Post-trial access (PTA) is the continued supply of an investigational product to trial participants after the study ends — when the protocol, ethics committee, and local rules require or allow it. Sponsors running multi-country Latin American trials need one place to see which markets mandate PTA, which do not, how to diligence an operator, and where country-specific filing and import steps live. This page is that operator hub: link-forward, scannable, and built for discoverability when PTA is no longer a footnote in the CTA.
bioaccess® is a LATAM-native clinical and regulatory operator. We combine regulatory strategy, importadora (importer of record) capability, and Good Distribution Practice (GDP)–aligned logistics so PTA obligations are planned into the trial — not discovered at last patient last visit (LPLV).
Start here: operator map + diligence checklist
- LATAM post-trial access operator map — country-by-country classification (binding mandate, weak instrument, or no mandate), who the obligor is, and whether a filing sits outside the trial dossier.
- How to evaluate a LATAM PTA operator (10-question diligence checklist) — what to ask before you hand PTA continuity to a CRO, local agent, or third-party logistics partner.
If you only have ten minutes: open the map for your protocol countries, then run the checklist against whoever would own import, warehouse, and patient-level supply after LPLV. Countries with no mandate still need a documented ethics-committee position; mandate countries need cohort size, duration, and cold-chain cost in the budget before first patient in.
Country pillars (binding or high-visibility regimes)
These four jurisdictions are where sponsors most often need a dedicated PTA plan — a statute, decree, or disposition that creates a real post-trial supply or filing pathway:
- Brazil — Lei 14.874: statutory post-trial framework; plan cohort size, duration, and import early.
- Peru — DS 021-2017-SA: post-trial continuity rules under the clinical research regulation; align ethics and import before close-out.
- Panama — Decreto Ejecutivo 21/2026 Art. 68: newer executive decree language on post-trial access; treat as an operator-map update, not a verbal assurance.
- Argentina — ANMAT Disp. 12792/2016 (cohort PTA vs RAEM): cohort post-trial pathway versus per-patient régimen de acceso excepcional a medicamentos (RAEM); pick the right channel before you invent a hybrid.
Related country reading when it sits on your protocol list: Chile Ley 20.850 (Ricarte Soto) PTA context. For how obligation language and import mechanics interact across the region, see legal architecture of LATAM post-trial access.
Medical devices: which LATAM countries mandate PTA?
Drug and device rules do not always move together. A pharma PTA clause copied into a device clinical trial agreement can over- or under-commit you. Before you lock CTA language, check the device-specific mandate map: Which LATAM countries mandate PTA for medical devices?
PTA is not compassionate use or expanded access
Post-trial access (PTA) continues supply for people who already participated in your trial, under the ethics-approved protocol and local research framework. Compassionate use / expanded access is a separate, usually per-patient pathway for patients outside the trial (or for indications and settings the protocol never covered). Mixing the two in the CTA or the importadora paperwork creates the wrong filing, the wrong labeling path, and the wrong warehouse story. Use PTA language for trial-cohort continuity; use compassionate use / expanded access only when that is the actual regulatory channel — and name it explicitly in the protocol, the informed consent, and the import plan.
Colombia and other no-mandate markets
Do not invent a statutory PTA duty for Colombia. On the operator map, Colombia sits with Mexico, Paraguay, El Salvador, the Dominican Republic, Cuba, and Puerto Rico in the no-mandate set: there is no binding sponsor duty to keep supplying investigational product after the trial solely because a PTA statute says so. That does not mean “ignore continuity.” Ethics committees and informed consent still ask for a documented position; a sponsor may run a voluntary continuity program on its own initiative, routed through the ethics committee and local operational agreements. Read the map for the jurisdiction list and the Colombia note rather than treating silence as a hidden mandate: LATAM PTA operator map.
How bioaccess® helps
bioaccess® operates as a Latin America–native partner across the three layers sponsors usually under-staff for PTA:
- Regulatory — classify each protocol country (mandate / weak instrument / no mandate), draft the PTA position for ethics and CTA language, and sequence any post-trial filing that sits outside the trial dossier.
- Importadora — hold or coordinate importer-of-record steps so continued supply is a planned import path, not an emergency shipment after LPLV.
- GDP — Good Distribution Practice–aligned storage, temperature control, and chain-of-custody so post-trial units stay audit-ready from release to patient.
We do not invent rates or client outcomes on this page. If your protocol already lists Brazil, Peru, Panama, Argentina, Chile, or a multi-country mix that includes no-mandate markets, bring the country list and we will map obligation versus voluntary continuity against the live operator map and the diligence checklist.