Clinical trials in Latin America face regulatory frameworks that vary by country. While countries like Argentina, Brazil, and Mexico have adopted international good clinical practice guidelines, regulatory approval processes can be lengthy, requiring documents translated to the local language and approvals from both local and national ethics boards. Common challenges include economic instability, intellectual property protection, and health care access and costs. Strategies for successful clinical trials in the region include early planning, partnering with experienced local clinical research organizations, and consulting regulatory experts from within each country.