May 20, 2026
7
min read
By
bioaccess®
On April 23, 2026, Panama enacted Decreto Ejecutivo No. 21 of 2026, published the same day in Gaceta Oficial No. 30510-C. For sponsors weighing where to run a first-in-human or early-feasibility study in Latin America, this is the most important Panamanian regulatory development in years — and the headline is counterintuitive but important: Panama just made its clinical research rules more detailed and more enforceable, and that is good news.
Here is the key to understanding it. Panama's foundational health-research law, Ley 84 of 2019, set out the principles years ago — but Titles III and IV of that law, the parts that define how the national bioethics system and the research registry actually operate, had never been implemented. Decreto 21/2026 is the regulation that finally switches them on. In one stroke, Panama moved from "we have a law" to "we have a working, operational system with defined timelines, accountable committees, and a national registry." For sophisticated sponsors, that shift from principle to operational clarity is exactly what de-risks a site decision.
In short
On April 23, 2026, Panama enacted Decreto Ejecutivo No. 21, implementing Titles III and IV of Ley 84 of 2019 — accredited ethics committees, the RESEGIS national research registry, statutory review timelines, and codified sponsor duties. For sponsors, the shift from principle to operational clarity de-risks site decisions and makes Panama a more credible place to generate early clinical evidence.
What is Decreto 21 of 2026?
Decreto Ejecutivo No. 21 of 2026 implements Titles III and IV of Ley 84 of May 14, 2019. It runs to 15 chapters and 105 articles, was signed by the President of the Republic and the Minister of Health, and took effect immediately on promulgation. It repealed and replaced the earlier patchwork that had governed Panamanian research bioethics — including the 2014 decree that originally created the national committee, a 2015 decree, and a 2003 resolution — consolidating everything into a single, current instrument.
In plain terms, the decree does three things: it defines how research ethics committees are accredited and how they operate, it formalizes the national research registry, and it sets the rules of the road for clinical trials with medicines and health products.
What changed? The provisions sponsors should know
A national registry is now mandatory before you start. Every health-research study must be registered in RESEGIS (Registro y Seguimiento de la Investigación para la Salud), the Ministry of Health's research registry, before execution begins. Registration is the principal investigator's responsibility, and the decree is explicit that a clinical trial's details must appear in a publicly accessible, WHO-standard-compliant registry before the trial starts. The registration receipt is issued within three business days for standard projects. This is Panama's analogue to the registration discipline sponsors already expect from ClinicalTrials.gov.
Ethics committees are now accredited and tiered. Only research bioethics committees (CBIs) accredited by the national committee (CNBI) may review and approve protocols. The decree creates two accreditation tiers: Type I for minimal-risk studies, and Type II for studies involving intervention — including clinical trials. A clinical trial must go to a Type II-accredited committee. Multicenter trials are approved by a single accredited committee, avoiding the duplicate-review problem that slows studies in some markets.
Ethics-review timelines are now defined in law. Ordinary review is capped at 20 business days, expedited review at 10 business days (for minimal-risk studies or those already approved by recognized high-standard international bodies), and exemption decisions at 5 business days. Approval certification is issued within three business days of the decision. Defined statutory timelines are the single most valuable thing a sponsor can get from a regulator — they make a study calendar real instead of aspirational.
Regulatory and ethics review run in parallel for high-risk protocols. For high-risk studies, the Ministry of Health's evaluation and the ethics committee's review happen simultaneously, not sequentially, with the MINSA result entered into RESEGIS at the same time it goes to the committee. Parallel review compresses startup timelines — a meaningful advantage over jurisdictions where each gate must clear before the next opens.
Safety reporting is on a defined clock. The decree sets explicit adverse-event reporting timelines: serious adverse events occurring in Panama must be reported to the approving ethics committee within 24 hours, and serious international adverse events within 15 days of the sponsor's report. Pharmacovigilance is further coordinated through RESEGIS in a unified process between the Directorate of Public Health, the National Directorate of Pharmacy and Drugs (DNFD), and the national committee.
Sponsor obligations are now explicit and enforceable. The decree assigns the sponsor direct duties: maintain a resident principal investigator, conduct periodic site monitoring and report deviations to both the approving committee and the regulator, provide financial provisions for the compensation of research-related harm, and support knowledge and technology transfer to the local institution. Vulnerable-population and pediatric protections are codified as well — for studies involving minors, formal assent is required from age seven, alongside parental consent.
Why is a more detailed framework a win for sponsors?
It is tempting to read "more regulation" as "more friction." For experienced sponsors, the opposite is true:
- Defined timelines beat open-ended ones. A 20/10/5-business-day ethics clock and a three-business-day registration receipt let you build an accurate study calendar and budget. Ambiguity is what kills timelines — not rules.
- Parallel review is faster, not slower. Running MINSA evaluation and ethics review simultaneously for high-risk protocols is a structural speed advantage the decree now guarantees.
- The data travels. Studies conducted under a clear, WHO- and ICH-aligned framework — with registry discipline and defined safety reporting — produce data that regulators in the US, EU, and elsewhere are more willing to accept.
- It de-risks the site decision. When committee accreditation, sponsor duties, and reporting timelines are codified, the question "what happens here if something goes wrong?" has an answer in writing. That is precisely the assurance a clinical-operations director or a sponsor's legal team needs before approving a Latin American site.
What does it change operationally?
If you are planning a study in Panama, the new framework affects five practical workstreams:
- Study registration: budget time and ownership for RESEGIS registration as a gating step before first-patient-in.
- Ethics committee selection: confirm your committee holds Type II accreditation from the CNBI — only Type II committees can approve clinical trials.
- Startup sequencing: for high-risk protocols, plan around parallel MINSA + ethics review rather than a sequential queue.
- Pharmacovigilance: wire your safety reporting to meet the 24-hour (national) and 15-day (international) serious-adverse-event clocks and the RESEGIS notification process.
- Sponsor commitments: structure your agreements and budgets around the codified sponsor duties — resident PI, monitoring, and financial provisions for harm compensation.
A practical note on transition: the decree took effect immediately, with a short window (roughly three months) for already-accredited committees to align their standard operating procedures to the new rules. Studies in startup now should assume the new framework applies.
How does Panama compare in the Latin American context?
None of this changes the underlying reason sponsors come to Panama. The country still offers some of the fastest ethics timelines in the region, cost structures meaningfully below US and EU benchmarks, and — under the separate Ley 419 of 2024 — an expedited device-registration pathway that recognizes FDA and other high-standard-country clearances. What Decreto 21/2026 adds is the operational backbone: accredited committees, a national registry, defined timelines, and codified safety reporting.
The honest caveat is the one that has always applied to Panama: a smaller population and a limited number of research-ready hospitals mean site and indication selection matter more here than in larger markets. That is a solvable problem with the right local partner and the right protocol fit — exactly the feasibility judgment a specialized first-in-human CRO is built to make.
The bottom line: what should sponsors do?
Decreto 21 of 2026 is the sound of Panama professionalizing. By implementing the long-dormant Titles III and IV of its 2019 health-research law, Panama has given sponsors what they value most: defined timelines, accredited and accountable ethics committees, a national registry, and clear safety-reporting obligations. The right reaction for a sponsor is not hesitation — it is recognition that Panama is becoming a more, not less, credible place to generate the early clinical evidence an FDA or CE submission depends on. For the data-acceptance framework, see our FDA acceptance guide for Latin American first-in-human studies and our Latin America vs US/EU clinical trial cost benchmark.
bioaccess® runs first-in-human and early-feasibility studies across Latin America, with deep operational experience in Panama's MINSA, CNBI, and CBI pathways. If you are evaluating Panama for an upcoming program, request your FIH roadmap and we will map the regulatory pathway, indicative timeline, and indicative budget for your specific asset.
Frequently asked questions
What is Decreto 21 of 2026?
Decreto Ejecutivo No. 21 of 2026 implements Titles III and IV of Ley 84 of May 14, 2019. It runs to 15 chapters and 105 articles, was signed by the President of the Republic and the Minister of Health, and took effect immediately on promulgation on April 23, 2026.
What is RESEGIS?
RESEGIS (Registro y Seguimiento de Investigaciones en Salud) is Panama’s national health-research registry. Every health-research study must be registered in RESEGIS before starting.
What changed for sponsors?
Accredited ethics committees, a mandatory national registry, statutory review timelines, and codified sponsor duties — including unified safety reporting coordinated through RESEGIS.
Why is this good news for sponsors?
Operational clarity — defined timelines, accredited and accountable ethics committees, a national registry, and clear safety-reporting obligations — de-risks site decisions and makes Panama a more credible place to generate the early clinical evidence an FDA or CE submission depends on.
This article is for general informational purposes and reflects bioaccess®'s reading of Decreto Ejecutivo No. 21 of 23 April 2026 (Gaceta Oficial No. 30510-C), which implements Titles III and IV of Ley 84 of 2019. It is not legal advice. Sponsors should confirm current requirements with Panamanian regulatory counsel before relying on them for a specific study. Primary source: Ministerio de Salud de Panamá, Decreto Ejecutivo No. 21 de 23 de abril de 2026.
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