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Regulatory Affairs

2026-03-14

18

min read

Mexico Is Becoming Latin America's Clinical Trial Powerhouse — While Colombia Falls Behind

COFEPRIS slashed approval times by 60%, launched a reliance pathway recognizing FDA and EMA decisions, and digitized its entire platform. Meanwhile, INVIMA's backlog hit 12,470 pending applications, approval times ballooned to 29 months, and Colombia's landmark clinical research bill was left without sponsors. A data-driven comparison of two countries heading in opposite directions.

By

Julio G. Martinez-Clark

A Tale of Two Regulators

In March 2025, Mexico's COFEPRIS published a landmark resolution in the Diario Oficial de la Federación establishing a "reliance" framework — allowing Mexico to recognize clinical trial approvals already granted by the FDA, EMA, MHRA, and Health Canada. By May 2025, COFEPRIS had cut clinical protocol approval times by 60%, from 90 days to 45 days. By the end of 2025, medical device registrations were being processed in 30 days.

Meanwhile, 2,000 miles to the south, Colombia's INVIMA was drowning. Approval times for new health product registrations had ballooned from 22 months in 2024 to 29 months in 2025. The agency had accumulated 12,470 pending applications. Between 2023 and 2025, INVIMA's budget was slashed by an average of 30%. And on March 9, 2026, the two congressional sponsors of Colombia's first-ever comprehensive clinical research law — Bill 191 — lost their re-election bids.

This is the story of two Latin American countries heading in opposite regulatory directions — and what it means for MedTech, biopharma, and radiopharma sponsors deciding where to invest their clinical research dollars.

**Why This Matters to You**

If you're a medical device or pharmaceutical company evaluating Latin America for clinical trials, regulatory registrations, or market access, the regulatory environment you enter today will determine your timeline, your costs, and your competitive position for years to come. The gap between Mexico and Colombia is widening — fast.

Mexico's Regulatory Revolution: How COFEPRIS Became Latin America's Most Reform-Minded Regulator

Under the leadership of Commissioner Armida Zúñiga Estrada, COFEPRIS has undergone what can only be described as a regulatory transformation. In less than two years, the agency has implemented a suite of reforms that collectively position Mexico as the most attractive clinical research destination in Latin America.

60% Faster Clinical Trial Approvals

The headline number: COFEPRIS reduced clinical protocol approval times from 90 days to 45 days between January and April 2025 — a 60% reduction. For protocol amendments, approval times dropped to 57 days, a 37% improvement over the statutory deadline.

Commissioner Zúñiga Estrada announced these results at both Researchland 2025 and the FIFARMA Annual Summit 2025, signaling that Mexico is not just reforming — it's marketing itself as a clinical research destination to the global pharmaceutical industry.

**By the Numbers: COFEPRIS Clinical Trial Reforms**

• • Clinical protocol approvals: 90 days → 45 days (60% reduction)
• • Protocol amendments: 57 days (37% improvement)
• • Medical device registrations: 30 days for reliance-eligible products
• • Historical backlog: 43% resolved in just 8 weeks
• • Digital platform (DIGIPRIS): 90% of amendments now processed digitally

The Reliance Pathway: Recognizing FDA and EMA Decisions

Published in the Diario Oficial de la Federación on March 24, 2025, COFEPRIS's reliance framework is arguably the single most important regulatory reform in Latin America in the past decade. Here's what it does:

• For clinical trials: COFEPRIS now recognizes Phase III clinical trial approvals already granted by the FDA, EMA, MHRA, Health Canada, and other WHO-recognized reference agencies. This eliminates duplicative reviews and allows sponsors to leverage existing approvals.
• For medical devices: Agencies participating in the International Medical Device Regulators Forum (IMDRF) and the Medical Device Single Audit Program (MDSAP) qualify as reference authorities. Decisions must be issued within 30 business days.
• For pharmaceuticals: FDA, EMA, WHO-listed authorities, and ICH founders are recognized as reference agencies. Decisions within 45 business days.
• The foreign authorization must be current — issued within five years prior to submission.

In practical terms, this means that if you have an FDA-cleared or CE-marked medical device, or an FDA-approved clinical trial protocol, Mexico can now process your application in 30–45 business days instead of the previous 90+ day timeline. This is a game-changer for sponsors who have already invested in FDA or EMA regulatory submissions.

**What 'Reliance' Actually Means**

Regulatory reliance does not mean COFEPRIS rubber-stamps foreign decisions. It means COFEPRIS leverages the scientific evaluation already performed by trusted international agencies to avoid duplicating work, while retaining the authority to impose additional national requirements. As Commissioner Zúñiga Estrada emphasized: "It's not about deregulating — it's about harmonizing. Regulation must keep pace with science without losing technical or bioethical rigor."

DIGIPRIS: Full Digitization of Regulatory Processes

COFEPRIS's digital transformation goes beyond faster timelines. The DIGIPRIS platform, developed in collaboration with Mexico's Agency for Digital Transformation and Telecommunications (ATDT), now handles 90% of all protocol amendments digitally. This eliminates the paper-based bottlenecks that plagued the previous system.

Starting in June 2025, COFEPRIS committed to publishing quarterly public reports with key performance indicators: application processing times, pending requests, response rates, and compliance levels from the regulated sector. This level of transparency is unprecedented among Latin American regulatory agencies.

Mexico's Ambition: Latin America's Clinical Trial Hub

These reforms are not happening in isolation. They are part of Plan México — the government's broader economic strategy to position the country as a nearshoring destination for global industries, including life sciences. COFEPRIS's modernization aligns with bilateral regulatory cooperation agreements with ANVISA (Brazil) and international harmonization efforts.

According to industry estimates, faster regulatory approvals can reduce time-to-market for new therapies by up to six months — with direct impact on patient access, therapeutic innovation, and national competitiveness.

The momentum extends beyond government action. On April 17, 2026, the V International Clinical Research Symposium for Central America — organized by ALCeic (Asociación Latinoamericana de Comités de Ética en Investigación Clínica) and APEIC — will take place at the Universidad Autónoma del Estado de México (UAEMex) in a hybrid format. The event, themed "Innovation as a Key Factor in Inter-Institutional Integration of Clinical Research Ecosystem Actors," brings together international experts to discuss innovation processes, regulatory frameworks, intellectual property in clinical trials, and the role of AI in clinical research.

The symposium's agenda features speakers from Mexico, Colombia, and Japan covering topics from the state of innovation in Mexico to AI-driven transformation in clinical research — underscoring Mexico's growing role as the intellectual and operational center of Latin American clinical research. That Mexico is hosting this pan-regional symposium, rather than any other country, is itself a signal of where the region's center of gravity is shifting.

Colombia's Regulatory Stagnation: A System Under Strain

While Mexico was reforming, Colombia was struggling. The data emerging from Afidro (the Association of Pharmaceutical Research and Development Laboratories in Colombia), Fifarma (the Latin American Pharmaceutical Industry Federation), and AmCham Colombia paints a stark picture of a regulatory system in crisis.

12,470 Pending Applications — and Counting

As of early 2026, INVIMA has 12,470 pending regulatory applications — a backlog that industry organizations attribute to institutional capacity loss and the absence of effective prioritization mechanisms. This isn't just a number. Each pending application represents a medical device, pharmaceutical product, or clinical trial that Colombian patients cannot access.

From 22 Months to 29 Months — In One Year

The average time for INVIMA to approve a new health product registration went from 22 months in 2024 to 29 months in 2025. This places Colombia among the slowest regulatory agencies in the region — a dramatic reversal for a country that was once considered one of eight Latin American agencies leading early access to innovative therapies.

To put this in perspective: while COFEPRIS is approving medical device registrations in 30 days, INVIMA is taking 29 months. That's not a gap — it's a chasm.

30% Budget Cuts to the Regulatory Agency

Between 2023 and 2025, INVIMA faced average budget cuts of 30%, directly impacting its operational capacity and ability to process regulatory applications. At the same time, the agency continues to operate under a regulatory framework that is nearly 70 years old — while other countries in the region have modernized their frameworks and adopted international guidelines.

Skyrocketing Denial Rates

Perhaps the most alarming data point: in 2025, 45% of new oncology molecule applications were denied by INVIMA. For orphan disease medications, the denial rate hit 50%. According to Afidro's data, 83% of the medications denied between 2017 and 2024 already had approval from the FDA or EMA.

Read that again: products already approved by the world's most rigorous regulatory agencies are being denied in Colombia at record rates. This isn't just a regulatory efficiency problem — it's a patient access crisis.

**The Human Cost**

Behind every denied application and every month of delay is a patient who cannot access a therapy that has already been deemed safe and effective by the FDA or EMA. Afidro's president, Ignacio Gaitán, stated that "Colombia was historically a reference in health regulation and one of the eight agencies that led early access to new molecules in Latin America." That leadership position is rapidly eroding.

Bill 191: Colombia's Lost Opportunity — And Why It Still Matters

Against this backdrop of regulatory stagnation, Colombia had one legislative lifeline: Law Bill 191 (Proyecto de Ley 191 de 2025 Cámara) — the first comprehensive clinical research law in the country's history. Filed on August 5, 2025, the bill aimed to establish a modern regulatory framework for the approval, execution, monitoring, and promotion of clinical research with human subjects in Colombia.

On March 9, 2026, Colombians went to the polls — and the bill's two sponsors, Senator Fabián Díaz (Alianza Verde) and Representative Juan Daniel Peñuela, were not re-elected. The bill, which had not yet received approval in its first debate, now faces automatic archival when the current constitutional period ends on July 20, 2026.

While the bill will need to be re-filed in the new Congress (2026–2030), the loss of momentum is significant. Colombia's clinical research community — represented by organizations like Avanzar (130 members spanning academia, pharma, CROs, and research centers) and ACIC (42 INVIMA-certified centers) — now faces the challenge of rebuilding support from scratch.

**Deep Dive: Bill 191 Analysis**

For a comprehensive analysis of what happened to Bill 191, the legal framework governing its fate, and the industry action plan for the new Congress, read our detailed report: What Happens to Colombia's Clinical Research Bill 191 After the March 2026 Elections?

También disponible en español: ¿Qué Pasa con el Proyecto de Ley 191 Después de las Elecciones de Marzo 2026?

The contrast is telling: while Mexico was implementing regulatory reforms through executive action — publishing resolutions, launching digital platforms, and setting performance targets — Colombia was trying to pass a law to begin the conversation about modernization. Mexico acted. Colombia debated. And the investment dollars are following the action.

Side-by-Side: Mexico vs. Colombia in 2025–2026

Metric

🇲🇽 Mexico (COFEPRIS)

🇨🇴 Colombia (INVIMA)

Clinical protocol approval

45 days (↓60%)

No published improvement

Medical device registration

30 days (reliance)

29 months average

FDA/EMA recognition

Yes — formal reliance pathway

83% of FDA/EMA-approved products denied (2017–2024)

Digitization

DIGIPRIS — 90% digital

InvimÁgil — in development

Transparency reporting

Quarterly public KPI reports

No public KPI reporting

Backlog management

43% cleared in 8 weeks

12,470 applications pending

Clinical research law

Existing framework + executive reforms

Bill 191 — sponsors lost election, facing archive

Oncology molecule denials

Not reported at comparable rates

45% denied (2025)

Orphan drug denials

50% denied (2025)

Government strategy

Plan México — active investment

No dedicated clinical research strategy

What This Means for Clinical Trial Sponsors and MedTech Companies

The divergence between Mexico and Colombia has immediate, practical implications for companies planning clinical programs or market entry in Latin America:

Mexico Is Now the Fastest Path to LATAM

If you have FDA or EMA clearance, Mexico's reliance pathway means you can have a clinical trial protocol approved or a medical device registered in 30–45 business days. For time-sensitive programs — breakthrough devices, first-in-human studies, or competitive market entry — Mexico has become the obvious first stop.

Colombia Remains Valuable — But Requires Patience and Local Expertise

Colombia's $3B+ medical device market, its treatment-naïve patient populations, and its emerging clinical research ecosystem still make it an attractive destination. But sponsors must factor in significantly longer regulatory timelines and work with a local partner who understands INVIMA's current operational reality. bioaccess® maintains a dedicated local entity in Colombia registered with INVIMA, providing legal representation, titleholder services, and technovigilance — all critical for navigating the current environment.

Multi-Country Strategies Are More Important Than Ever

The smartest sponsors aren't choosing between Mexico and Colombia — they're building multi-country strategies that start where approvals are fastest (Mexico, Chile) and expand into larger markets (Colombia, Brazil, Argentina) in parallel. This hedges risk and maximizes enrollment speed.

Can Colombia Catch Up? The Path Forward

Colombia is not without hope — but the window for action is narrow. Several initiatives are underway that could reverse the current trajectory:

• Regulatory reliance adoption: Afidro, Fifarma, and AmCham Colombia have formally proposed that INVIMA adopt a reliance mechanism similar to COFEPRIS's. Given that 83% of denied products already had FDA/EMA approval, this single reform could dramatically reduce the backlog and improve patient access.
• InvimÁgil digital platform: INVIMA is developing a digital platform to streamline applications, but it remains in early stages — far behind COFEPRIS's fully operational DIGIPRIS system.
• Ministry of Health decree: The Ministry of Health announced during Bill 191's public hearing that it is developing a decree to update Resolución 8430 de 1993 (the 30+ year-old regulation governing clinical research). This executive action could modernize the clinical trial framework without requiring congressional approval.
• Re-filing Bill 191 in the new Congress: The most important path forward. With Senator Norma Hurtado (re-elected, former rapporteur) as a natural champion, and the support of Avanzar, ACIC, and Afidro, a technically improved bill could be re-filed in the first weeks of the new constitutional period (July–August 2026).
• Budgetary strengthening: Any reform will fail without restoring INVIMA's operational capacity. The 30% budget cuts must be reversed.

**The Key Lesson from Mexico**

Mexico's success wasn't built on legislation — it was built on executive action. COFEPRIS published resolutions, launched platforms, and set performance targets without waiting for Congress. Colombia's Ministry of Health has the same power under existing law. The decree updating Resolución 8430 could be the single most impactful action Colombia takes — if it's ambitious enough and implemented quickly.

The bioaccess® Perspective: Operating in Both Markets

bioaccess® operates dedicated local entities in both Mexico and Colombia — registered with COFEPRIS and INVIMA respectively — providing registration holder services, legal representation, technovigilance, and distributor coordination. We have a front-row seat to the regulatory realities in both countries.

Our recommendation to clients hasn't changed: build a multi-country LATAM strategy. Mexico's reforms make it the ideal entry point for speed. Colombia's market size and patient populations make it essential for scale. Brazil remains the largest prize. And countries like Chile (fastest approvals) and Argentina (established infrastructure) round out a comprehensive regional approach.

But the sequencing has shifted. Where we once might have recommended Colombia as a first-entry market due to INVIMA's historically efficient processes, Mexico now leads the conversation. COFEPRIS's reliance pathway, combined with Mexico's $8B+ medical device market, USMCA trade advantages for US manufacturers, and the government's active promotion of clinical research, creates a compelling package.

At the same time, bioaccess® CEO Julio G. Martinez-Clark has been an active advocate for Bill 191 and the modernization of Colombia's regulatory framework. We believe in Colombia's potential — and we are committed to working alongside Avanzar, ACIC, and the broader coalition to ensure that Colombia gets the regulatory modernization its patients and its research community deserve.

**The Bottom Line**

Mexico is doing what Colombia is talking about doing. The reliance pathway, DIGIPRIS, the 60% reduction in approval times — these are implemented reforms with measurable results. Colombia still has the talent, the patients, and the market — but it needs to act with the same urgency. The clock is ticking, and the clinical research investment dollars are flowing to whichever country makes it easiest to get started.

Planning a Clinical Trial or Market Entry in Latin America?

Whether you're leveraging Mexico's new reliance pathway, navigating INVIMA's current environment, or building a multi-country strategy, bioaccess® can help you design, register, and execute across Latin America.

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