Clinical Trial Approval Times in Latin America, the US and Canada: Legal Clocks vs Real-World Data (2026)

Legal review clocks and real-world approval times for clinical trial regulators in Latin America, the US and Canada, with an official source for each country, drug and device differences, a checklist and FAQ.

By Julio G. Martinez-Clark

CEO, bioaccess®

General information, not legal or regulatory advice. Legal deadlines are cited to the regulation or the regulator’s own page. Figures marked “bioaccess® experience” come from the study timelines (Gantt charts) we have prepared for sponsors; they are planning estimates, not legal deadlines or guaranteed turnarounds. Rules change, so confirm the current clock with the regulator before you commit a date.

In this guide: The short answer · How to read a review clock · Clocks at a glance · Country table · Legal vs observed · Drugs vs devices · Planning checklist · Glossary · FAQ · Sources

The short answer

Most regulators in the Americas publish a review clock for clinical trials. For the main drug and device authorization routes in 2026, the published clocks run from 30 calendar days (United States, Canada, Mexico) to 90 business days, about 4 months (Brazil, drug trials). Some steps have shorter clocks, such as acknowledgments, registrations and fast-track targets. Uruguay’s health ministry publishes no regulator clock in the sources we checked.

A legal clock is not your approval date. Five things decide how long the review really takes:

When the clock starts. Most clocks start only when the file is accepted as complete.
Whether it stops. In most countries the clock stops while you answer the regulator’s questions.
What silence means. In the United States, Canada (drug trials) and Brazil, a trial can start if the regulator does not object within its clock. In Mexico, silence means the application is denied.
The order of reviews. In Mexico, Colombia, Peru, Chile, Costa Rica, Ecuador and Guatemala the regulator reviews after the ethics committee approves. In Argentina, ANMAT authorizes the study and each site follows with its committee’s approval. In Brazil, and in Panama for high-risk research, the two reviews can run at the same time. In El Salvador one submission goes to both through a shared platform, and the regulator’s authorization requires the ethics approval.
Business days or calendar days. 30 business days is about 6 weeks; 90 business days is about 4 months, before public holidays.

Real-world data can sit on either side of the clock. Mexico’s regulator, COFEPRIS, reported an average of 45 days to approve protocols in January–April 2025, against the 90-day legal term then in force; the 30-calendar-day maximum came in with the April 2025 agreement. Brazil’s regulator, ANVISA, reported that 23% of the trial petitions it closed in 2025 were released because its 90-business-day clock ran out.

This guide applies to drug and device trials. Where the rule differs for devices, the table says so. For the full path from protocol to first patient, see our site activation timeline guide.

How to read a review clock

The steps are industry standard across the Americas: the sponsor files, the regulator checks the file is complete, the technical review runs, the regulator asks questions or decides, and the sponsor answers. Each country sets its own rules for five points.

Question to ask	Why it matters	Example
Business or calendar days?	60 business days is about 3 months; 60 calendar days is 2.	Colombia’s INVIMA counts business days; Mexico’s 2025 maximum is in calendar days.
What starts the clock?	A completeness check can come first.	Guatemala validates the file within 5 calendar days; its 30-business-day clock runs from complete documentation.
Does the clock stop for questions?	Your answer time is usually not counted.	Panama’s ethics committees do not count the time spent answering them. Brazil’s single technical requirement suspends ANVISA’s clock.
What happens if the regulator is silent?	Decides whether a late review blocks you.	Brazil: start with ethics approval. Mexico: deemed denied. Peru: the sponsor can appeal.
Ethics first, or at the same time?	Sequential reviews add the ethics time to the regulator’s clock.	Mexico’s committees approve before COFEPRIS reviews; in Panama, MINSA’s review of high-risk research runs alongside the ethics review.

Clocks at a glance

Published regulator clocks vs observed times (sources in the table below)

The bars show each regulator’s published clock for a first decision, converted to approximate calendar days (business days × 7/5, before holidays). The dots show published real-world averages and, separately, bioaccess® experience. Ethics review time is not included unless the label says so. Uruguay’s health ministry publishes no regulator clock, so it has no bar.

Regulator review clocks by country

Country	Regulator	Published clock	Clock stops and silence	Ethics order	Drugs and devices	Official source
Argentina	ANMAT	Clinical pharmacology (drug) studies for registration purposes: 20 business days technical review + 10 administrative for low-risk and special studies; 35 + 10 for the rest. Completeness is checked within 2 business days. Phase 1, advanced-therapy, innovative and locally developed products need a pre-submission meeting, requested at least 60 business days before filing.	ANMAT stops the clock when it raises objections; the sponsor has 15 business days to answer, or the application can be denied. No silence rule found.	ANMAT authorizes the study; each site is then authorized by, or notified to, ANMAT with the approval of its accredited ethics committee.	The 2025 rule covers clinical pharmacology studies. Device trials follow a separate ANMAT procedure: confirm the clock.	Disposition 7516/2025
Brazil	ANVISA	Drugs: 90 business days for the clinical drug development dossier. Prioritized drug petitions: 60 calendar days in total since January 2026 (15 days to confirm priority, then 45, under RDC 1.001/2025); rare-disease trials: 30 calendar days once ANVISA confirms the priority (RDC 205/2017). Devices (class III–IV not registered in Brazil, or a new indication): 90 calendar days.	Drug trials (RDC 945): one technical requirement suspends the clock, and the sponsor has 30 business days to answer. Drugs and devices: if ANVISA does not answer in time, the trial can start once the ethics approval is in.	Can be filed at the same time as ethics; the trial starts only after both approve.	Class I–II device studies, and registered devices studied for their approved indication, do not file a device dossier with ANVISA.	Law 14,874/2024; RDC 837/2023
Chile	ISP	Drug trials: a 45-day term for evaluation and authorization, as InvestChile reported it in 2022; ISP’s reported average evaluation was 28 business days. The center director then authorizes the study.	Ethics committee: 45 days for its report, extendable once by 20 days.	The accredited ethics committee reports first; the file then goes to ISP.	bioaccess® experience (device study): a notification to the health authority after ethics approval, acknowledged in about 16 days.	Supreme Decree 114/2010; Resolution 5161; InvestChile
Colombia	INVIMA	Drug trials: first response within 60 business days.	The sponsor has 30 days to answer or request an extension; INVIMA decides within 30 days of the answer. No silence rule found.	Ethics committee first.	Device trials go to INVIMA’s specialized devices chamber. We found no published device clock.	INVIMA guide ASS-RSA-GU039; device trials page
Costa Rica	CONIS (national research council)	Acknowledgment of a complete registration within 5 business days, which registers the protocol provisionally; technical report within 10 business days of assignment.	A single notice to complete the file, with 10 business days to respond.	Accredited ethics committee (CEC) first; the CEC files with CONIS.	Applies to biomedical research generally. At social security (CCSS) hospitals, research can start 8 days after the investigator is notified of the CONIS registration and receives the ethics approval documents (CCSS instruction).	CONIS procedure 2025
Dominican Republic	CONABIOS (national bioethics council)	Final result within 45 business days; 21 calendar days for urgent protocols. Submit at least 60 days before the planned start.	No silence rule found.	The site’s ethics committee (or a recognized independent one) approves first; CONABIOS then gives the national ethics review. Confirm whether a separate regulator review applies to your study.	Applies to research protocols generally.	CONABIOS manual, 2nd ed.; legal basis, incl. Provision 004-A-2004
Ecuador	ARCSA	As published by ARCSA (day type not stated): document check in 7 days; technical review up to 60 days, extendable by 30.	Document observations: 30 days to correct, extendable by 30. Technical observations: 90 days to answer, extendable by 90. No silence rule found.	The ethics committee (CEISH) approves first; its approval is part of the ARCSA file.	Device trials follow the drug procedure until device rules are issued. A sponsor without a seat in Ecuador designates a contract research organization registered with ARCSA.	ARCSA clinical trial authorization
El Salvador	SRS clinical trials unit (UEC)	The SRS published route (2025): research site registration 20 business days; ethics approval by the national committee (CNEIS) 20 business days; trial authorization by the UEC 20 business days; special import permit 24 to 72 business hours; product check at the site 14 business days.	No silence rule found.	One shared SRS–CNEIS platform receives the ethics and the technical files. The SRS route lists CNEIS approval before the UEC authorization, and the authorization file includes the ethics approval.	The SRS guide covers drugs and devices. bioaccess® experience (study timelines): approval in about 47 days without questions; 67 to 85 days with one round.	SRS evaluation route; SRS authorization guide, 2025
Guatemala	DRCPFA (Ministry of Health)	File validated within 5 calendar days; authorization within 30 business days of complete documentation.	The sponsor has 15 business days to answer; final decision within 15 business days of the answer.	A favorable report from an authorized ethics committee is part of the file.	Covers drugs and devices.	Ministerial Agreement 206-2021
Mexico	COFEPRIS	Maximum 30 calendar days for protocol authorization, including the reliance route, under the April 2025 agreement.	COFEPRIS issues one prevention notice, answered in a single upload within the deadline it sets. If COFEPRIS does not respond, the application is deemed denied (ClinRegs).	The ethics committee’s approval is part of the application, so the committees approve first.	One procedure (COFEPRIS-04-010) covers drugs and devices (‘new resources’). Since May 2026, research without risk no longer needs COFEPRIS authorization. The approved consent and the insurance policy can be filed with the application or within 15 business days after authorization.	DOF, 28 April 2025; DOF, 4 May 2026; ClinRegs Mexico
Panama	MINSA and the pharmacy directorate (DNFD)	Registry receipt within 3 business days. Where medicines or health products are used, the DNFD responds within 15 business days. Ethics review up to 20 business days (10 expedited), 30 in total if it goes to the full committee.	Ethics review: the time spent answering the committee is not counted. MINSA’s technical review of high-risk research has no published clock, and its result must be answered before the committee’s final decision.	For high-risk research, MINSA’s technical review runs alongside the ethics review.	Medicines and other health products.	Executive Decree 21/2026
Peru	INS	Maximum 30 working days, including the 30-day opinion of the medicines authority (DIGEMID).	If INS misses the deadline, the sponsor can file an appeal within 15 business days.	The INS-accredited ethics committee approves first.	Confirm the scope for device studies with INS.	Supreme Decree 021-2017-SA (MINSA); ClinRegs Peru, also citing Supreme Decree 010-2025-SA
Uruguay	MSP (Ministry of Public Health)	No MSP clock found. National ethics commission (CNEI): 60 days, extendable, for trials with new drugs, indications, vaccines, diagnostics, devices or invasive procedures.	The CNEI clock runs from complete documentation. Investigators have 60 days to answer committee questions, or the file is archived.	The institutional ethics committee (60 days) and, where required, the CNEI review before MSP registration and authorization.	Drugs and devices both go to the CNEI.	Decree 158/019
United States	FDA	Drugs: an IND goes into effect 30 days after FDA receives it. Devices (significant risk): an IDE study can begin 30 days after receipt.	If FDA does not place a clinical hold (IND) or object (IDE) within 30 days, the study can begin with IRB approval.	IRB review can run at the same time; no federal IRB clock.	Non-significant-risk device studies need no IDE application to FDA; IRB approval and the abbreviated IDE requirements apply.	21 CFR 312.40; 21 CFR 812.30; 21 CFR 812.2
Canada	Health Canada	Drugs: 30-day default for a clinical trial application (CTA); 7-day administrative target for phase I trials in healthy adults and comparative bioavailability studies. Devices (class II–IV): 30-day review target for an investigational testing authorization (ITA).	CTA: the trial can proceed after 30 days without an objection. ITA: a target, not a default; a request for information gives 60 days to respond, then a new 30-day review.	Research ethics board (REB) approval is required for each site; it can run at the same time.	The 7-day target excludes cell and gene therapies, xenografts, prophylactic vaccines and reproductive technologies.	CTA guidance; ITA guidance

Colombia note. INVIMA reviews after the ethics committee approves, so plan the committee calendar first. bioaccess® runs first-in-human studies in Colombia now.

What the clock does not include. Import permits, insurance, contracts and translation run outside the regulator’s clock. Mexico’s import permit for investigational drugs has its own 10-day clock, and approval is deemed granted if COFEPRIS does not answer (ClinRegs). See what slows site activation and our insurance requirements by country.

Ethics committee clocks are covered country by country in our ethics committee submission requirements guide.

Legal clocks vs observed times

Published data on real review times is scarce. Here is what we found, with each source’s scope. Most figures measure the regulator only, not ethics or the whole start-up.

Country	Observed time	Scope	Source
Brazil	Petitions filed under Law 14,874 and closed in 2025, mean total time to completion: prioritized, 72 to 78 days (reliance route) and 119 to 187 days (full review); non-prioritized, 126 days (reliance), 157 days (full review) and 136 days (released when the clock ran out).	ANVISA drug trial petitions; completion includes approvals, refusals and withdrawals; total = queue + analysis + sponsor time	ANVISA COPEC annual report 2025
Brazil	23% (93) of trial petitions closed in 2025 were released because the 90-business-day clock ran out.	ANVISA drug trial petitions	ANVISA COPEC annual report 2025
Brazil	Only 12.5% of trials enrolled their first participant within 60 days of ANVISA authorization; 31% took more than 180 days.	264 trials started	ANVISA COPEC annual report 2025
Brazil	Mean final approval fell from 341 days (2013) to 90 days (2023) at ANVISA, and from 164 to 141 days at the national ethics commission (CONEP).	196 oncology trials managed by contract research organizations, before Law 14,874	Giacomazzi et al., JCO Global Oncology, 2026
Mexico	Average 45 days in January–April 2025 (50 calendar days in the first quarter), down from 90 in 2024; amendments 57 days.	COFEPRIS protocol approvals, before the 30-day maximum took effect	COFEPRIS press release 16/2025
Argentina	Average approval about 80 days, down from 140 in 2018.	ANMAT, as reported by the pharmaceutical chamber CAEME, before Disposition 7516/2025	Economis, 2022
Chile	Average evaluation 28 business days for authorization to import, manufacture or use an investigational drug.	ISP drug trial authorizations, as reported by InvestChile (2022)	InvestChile
Panama	Registry number about 5 days after filing; MINSA review about 26 days; first ethics response about 28 days.	bioaccess® experience, from our study timelines	bioaccess® study timelines
El Salvador	First responses in about 3.5 to 7 weeks; approval in about 47 days without questions, 67 to 85 days with one round.	bioaccess® experience, from our study timelines; regulator and ethics together	bioaccess® study timelines
Colombia	Each site’s ethics approval in about 4 to 5 weeks, then INVIMA.	bioaccess® experience, from our study timelines (device study)	bioaccess® study timelines

What the data shows. Review times have shortened across the region. Mexico, Brazil and Argentina all report real times well below where they were a few years ago. But a legal clock does not guarantee your authorization date or your first patient: in Brazil, almost a quarter of petitions ran past the 90-business-day clock in 2025, and the time from authorization to first participant was often longer than the review itself.

For context only: a 2026 review reported median trial start-up times of about 2.8 months in Mexico, 4.5 months in Argentina, 4 to 7 months in Brazil, 4.6 months in Chile, 7 months in Colombia and up to 9 months in Peru (Zavaleta-Monestel et al., Cureus, 2026). Start-up definitions differ between studies, so these are not comparable with the review clocks above.

Drugs vs devices

The steps are the same for drugs and devices: ethics review, regulator review where it applies, then import and site activation. The differences are in scope and clocks:

Some device studies skip the regulator. In the United States, non-significant-risk device studies need IRB approval only. In Brazil, only class III–IV devices not registered in Brazil (or used for a new indication) file a device dossier with ANVISA.
Device clocks can differ. Brazil’s device clock is 90 calendar days, shorter than the 90 business days for drugs. Canada’s device review (ITA) has a 30-day target, not a default approval.
Some rules are drug-only. Argentina’s 2025 disposition, Colombia’s GU039 clock and Chile’s ISP authorization are written for drug trials. Ask the regulator which procedure and clock apply to your device.
Same procedure in some countries. Mexico, Ecuador, Guatemala and El Salvador use one procedure for drugs and devices.
Brazil’s drug-only clock stop. The single technical requirement and 30-business-day answer period are set for drug dossiers; ask ANVISA how questions are handled for a device dossier.

Planning checklist: before you trust a review date

☐ Confirm whether the clock is in business or calendar days, and list the public holidays in the window.
☐ Find what starts the clock: filing, acceptance as complete, or payment of the fee.
☐ Check whether ethics approval must come first. If so, add the committee’s time and meeting calendar.
☐ Plan at least one round of questions and your answer time, which is usually not counted.
☐ Read the silence rule. Know whether a late answer lets you start, blocks you or lets you appeal.
☐ For devices, confirm the class and whether the study needs regulator review at all.
☐ Check post-approval filings, such as Mexico’s consent and insurance filing within 15 business days.
☐ Plan the import permit, insurance and contracts in parallel; they are outside the clock.
☐ Compare the legal clock with published observed data before you set a date.
☐ Re-check the rules: Panama (2026), Argentina (2025), Mexico (2025) and Brazil (2024) changed their procedures recently.

Glossary

Business day (día hábil). A working day, excluding weekends and public holidays.
Clock stop. A pause in the review clock while the sponsor answers questions.
Silence rule. What happens if the regulator does not answer within its clock: the trial can start, the application is denied, or the sponsor can appeal.
CTA / IND. Clinical trial application (Canada) and investigational new drug application (United States).
ITA / IDE. Investigational testing authorization (Canada) and investigational device exemption (United States), the device equivalents.
Reliance route. A shorter review that relies on an approval by a reference regulator.
Ethics committee (CEI, CEP, CIEI, CEC, CEISH, IRB, REB). The local names for the committee that reviews a study’s ethics and consent.
DDCM. Brazil’s clinical drug development dossier filed with ANVISA.

Frequently asked questions

How long does clinical trial approval take in Latin America?
Published regulator clocks for a first decision run from 30 calendar days in Mexico to 90 business days, about 4 months, for drug trials in Brazil. Add the ethics review where it must come first, and the time to answer questions. Published averages were 45 days at COFEPRIS (Mexico) in early 2025, and about 2.4 to 6 months to complete ANVISA petitions (Brazil) in 2025, depending on the route.

Which country in Latin America has the fastest regulatory approval?
Compare like with like: the whole path to permission to start, not one step. On that basis, Panama’s published clocks are short (DNFD 15 business days; ethics up to 20 business days, 30 if the study returns to the full committee), and Mexico’s regulator has 30 calendar days after the committees approve. In our study timelines, Panama and El Salvador approved complete submissions in about 1 to 3 months, ethics included. The fastest country for your study also depends on where your patients are.

Can ethics and regulatory reviews run at the same time?
In Brazil, and in Panama for high-risk research, yes. El Salvador takes one submission for both through a shared platform, and the authorization requires the ethics approval. In Mexico, Colombia, Peru, Chile, Costa Rica, Ecuador and Guatemala, the ethics committee approves first. In the United States and Canada, IRB or REB review can run alongside FDA or Health Canada review.

What happens if the regulator does not answer in time?
It depends on the country. In the United States, Canada (drug trials) and Brazil, the trial can start once ethics approval is in. In Mexico, the application is deemed denied. In Peru, the sponsor can file an appeal within 15 business days. Most other countries publish no silence rule.

How long does COFEPRIS take to approve a clinical trial?
Since the April 2025 agreement, COFEPRIS has a maximum of 30 calendar days for protocol authorization, after the ethics committee approves. Before that agreement the legal term was 90 days, and COFEPRIS reported an average of 45 days in January–April 2025.

How long does ANVISA take to approve a clinical trial?
ANVISA has 90 business days for standard drug trial dossiers, 60 calendar days in total for prioritized petitions since January 2026, 30 calendar days for confirmed rare-disease trials, and 90 calendar days for dossiers on class III–IV devices not registered in Brazil (or a new indication). If it misses the deadline, the trial can start with ethics approval; 23% of petitions closed in 2025 were released this way.

How long does INVIMA take to approve a clinical trial?
For drug trials, INVIMA gives its first response within 60 business days, after ethics approval. The sponsor has 30 days to answer and INVIMA decides within 30 days. We found no published clock for device trials.

Do device trials have the same approval times as drug trials?
Not always. Brazil’s device clock is 90 calendar days, and non-significant-risk device studies in the United States need no IDE application to FDA. Argentina’s, Colombia’s and Chile’s published clocks are for drug trials. Mexico, Ecuador, Guatemala and El Salvador use one procedure for both.

Is the regulator’s approval enough to start the trial?
No. You also need ethics approval, a signed site contract, insurance, the product on site and a trained team. In Brazil, only 12.5% of trials enrolled their first participant within 60 days of ANVISA authorization.

Plan your approval timeline

bioaccess® prepares country-by-country approval timelines for drug and device sponsors, using the published clocks and our own study timelines. bioaccess® runs first-in-human studies in Colombia now. Contact us to get a timeline for your study.

Sources

Argentina: ANMAT Disposition 7516/2025 (InfoLEG).
Brazil: Law 14,874/2024 (Planalto); ANVISA RDC 945/2024 and RDC 837/2023; ANVISA COPEC annual activity report 2025; Giacomazzi et al., JCO Global Oncology, 2026.
Chile: Supreme Decree 114/2010 and ISP Exempt Resolution 5161 (Ley Chile); InvestChile pharmaceutical industry e-book.
Colombia: INVIMA guide ASS-RSA-GU039; INVIMA medical device clinical investigation page.
Costa Rica: CONIS procedure CONIS.01.09 (2025); CCSS memo CENDEISSS-AB-0115-2024.
Dominican Republic: CONABIOS operating manual, 2nd edition; Provision 004-A-2004.
Ecuador: ARCSA clinical trial authorization page.
El Salvador: SRS clinical trial evaluation route (2025), authorization guide v01 (2025) and SRS–CNEIS platform instructions (2025).
Guatemala: MSPAS Ministerial Agreement 206-2021, clinical trial regulation.
Mexico: Agreements published in the DOF on 28 April 2025 and 4 May 2026; ClinRegs Mexico (NIH); COFEPRIS press release 16/2025 (22 May 2025).
Panama: Executive Decree 21 of 2026 (Gaceta Oficial 30510-C).
Peru: Supreme Decree 021-2017-SA (MINSA); ClinRegs Peru (NIH), citing Supreme Decrees 021-2017-SA and 010-2025-SA.
Uruguay: Decree 158/019 (IMPO).
United States: 21 CFR 312.40, 812.2 and 812.30 (eCFR).
Canada: Health Canada CTA and ITA guidance documents.
Argentina, observed: CAEME, as reported by Economis (2022).
Region: Zavaleta-Monestel et al., Cureus, 2026.
bioaccess® study timelines (Gantt charts) for drug and device studies in Panama, El Salvador, Chile and Colombia, 2022 to 2026, de-identified.