Clinical trials in Panama: Law 84, the CNBI and registration

What Law 84 of 2019 says about who approves a clinical trial in Panama

Law 84 of May 14, 2019, published in Gaceta Oficial Digital 28775-A on May 16, 2019, regulates and promotes health research and establishes its oversight and governance⁸. Its Title III creates the National Research Bioethics Committee (CNBI) and accredited research bioethics committees (CBIs). The Ministry of Health (Minsa) guide explains that all research with human participants must have the approval of an accredited committee before it begins³.

Title IV, articles 49 to 54, sets the obligations for all health research: a protocol, the agreement of the institution where the study will take place, and registration with Minsa³. According to the Panamanian press, the CNBI is responsible for monitoring compliance with ethical review; it traces back to a 1999 Minsa resolution, and a 2012 decree gave it the function of accrediting, supervising and auditing local and institutional CBIs¹³. In April 2026 Minsa published Executive Decree 21, which regulates Titles III and IV of Law 84 (Gaceta Oficial 30510-C, April 23, 2026)⁹.

The three-step flow: institution, Minsa and bioethics committee

The Minsa guide describes three processes. First, the approval or non-objection of the institution where the research is proposed. Second, registration of the protocol with the Health Research Regulation unit through the RESEGIS platform, with the protocol and its annexes (timeline, budget, informed consent and data collection instrument) in the same version the committee will see³. Third, ethical review by a CBI accredited by the CNBI; where applicable, it can run in parallel with Minsa's evaluation³.

Checking a complete registration takes at most three working days. When the protocol is high risk, such as a clinical trial, it is evaluated with a response within 30 calendar days at most, based on the criteria of article 54: that the study does not interfere with public health activities or endanger the health of the population and the environment³. Minsa's flowchart also covers, where applicable, the import permit procedure³.

How many clinical trials are there in Panama: Minsa and FIFARMA figures

Minsa's quarterly report as of June 30, 2026 counted 392 protocols received and processed in the second quarter, of which 9 were clinical trials, or 2.3% of the total⁶. Its charts show between 11 and 30 clinical trials registered per year since 2016, with 30 in 2023, 22 in 2024, 25 in 2025 and 16 so far in 2026⁶. The trials received in the quarter were reviewed by several Minsa technical units, including the National Directorate of Pharmacy and Drugs (DNFD), which evaluated four⁶.

A different measurement, from the report of the Latin American Federation of the Pharmaceutical Industry (FIFARMA) prepared by the consultancy CIDI Salud on studies started between 2020 and 2024 in ten countries, places Panama at 10 studies per million inhabitants, third behind Chile (25) and Argentina (23); 91% were industry-funded, 40% were phase 3 and 42% early phase¹. The two sources measure different things (national registry versus studies started, according to the report) and should not be compared number to number. Carmen Da Silva, of Fedefarma, said the government has made clinical trials "a national investment priority"¹.

In October 2026, Roche executives told La Estrella de Panamá that the country has high-level clinics and trained staff able to lead trials in the region, and that the crucial point is that, when the study ends, the state ensures the patient keeps the treatment².

What a bioethics committee reviews: consent, insurance and adverse events

The evaluation guide of the Gorgas Memorial Institute bioethics committee (CBI-ICGES), dated August 25, 2022, shows what is examined in practice⁵. Its checklist asks for references to the Declaration of Helsinki, Law 68 of 2003 on patient rights in free and informed decisions, the Good Clinical Practice standards of the International Conference on Harmonisation, and the CIOMS guidelines⁵. It also checks adverse event collection (reporting deadlines by severity), the insurance policy or certificate for the investigator and the site, the economic report, the suitability of the principal investigator and the facilities, and that the participant information sheet explains risks, alternatives, the right to withdraw and compensation for harm⁵.

Those criteria are consistent with the Declaration of Helsinki as revised in 2024, which replaced "subjects" with "participants" and asks that all individuals and organizations doing medical research uphold its principles¹⁰¹². The new version also requires consent to collect, store and reuse biological material and data¹². Published analyses compare the 2024 version with the 2013 one¹¹¹⁵.

Research is not sanitary registration: the difference that matters to physicians

The DNFD, under Law 419 of 2019 as cited in its clinical trial material, oversees the quality, safety and efficacy of medicines and human health products also while they are in research and development⁷. That phase is not the same as sanitary registration: it is the status of a product still under study. The same DNFD material describes approval as a system with informed consent, ethical evaluation and supervision during the trial, and mentions recognition of other agencies' decisions and participation in multinational trials⁷.

Stem cells illustrate the point. In August 2026, the CNBI president, Luis Coronado, warned that the only recognized therapeutic use in Panama is hematopoietic transplantation, that any other use is experimental and can only happen within approved research, and that trial participants should not pay to take part¹⁴. He added that no stem cell trial protocols had been submitted to the CNBI since 2018¹⁴. More context in Stem cells in Panama: medical tourism without evidence.

Reading the Minsa guide, the practical consequence is twofold. If a study includes people, it needs a registered protocol and the approval of an accredited committee before it starts³. And a product labeled "research use only" replaces neither step and is not the equivalent of sanitary registration. How each kind of product is treated is developed in Sanitary registration: the question asked of peptides but not of exosomes, and the physician's map of responsibilities in Prescribing, importing, administering and in the Peptides in Panama 2026 guide.

Law 409 and pediatric research: an unresolved uncertainty

The framework is not free of friction. In August 2025, La Prensa reported that article 98 of Law 409 of 2023, which prohibits experimental practices that may endanger the life or dignity of children and adolescents, had not yet been regulated⁴. Researcher Xavier Sáez-Llorens, of the Hospital del Niño, argued that the DNFD director's interpretation exceeded his functions and could leave children in "therapeutic and preventive orphanhood"⁴. The director, Uriel Pérez, answered that a protocol approved by a bioethics committee does not contravene that article and that his criterion would stand until the law is regulated⁴. We did not find in the sources reviewed whether Executive Decree 21 of 2026 settled that point⁹.