Global Clinical Research Accreditation Launches in Latin America IAOCR and GCSA have officially launched their gold-standard clinical research certification programs in Latin America through iaocramericas.com. For the first time, regional sites, professionals, and sponsors can access globally recognized accreditations to improve trial quality, reduce risk, and attract international partners. The initiative is backed by regional experts, including CRO bioaccess®, and aims to elevate Latin America's role in global clinical trials.
Read More
Mexico Introduces Fast-Track Approval Pathway for Phase III Clinical Trials via International Regulatory Reliance COFEPRIS has launched a new "Regulatory Reliance" pathway that will significantly accelerate approval timelines for Phase III clinical trials in Mexico—reducing review time to just 45 calendar days for studies already approved by the FDA, EMA, MHRA, or Health Canada. Effective 60 business days after its March 18, 2025 publication, this digital-only process positions Mexico as a competitive hub for international clinical research while maintaining strict safety and ethical oversight. The pathway is limited to non-adaptive Phase III trials in key therapeutic areas and excludes products with safety alerts. This regulatory innovation aligns with global trends and supports faster access to new therapies for patients in Mexico.
Read More