Argentina clinical trial regulatory guide

Regulator: ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica)

Argentina has modernized its clinical-research framework in recent years, with ANMAT operating risk-stratified approval tracks, parallel ethics review, and alignment to ICH E6(R3) Good Clinical Practice standards. Argentina became a full Regulatory Member of ICH in June 2024, and ANMAT's current regime provides dedicated requirements for Phase I and first-in-human studies, including Phase I center accreditation. Buenos Aires is a major clinical research hub with experienced investigators. (The specific instrument, effective date, and any binding statutory approval-timeline figures are pending verification against the official gazette.)

Approval process

1. Pre-Submission Meeting (FIH/Phase I). Mandatory pre-meeting with ANMAT for Phase I and first-in-human studies to establish scientific basis and identify data requirements. Optional for Phase II/III.
2. Parallel ANMAT + Ethics Submission. Under ANMAT's current regime, simultaneously submit to ANMAT and an accredited Comité de Ética en Investigación (CEI). ANMAT conducts scientific/technical review while the CEI independently evaluates ethical dimensions.
3. ANMAT Technical Review. Risk-stratified review: lower-risk studies are reviewed faster than standard/Phase I studies, following an initial administrative acceptance check. Specific statutory day-counts are pending verification against the official gazette.
4. Provincial Authorization. Some provinces require additional health authority approval beyond ANMAT.
5. Import Authorization. Obtain ANMAT import permit for investigational devices.
6. Site Activation. Finalize site contracts and begin enrollment.

Ethics requirements

• Accredited Comité de Ética en Investigación (CEI) review — now runs in parallel with ANMAT review (not sequential)
• Informed consent in Spanish, per Argentine regulations and ANMAT's current requirements
• Mandatory participant insurance
• Continuing review at the interval the ethics committee sets
• Ethics review is fully delegated to the CEI — ANMAT focuses on scientific/technical evaluation

Documentation requirements

• Protocol and amendments in Spanish
• Investigator brochure (Spanish preferred)
• Device technical file with risk analysis
• GMP/ISO 13485 certificates
• Insurance coverage documentation
• Provincial regulatory requirements (varies by province)
• Phase I center accreditation documentation (Annex V) for FIH studies
• Pre-submission meeting minutes (mandatory for Phase I/FIH)

Device registration

Argentina follows ANMAT's risk-based classification system. Device registration requires a local authorized representative, technical documentation, and typically varies by study (we confirm it per protocol). ANMAT recognizes FDA and CE approvals as supporting evidence but conducts independent review.

FDA acceptance of Argentina data

FDA accepts Argentine clinical data under 21 CFR 812.28 when studies comply with ICH-GCP. Argentina's full ICH membership (June 2024) and adoption of ICH E6(R3) further strengthen the acceptability of Argentine data for FDA submissions. Protocols built to FDA IDE or EMA standards require minimal Argentine-specific adaptation.

Key contacts

• ANMAT — National Drug, Food & Medical Technology Administration (ICH Full Regulatory Member since June 2024)

Frequently asked questions

What is Argentina's new clinical trial approval timeline?

Argentina's current ANMAT framework uses risk-stratified review with parallel ethics review; low-risk studies are reviewed faster than standard/Phase I studies. Specific statutory day-count figures are pending verification against the official gazette.

Does Argentina require provincial approval?

Some provinces require additional health authority authorization beyond ANMAT approval, which can add time that varies by study (we confirm it per protocol).

Can I run a first-in-human trial in Argentina?

Yes. ANMAT's current framework provides a dedicated first-in-human pathway with pre-submission meetings and Phase I center accreditation requirements. Argentina offers competitive review timelines for FIH programs.

Is ANMAT aligned with ICH standards?

Yes. ANMAT became a full ICH Regulatory Member in June 2024 and has adopted ICH E6(R3), along with ICH E2A, E2F, and E3 guidelines.

What are the currency considerations?

Argentina's currency fluctuations can affect trial costs. Contracts should include provisions for exchange rate variability.

Can Argentine data support FDA submissions?

Yes. FDA accepts Argentine clinical data under 21 CFR 812.28 when generated under ICH-GCP and ISO 14155 protocols. Argentina's ICH membership and E6(R3) adoption further streamline FDA acceptance.

All Latin America regulatory guides · Book a free 30-min strategy call