Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research Applications.

INTRODUCTION: Promptly providing new drugs to fulfill unmet medical needs requires changes in drug development and registration processes. Health Authorities (HAs) considered as reference due to their experience and acknowledgement (Food and Drug Administration [FDA] among others) already consider innovative clinical trial (CT) designs and flexible approval procedures, but Latin America (LATAM) regulations are still far. A comparison was performed to identify gaps. MATERIALS AND METHODS: CT requirements for drug Marketing Authorization Application (MAA) and CT approval regulations were compared between LATAM and reference HAs (FDA/European Medicines Agency [EMA]/Health-Canada/Swissmedic/Therapeutic Goods Administration [TGA]/Pharmaceuticals and Medical Devices Agency [PMDA]), as of August 2022. Procedure included reference HAs regulations review, item selection, identification in LATAM regulations, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (ICH-E6[R2]/ICH-E8[R1]) implementation revision. RESULTS: For MAA, specific application requirements or ICH guideline M4(R4) on common technical document (CTD) adoption are generally stated, and phase-I/III performance is mandatory (explicitly/implicitly). Faster patient access procedures are infrequent: Priority-drug programs, conditional authorizations, or expedited procedures are scarce or non-existent. Regulatory reliance procedures are adopted through different pathways. Regarding CT approval, innovative/complex CT designs are not prohibited but usually omitted. Some countries implemented adapted CT conducting during the COVID-19 pandemic. Early scientific advice meetings (HA-sponsor) are occasionally considered. Most countries are not formally ICH-joined. CONCLUSIONS: LATAM regulations must adapt to new regulatory standards (FDA/EMA/ICH) through implementation of frequent updates, reliance/expedited procedures, early HA-sponsor interactions, innovative/complex CTs, mandatory phase-III reaching elimination, and decentralized elements for CT conducting.

[Prevalence of renal artery stenosis in patients with critical limb ischemia]. / Prevalencia de estenosis de la arteria renal en los pacientes con isquemia crónica grave de extremidades inferiores.

BACKGROUND AND OBJECTIVE: Our purpose was to evaluate the prevalence of renal artery stenosis in patients with critical limb ischemia and to study any clinical or laboratory indicator that could predict this association. PATIENTS AND METHOD: One hundred consecutive patients with critical limb ischemia evaluated by angiogram were included in the study from January to July 2003. Cardiovascular risk factors and renal function were analyzed. RESULTS: One hundred angiographic studies have been analyzed. Thirty nine (39%) of our patients had some type of pathology of the renal artery but the rest, 61 (61%), had normal and healthy renal arteries. In 5 patients, a bilateral renal pathology was found. Severe disease (> 60% stenosis, bilateral or renal occlusion) was present in 15 cases including 6 occlusions. Once we compared the patients with healthy renal arteries with the patients with different degrees of stenosis, we did not appreciate significant differences in hypertension, diabetes, coronary disease or smoking habit, nor with laboratory data such as creatinine, urea, c-reactive protein, total cholesterol or atherogenic index. No differences were found either comparing patients with normal renal artery with patients with bilateral pathology or with unilateral occlusion. CONCLUSIONS: There is a high prevalence of renal artery pathology in patients with critical limb ischemia although we have not found any clinical or laboratory factors useful to identify them.

Análise dos resultados dos 100 primeiros aneurismas da aorta abdominal operados em um serviço de angiologia e cirurgia vascular / Outcome of the first 100 abdominal aortic aneurisms treated surgically in an angiology and vascular surgery service

Estudar as características dos pacientes e avaliar os resultados imediatos do tratamento cirúrgico dos 100 primeiros casos de aneurisma da aorta abdominal näo-rotos operados em um Serviço de Angiologia e Cirurgia Vascular, identificando os possíveis fatores prognósticos relacionados à mortalidade precoce...