent US or EU pathways. US IRB review alone can take 6–12 months, and FDA IDE application adds further delay. Latin America’s streamlined ethics pathways make the overall timeline competitive even for complex protocols.

Question 5

Can I run trials in multiple Latin American countries simultaneously?

Accepted Answer

Yes. bioaccess® has executed multi-country FIH studies across Colombia, Panama, Mexico, and El Salvador simultaneously. Multi-country designs provide faster enrollment, geographic diversity (valuable for FDA submissions), and risk mitigation if one country faces regulatory delays.

Clinical Trial Approval Timelines by Country in Latin America