Brazil's regulator processed ten sponsor protocol and dossier changes and sponsor-requested withdrawals in one week, while El Salvador's published device-trial pathway and a conversation with Axoft's product chief round out a deliberately quiet LATAM news cycle.
ANVISA · Brazil clinical trials · El Salvador medical device pathway · regulatory intelligence · Axoft podcast
Two ANVISA resolutions dated three days apart show a regulator processing its clinical-trial queue in both directions: authorizing forward progress for ten sponsors, then publishing sponsor-requested cancellations for a separate set of expedientes. There is no new first-in-human or Phase 1 activity elsewhere in Latin America this week, and that silence is worth noting. Below: what Brazil's regulator approved and cancelled, El Salvador's published device-trial pathway, and a spotlight on the latest Global Trial Accelerators™ Podcast episode with Axoft's Chief Product Officer.
ANVISA's Resolução-RE Nº 2.854, dated July 20, 2026 and published in the Diário Oficial da União on July 21, 2026, granted petitions handled by ANVISA's Coordenação de Pesquisa Clínica em Medicamentos e Produtos Biológicos, covering protocol, product, and dossier changes across ten sponsor and product records (ANVISA/DOU RE 2.854). By sponsor, per the resolution's annex:
Insight — portfolio maintenance, not new launches. The resolution changes protocols and investigational products already inside Brazil's pipeline, not net-new first-in-human activity (ANVISA/DOU RE 2.854). Each change still required ANVISA sign-off under RDC 585/2021, reflecting the continuous-submission review framework introduced by RDC 945/2024 (ANVISA clinical research regulation).
Three days later, ANVISA published Resolução-RE Nº 2.912, dated July 23, 2026 and published in the Diário Oficial da União on July 24, 2026, announcing the cancellation, at sponsor request, of petitions and processes tied to the same coordination unit (ANVISA/DOU RE 2.912). The resolution's annex lists Pharmaceutical Research Associates Ltda (clinical-research consent for a biological product, process 25351.447166/2023-31), Takeda Farmacêutica Brasil Ltda (synthetic-drug development-dossier consent, process 25351.392449/2022-58), and PPD do Brasil Suporte a Pesquisa Clínica Ltda (synthetic-drug clinical-research consent, process 25351.423632/2022-11) (ANVISA/DOU RE 2.912).
Insight — sponsor-initiated, not regulator-initiated. The resolution cites no safety rationale; it documents a cancellation at the sponsors' own request, signed by Claudiosvam Martins Alves de Sousa, Coordenador de Pesquisa Clínica em Medicamentos e Produtos Biológicos, effective on the date of publication (ANVISA/DOU RE 2.912). A cancellation record does not indicate a safety problem.
MedTech sponsors evaluating device studies in Central America have an official, published pathway to work from. El Salvador's SRS publishes clinical-investigation instructivos covering protocol authorization, content requirements, supply validation, adverse-event notification, investigator manuals, and trial closeout (SRS clinical investigation instructions).
For device studies specifically, the official SRS pathway article publishes a four-step authorization sequence involving the Dirección Nacional de Medicamentos (DNM), the national regulator, and the Comité Nacional de Ética en Investigación en Salud (CNEIS), the ethics committee (official SRS device clinical-trial pathway article):
Insight — a published sequence, not a parallel track. The official diagram presents these four steps as an ordered flow; it does not state that DNM and CNEIS review runs in parallel. Both bodies must issue a favorable opinion, and DNM supervises device clinical trials in national territory (official SRS device clinical-trial pathway article). Sponsors should confirm current routing and step order directly with SRS before planning around these timelines.
We did not find a third qualifying first-in-human, Phase 1, or early feasibility trial-activity item for Latin America this week that met our freshness bar. Two candidates were set aside: bioaccess®'s own previously reported Axoft program at The Panama Clinic (bioaccess® Axoft case study), and a gene-therapy trial whose ANVISA authorization and first dosing predate this window.
Insight — discipline over volume. A quiet week reflects duplicate and stale items filtered out rather than recycled as new, the point of a weekly regulatory digest held even when the trial-activity section runs short.
Colombia's INVIMA regulatory intelligence continues to be tracked separately and is noted here strictly as intelligence, not as a recommendation to place trial execution in Colombia.
The latest Global Trial Accelerators™ Podcast episode features Matt DeNardo, Chief Product Officer at Axoft, on how engineering rigor, regulatory strategy, and clinical collaboration move medical technologies from concept to first-in-human readiness (Matt DeNardo, Chief Product Officer at Axoft). DeNardo brings a systems-engineering and design-thinking background to translating unmet clinical needs into product strategy, and the conversation covers risk reduction and the operational decisions that shape the path toward FIH studies.
For a device study mapped against Brazil's dossier requirements or El Salvador's pathway, bioaccess® can walk through the primary sources with you.
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