Chile’s clinical trial approval pathway runs on two parallel tracks that both have to clear before a study can start: an ethics/scientific review by an accredited Comité Ético Científico (CEC), and a separate authorization from Chile’s national regulatory authority, the Instituto de Salud Pública (ISP), acting through its medicines agency ANAMED (Agencia Nacional de Medicamentos). Neither approval substitutes for the other, and confusing the two — or confusing this clinical-trial pathway with a separate 2025 ISP resolution about marketing-authorization reliance for biologics — is a common source of timeline mistakes for sponsors new to Chile. This guide walks through both tracks, how they interact, and what a February 2025 ISP resolution does and does not change.
The regulatory authorities: ISP and ANAMED
The Instituto de Salud Pública de Chile (ISP) is Chile’s national public health institute and the country’s medicines regulatory authority, functionally comparable to a national medicines agency elsewhere in Latin America (e.g. INVIMA in Colombia). Within the ISP, ANAMED is the sub-directorate responsible for medicines specifically — sanitary registration (marketing authorization), pharmacovigilance, and the authorization of pharmaceutical products used in human clinical investigation. ANAMED’s Clinical Trials unit, situated within its sanitary registration and authorization structure, evaluates requests to import and use pharmaceutical products that do not yet hold Chilean marketing authorization for use in a clinical study, and monitors the trial sites and laboratories that conduct this kind of human research.
The legal basis for Chile’s clinical trials system rests on the country’s Sanitary Code (Código Sanitario) together with implementing regulation issued by the Ministry of Health and technical norms published by the ISP that set out accreditation requirements for ethics committees and the procedural detail of trial authorization. Sponsors should always confirm the current in-force version of this implementing regulation and the applicable ISP technical standard directly against ispch.gob.cl before filing, since procedural detail (forms, required annexes, specific timelines) is the kind of thing that gets updated at the resolution level more often than the underlying statute.
Step 1: Ethics and scientific review by an accredited CEC
A clinical trial in Chile cannot start without written, dated authorization from a Comité Ético Científico (CEC) — Chile’s equivalent of an institutional review board / research ethics committee. The principal investigator files the study protocol with a CEC accredited to review the relevant type of research; the committee evaluates the scientific design, the risk-benefit balance, informed consent materials, and participant-protection arrangements. Only once the CEC has issued its written approval can the trial proceed to the next stage.
The CEC’s oversight role does not end at initial approval. The principal investigator is expected to keep the CEC informed of the trial’s progress at defined intervals, submit protocol amendments for CEC review before they take effect, and provide a copy of the trial’s final report at study close.
Step 2: ISP/ANAMED authorization to import and use the investigational product
In parallel with (or following) CEC review, the sponsor must obtain authorization from the ISP, issued through ANAMED, to import and use the investigational pharmaceutical product in Chile. This is a separate administrative act from the CEC’s ethics approval — it is the ISP’s confirmation that the specific product, its manufacturing/quality documentation, and the conditions of use proposed in the protocol meet the country’s requirements for investigational use of an unregistered (or off-label) pharmaceutical product. The ISP issues this authorization by resolution. Published third-party regulatory-affairs summaries commonly describe the ISP’s evaluation period as running around 30 calendar days from a complete submission, though sponsors should treat that as an indicative planning figure rather than a statutory guarantee, and should confirm current service timelines directly with ANAMED or a locally qualified regulatory affairs consultant, since these figures are the kind of operational detail that shifts between resolutions.
Because both approvals are required and neither authority substitutes for the other, sponsors typically plan for CEC and ISP/ANAMED review to run on overlapping but independently-tracked timelines, and build in contingency for either body to return questions or requests for clarification — a common driver of overall approval delay in Chile, as in most dual-track systems.
After approval: amendments, safety reporting, and ongoing obligations
Once a trial is underway, any change to the approved protocol must be notified to both the CEC and the ISP/ANAMED — a change accepted by one body is not automatically recognized by the other. Sponsors also retain the standard ongoing obligations common to most clinical-trial regulatory regimes: safety reporting for serious or unexpected adverse events, periodic progress reporting to the CEC, and recordkeeping sufficient to support ISP inspection of trial sites and the laboratories or centers conducting the study.
What Resolution E679/25 actually covers — and what it doesn’t
Sponsors researching Chile’s regulatory landscape will frequently encounter Exempt Resolution E679 of 2025 (published in Chile’s Official Gazette on 5 February 2025), sometimes described loosely as a “2026 regulatory reliance framework.” It is worth being precise about what this resolution actually does, because it is not part of the clinical-trial approval pathway described above.
Resolution E679/25 establishes an internal ISP procedure for applying a regulatory reliance mechanism — in line with World Health Organization guidance encouraging national regulators to draw on prior evaluations by other trusted regulatory authorities rather than duplicating full independent review — specifically for granting sanitary registration (marketing authorization) of biological pharmaceutical products. In other words, it speeds up the ISP’s review of an application to market a biologic medicine in Chile once it has already been evaluated and approved by a recognized foreign regulator. It has no bearing on the CEC/ISP-ANAMED authorization pathway a sponsor uses to open and run a clinical trial. A sponsor planning a Chilean trial should not expect E679/25 to shorten CEC review, ISP/ANAMED investigational-product authorization, or any other step in the trial-approval sequence described above; its relevance is confined to post-trial marketing-authorization applications for biological products, and only where a qualifying foreign approval already exists.
How Chile compares to Colombia’s INVIMA pathway
Chile’s dual-track CEC-plus-ISP/ANAMED model is structurally similar to the approach used in several other Latin American jurisdictions, including Colombia, where INVIMA’s clinical trial approval pathway likewise pairs an institutional ethics committee review with a separate no-objection authorization from the national regulator (INVIMA, under Resolution 2378 of 2008). The practical implication for multi-country Latin American trials is the same in both jurisdictions: ethics-committee approval and national-regulator authorization are separate workstreams with separate submission packages, and a sponsor cannot treat one as a proxy for the other when building a regional study timeline.
Frequently asked questions
Do the CEC and ISP/ANAMED approvals happen in a fixed order?
The CEC’s written ethics/scientific authorization is a precondition for the trial to proceed, and sponsors commonly submit to ANAMED once CEC review is underway or complete; the practical sequencing and any allowance for parallel filing should be confirmed against current ISP procedural guidance, since both approvals are ultimately required regardless of filing order.
What does ANAMED actually evaluate, as distinct from the CEC?
ANAMED evaluates the investigational pharmaceutical product itself — its manufacturing and quality documentation and the conditions under which an unregistered or off-label product may be imported and used in Chile — and authorizes that use by ISP resolution. The CEC evaluates the trial’s scientific design, risk-benefit balance, and participant protections. They are complementary, not overlapping, reviews.
Is Exempt Resolution E679/25 a clinical trial approval mechanism?
No. E679/25 establishes a reliance procedure for ISP review of sanitary registration (marketing authorization) applications for biological pharmaceutical products — a post-trial, product-registration process, not a mechanism for authorizing or accelerating a clinical trial’s approval.
Who is responsible for notifying protocol amendments?
The sponsor and principal investigator are responsible for submitting protocol amendments to both the CEC and the ISP/ANAMED; approval by one body does not extend to the other.
This guide describes the general structure of Chile’s clinical trial regulatory pathway based on ISP/ANAMED’s public description of their roles and published legal/regulatory-affairs analysis of Resolution E679/25. Procedural specifics — required forms, exact review timelines, and in-force regulation numbers — change at the resolution level; sponsors should confirm current requirements directly against ispch.gob.cl before filing.
