Two questions come up in nearly every first-in-human conversation I have with a device sponsor. I reviewed Panama's ethics-review decree in full so the answers below rest on the law itself — not on lore.
October 5, 2026
8
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
In short
Panama does not require efficacy or function data before a first-in-human device study, and no provision of Decreto Ejecutivo 21/2026 prescribes a functional large-animal study. The ethics committee judges the safety case plus the risk-benefit profile under Article 50 of the decree. A comparable Class III spinal hydrogel was approved for first-in-human use in Colombia with no large-animal work at all — but expect a US IDE to still require GLP data with implantation at the intended site.
The recurring question
In nearly every first-in-human conversation I have with a device sponsor, two questions surface — usually together, usually with some anxiety attached:
- Does the ethics committee or the health ministry expect us to demonstrate efficacy — or at least function — before the first human is treated? Or is generating that evidence the purpose of the study itself?
- Is a functional large-animal study a requirement for approval? For a spinal device, that usually means a porcine or ovine spine model — months of work and meaningful cost.
Sponsors hear conflicting things because two different documents get conflated: the typical industry package sponsors assemble (large-animal models, functional outcomes, histology and imaging correlation) and the actual regulatory requirement. They are not the same thing. What follows is the requirement, grounded in the decree itself — we read Decreto Ejecutivo 21/2026 end to end.
The legal basis: Ley 84 and Decreto 21/2026
Panama's clinical-research framework rests on Ley 84 of May 14, 2019, which regulates and promotes health research. Titles III and IV of that law — the provisions governing ethics review — were implemented by Decreto Ejecutivo No. 21 of April 23, 2026. Two articles of the decree do the heavy lifting for device sponsors:
- Article 50 sets the ethics committee's review criteria: scientific validity and a favorable risk-benefit assessment. The committee judges whether the study is scientifically sound and whether the risk to participants is justified — it does not work from a mandated test battery.
- Article 102 requires animal-ethics review and GLP conduct where preclinical studies are performed. It governs how animal work is conducted under Panamanian jurisdiction; it does not determine which animal work must exist before a first-in-human study.
That last point deserves emphasis because it is the entire answer in miniature: no article of the decree prescribes a specific animal model, species, study duration, or functional study. The framework is sponsor-driven — the sponsor assembles the evidence it believes demonstrates a reasonable risk-benefit profile for first human use, and the committee evaluates it.
Is efficacy data required before FIH?
No. Neither MINSA's published framework nor the ethics-committee system requires a demonstration of efficacy or clinical function as a precondition for a first-in-human feasibility study. What the committee requires is a safety case — ISO 10993 biocompatibility, bench performance, sterility and endotoxin data, an ISO 14971 risk file, and an investigator's brochure — together with a credible scientific rationale for anticipated benefit as part of the risk-benefit assessment.
That rationale matters. For a permanent, non-degrading implant, the anticipated-benefit story carries real weight in the risk-benefit calculus, and in-vitro human-tissue data (for example, suppression of catabolic markers in human nucleus pulposus tissue for a disc device) plus published peer-reviewed data on the material platform is exactly the right evidence for it. But preliminary clinical performance is an exploratory objective of the feasibility study, not a prerequisite for starting it. That is the universal structure of an early feasibility study — and Panama's decree is built around it.
Is a functional large-animal study required?
No. As established above, no provision of Decreto 21/2026 mandates an animal model or a functional study. A porcine or ovine spine study would strengthen a degenerative-disc-device package, and it may be expected later by FDA for an IDE — but it is not a gate for Panama FIH approval.
Two qualifications, stated plainly. First, the absence of a mandate does not prevent the committee from conditioning approval on additional data or protocol safeguards — that is within its Article 50 discretion, and the decree is recent enough that post-decree precedent is still limited. Second, where you do run animal work, Article 102's GLP and animal-ethics expectations apply; we recommend any planned chronic safety study be conducted under GLP, or with a documented gap plan, because the US file will need it in any event.
Framework vs. precedent: what was actually accepted
This is where the confusion usually starts. A typical pre-study memorandum describes the full industry framework — rodent proof-of-concept, porcine or ovine spine models as "standard for DDD devices," functional outcomes with histology and imaging correlation. Then it describes what regulators actually accepted for a comparable program. Those are two points on a spectrum, not contradictory requirements.
The precedent: ReGelTec's HYDRAFIL, a Class III implantable hydrogel for degenerative disc disease, was approved for first-in-human use by Colombia's INVIMA and the independent ethics committee on a biocompatibility file compiled under the ISO 10993 series — cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, and 2- and 13-week subcutaneous implantation with histopathology — plus genotoxicity and chemical characterization with toxicological risk assessment, GLP where applicable. No large-animal study. No spine model. No implantation at the intended anatomical site.
Treat that precedent as strong persuasive context, not as a binding commitment from any committee. It was decided under Colombia's framework, and every protocol is judged on its own risk-benefit profile. But it establishes the floor: ethics committees in the region have approved first-in-human spinal implants on a focused biocompatibility-led package, and a sponsor whose planned package exceeds that floor negotiates from strength.
The honest caveats
A straight answer includes what the law does not promise:
- Parallel MINSA review for high-risk devices. For a permanent implantable device in the decree's high-risk intervention track, expect parallel MINSA technical review alongside ethics review. That review does not add an efficacy precondition — the criteria remain safety case plus risk-benefit — but the pathway is ethics committee plus MINSA, not ethics committee alone.
- The US IDE will still want the large-animal data. For a US IDE (early feasibility or pivotal) and the EU/UK Class III route, expect GLP preclinical data including implantation at the intended site to be required. Panama FIH data can reduce but will rarely replace that file.
- Design for repatriation from day one. Under 21 CFR 812.28, the FDA accepts foreign clinical data when the study is conducted under GCP with adequate documentation and the agency can validate the data. Run the Panama study to ISO 14155 with inspectable records, and the dataset comes home into the IDE.
- "Biological" gets scrutinized. If a device contains animal- or human-derived material, expect sourcing, viral-safety, and classification questions in every jurisdiction. Chemical characterization should address both the uncured precursor and the cured implant, and permanence and irretrievability must be explicit in the informed consent, the risk file, and the long-term follow-up plan.
Procedural basics for a Panama FIH
For planning purposes, the operating facts under Decreto 21/2026:
- Review by a CNBI-accredited Type II ethics committee — 20 business days for ordinary review, 10 business days expedited, with a 30-business-day total cap.
- RESEGIS registration — Panama's national health-research registry — plus institutional conformity from the hospital.
- Spanish-language protocol package: investigator's brochure, informed consent form, and insurance certificate, with clinical-trial insurance in place.
See also our 2026 update of the LATAM EFS regulatory framework and why U.S. companies run first-in-human trials overseas.
Our position, stated plainly: bioaccess advises on U.S. EFS versus Latin America FIH strategy from Miami and executes first-in-human trials across 19 Latin American and Caribbean countries. We tell sponsors honestly which geography their program needs — including when the answer is "run the large-animal study first" — rather than selling one answer.
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