Global Trial Accelerators™

⚡ Beyond Approval: What’s Shaping Clinical Trial Execution in LATAM

**Colombia Clarifies Clinical Trial Protocol Submission with New Guide** [Source: INVIMA ASS-RSA-GU030] INVIMA released guidance ASS-RSA-GU030, standardizing how sponsors and CROs submit clinical research protocols involving human subjects in Colombia. The document details required materials, registration procedures on the Protocolos en Línea portal, and the sequence for ethical and administrative approvals, aiming to ensure consistency and participant safety. For companies planning first-in-human studies, the guidance simplifies navigation of local regulatory expectations and minimizes documentation errors. According to INVIMA, this framework is intended to reduce review timelines and raise protocol quality across submissions. *Strategic Takeaway: Adhering to the ASS-RSA-GU030 checklist may shorten regulatory cycles and reduce costly protocol rework in Colombia.* [Read More (INVIMA link)](https://www.invima.gov.co)

INVIMA Provides Guidance for Phase I–IV Clinical Trial Submissions

⚡ ANVISA Keeps Brazil's Clinical Research Pipeline Moving

ANVISA Clears Multiple Clinical Trial Modifications Across Global Sponsors

📈 Brazil's Clinical Research Momentum Continues to Build

**ANVISA Mandates Updated COVID-19 Vaccine Strain for 2024** [Source: ANVISA, 12th Ordinary Public Meeting Summary] Brazil’s ANVISA has announced a regulatory update aligning the required composition of COVID-19 vaccines with the WHO’s latest 2024 strain recommendations. The move applies to all new and existing COVID-19 vaccine dossiers seeking approval or renewal in Brazil, now requiring updated antigen specifications. The updated guidance streamlines protocol harmonization with EU and US standards, reducing duplication for sponsors operating in multiple jurisdictions. According to ANVISA, the change is expected to improve supply predictability for manufacturers and fast-track national vaccine assessment timelines. *Strategic Takeaway: Companies with adaptability in vaccine development pipelines may see accelerated access to Brazil’s COVID-19 market.* [Read More](https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/atualizacao-da-composicao-das-vacinas-contra-a-covid-19)

Key Points:

• All COVID-19 vaccines must comply with the newly specified 2024 strain composition.
• Updated protocol is expected to align Brazil with EU/US regulatory timelines for vaccine assessment.

Why It Matters: Faster regulatory alignment allows medtech companies to deploy updated COVID-19 vaccines in Brazil more efficiently, improving speed-to-market and resource allocation across geographies.

ANVISA Introduces Continuous Submission for Clinical Trial Dossiers

⚡ Faster Reviews, More Trials Across LATAM

**ANVISA Approves 12 New Drug Trial Authorizations, Streamlines Key Protocols** [Source: ANVISA, June 2026] ANVISA has authorized the initiation or continuation of clinical studies for 12 new investigational drugs in Brazil, including biosimilars and innovative therapies from companies such as **Pfizer**, **AstraZeneca**, and **Janssen** (ANVISA, RDC Resolution, June 2026). The approvals cover clinical trial protocol amendments, including product modifications and substantial procedural changes, benefiting 11 sponsors and CROs operating in the country. According to ANVISA filings, this update enables sponsors to adjust study protocols and investigational product characteristics without suspension of ongoing trials, supporting faster adaptation to new data and regulatory feedback. Many of the cleared drugs target oncology and autoimmune indications, underlining Brazil’s growing role in global clinical development. *Strategic Takeaway: Recent ANVISA actions highlight Brazil’s ability to support adaptive trial models and maintain regional competitiveness for early-phase drug and device trials.* [Read more]

Brazil Authorizes 12 New Clinical Investigations

⚡ LATAM's Clinical Research Reforms Move Into Practice

Brazil's Automatic Clinical Trial Approvals Become Reality

⚡ LATAM's Clinical Trial Reforms Move Into Execution

Mexico's 30-Day Clinical Trial Pathway Becomes Operational

🇨🇴 Colombia’s Clinical Research Future Enters a Critical Month

**Colombia's** presidential election results signal a potential regulatory shift that could impact medical device clinical trial operations across **Latin America**. Conservative candidate **Abelardo de la Espriella** leads with **44%** versus progressive **Iván Cepeda's 41%**, forcing a June runoff that will determine whether the region continues current healthcare policies or adopts more restrictive approaches.

Key Points:

• **De la Espriella** promises **10 mega-prisons** and security crackdowns similar to **El Salvador's** model, potentially affecting healthcare infrastructure priorities
• **Cepeda** plans to continue **President Petro's** progressive policies, including medical system improvements and "total peace" negotiations
• **Trump administration** pressure on **Latin American** countries to prioritize security could reshape regional healthcare spending patterns
• Election outcome may influence neighboring countries' regulatory approaches, particularly **Mexico** and **Ecuador** under **U.S.** diplomatic pressure

Why It Matters: A conservative victory in **Colombia** could trigger regional policy shifts that deprioritize healthcare innovation funding in favor of security spending, potentially affecting clinical trial site availability and regulatory timelines across **Latin America**.

Colombia’s Election Puts Clinical Research Policy in Play

⚡ LATAM’s Clinical Trial Race Accelerates

**COFEPRIS** shifts from sequential paper-based reviews to parallel digital processing for clinical trial approvals, Commissioner Rodrigo Bazúa announced at the First Clinical Research Summit. The regulatory agency identified significant backlogs dating to 2000, with duplicate submissions creating artificial delays when sponsors resubmit applications rather than respond to regulatory queries.

Key Points:

• Chemical and medical reviewers can now evaluate submissions simultaneously instead of sequentially
• Modular development allows registration modules to launch before licensing components are complete
• First-in-first-out processing system implemented to address accumulated application backlogs
• Review timeline inversely correlates with submission quality, according to **COFEPRIS** data

Why It Matters: Parallel review processes could materially reduce **Mexico's** clinical trial authorization timelines for medtech companies evaluating the market against **Brazil** and other regional alternatives.

Mexico Targets 30-Day Clinical Trial Reviews

🇧🇷 Brazil’s Clinical Trial Demand Surges as Costa Rica Enters the FIH Map

**ANVISA** published its 2025 organizational restructure, consolidating clinical trial oversight under a single coordination unit within the General Management of Biological Products. The new **Coordenação de Pesquisa Clínica em Medicamentos e Produtos Biológicos (Copec)** centralizes device trial authorizations previously handled across multiple departments.

Key Points:

• Clinical trial applications now route through **Copec** instead of fragmented departmental reviews
• Device trial timelines may compress further as regulatory bottlenecks between departments are eliminated
• **ANVISA's** organizational chart shows **Copec** reporting directly to **GGBIO**, streamlining decision authority

Why It Matters: Centralized oversight typically reduces regulatory friction and creates more predictable approval pathways for medtech sponsors planning **FIH** studies in **Brazil**.

Brazil’s clinical trial ambitions meet a capacity test

🌎 Why Smaller LATAM Markets Are Winning More FIH Trials

Ophthalmic device companies targeting first-in-human studies in Latin America consistently achieve faster enrollment in smaller markets like **El Salvador**, **Panama**, and the **Dominican Republic** compared to regional giants **Brazil** and **Mexico**. **bioaccess®** operational data shows **6-10 week** timelines from contract signature to first patient screened in smaller markets versus **12-16 weeks** in larger countries for early-stage studies.

Key Points:

• Ethics committees in smaller markets review 3-6 device protocols quarterly versus 30-60 in major metropolitan centers, reducing approval bottlenecks
• Principal investigators provide concentrated attention across 5-10 patient FIH cohorts without competing trial obligations
• Single-country FIH programs in smaller markets reduce cash burn during capital-constrained early development phases
• **FDA** accepts FIH data from any country under **21 CFR 812.28** provided **ICH-GCP** compliance standards are met

Why It Matters: Smaller markets deliver **50% faster** FIH completion timelines, allowing ophthalmic device startups to generate safety data and advance to pivotal trials before depleting Series A capital reserves.

Smaller LATAM Markets Gain Momentum for FIH Studies