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Introduction: Clinical trials that involve medicines are performed in order to determine their effectiveness and safety. In Argentina, these studies are presented either to National Administration of Drugs, Food and Medical Technology (ANMAT) to obtain drug registration, or to the National Ministry of Health (MSAL) (to obtain the official recognition). This work was carried out to increase the knowledge about the clinical trials performed in Argentina., Materials and Methods: The MSAL/ANMAT databases were explored. The variables were: dates of request, institution, phase of the study, enrollment modality, product investigated, therapeutic group, comparator, pathology involved, and location of laboratory performance., Results: A total of 201 protocols were detected in the period of study, all of them performed with registration purposes. Twenty pharmaceutical companies carried out 60% of the studies (17 with foreign capital). Seventy percent were phase III (90% multicenter protocols). Three out of 4 trials corresponded to the oncology / immunosuppressant therapeutical group. In 65% the comparator used was placebo. A 71% of the studies were carried out in health institutions of Buenos Aires City. Ninety-eight per cent of laboratory controls were carried out abroad., Discussion: Foreign pharmaceutical companies are the only ones that carry out clinical trials on medicines in Argentina, all of them for registration purposes. The use of placebo as a comparator is inappropriate, since each drug is expected to be validated against another of recognized efficacy already available in the market. Oncological/immunological pathologies are the ones that arouse greater interest among local researchers due to their prevalence and their greater profitability in the pharmaceutical market.

Introduction: Knowing the characteristics of the pharmaceutical market allows obtaining sensitive information to understand the supply, demand and access of the population to medicines. In order to provide primary data regarding the marketing of drugs in Argentina, the following research was performed., Method: This is a cross-sectional quantitative-qualitative descriptive study of the Argentine pharmaceutical market, taking into account 30 years of official information provided by the National Regulatory Agency (ANMAT)., Results: Two hundred and sixteen laboratories (182 national) drug producers / importers, 53 distributors and 479 drugstores (wholesale drug distribution establishments) were identified. A high concentration of marketing was detected, grouping 90% in only 5 intermediaries. There are currently 6670 products/certificates in the country, an amount that fluctuated over the last 30 years. Six laboratories are owners of between 116 and 208 certificates; 84% of these products come from national laboratories, 5002 are mono-drugs, while 83% are marketed under a fancy name. The three main indications for which the registration of drugs in Argentina is intended are diseases of digestive system, nervous system and infectious diseases; 58% of the marketed products consist of oral formulations., Discussion: Based on data provided by this study, it is possible to assert that the Argentinian pharmaceutical market has a majority share of national capital, with a great concentration in a few pharmaceutical companies and distributors. The products are mostly available as non-combined drugs, in their oral form, and available by their brand names.

Background: Irrational use of antimicrobials (ATMs) triggers microbial resistance (AMR) which has severe consequences for human health. ATM consumption varies among countries and within each territory. These data should be known, in order to perform local policies towards AMR reduction. This work aimed to expose the association of the level of consumption of carbapenems and fluoroquinolones with their resistance rates in Pseudomonas aeruginosa in Argentina., Method: Consumption of antimicrobials was expressed by defined daily dose (DDD)/1000 inhabitants for each ATM during one year period, discriminating by each country region. Resistance of P. aeruginosa to carbapenems/fluoroquinolones groups was recorded. Consumption/resistance ratio "R" was calculated for each region of the country, comparing results with other countries., Results: P . aeruginosa resistance rate to fluoroquinolone (F) was 26.4% in blood samples and 29.7% in urine samples, whereas resistance rates to carbapenems (C) were 19.9 and 17.7% in blood and urine, respectively. Correlation between consumption and resistance was demonstrated for both antimicrobials (C :  R  = 0.58; p =0.003 and F :  R  = 0.77; p =0.0001). Great fluctuations of resistance levels were seen among regions within the country, always correlating resistance with areas in which a higher level of ATM consumption was detected., Conclusion: P. aeruginosa resistance to fluoroquinolone/carbapenems in Argentina directly correlated with antimicrobial consumption levels. A great heterogeneity in resistance profile was observed among areas where ATMs were widely used. Global data at the national level might mask local realities that require specific health policies in order to control the irrational use of ATMs., Competing Interests: The authors declare that they have no conflicts of interest., (Copyright © 2022 Silvia Boni et al.)