Centro Para El Control Estatal Of Medicamentos

Havana, Cuba

Centro Para El Control Estatal Of Medicamentos

Havana, Cuba
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PubMed | Elettra - Sincrotrone Trieste, University of Trieste, Health Physics, University "Marta Abreu" of Las Villas and Centro Para El Control Estatal Of Medicamentos
Type: Journal Article | Journal: International journal of computer assisted radiology and surgery | Year: 2016

Phase-contrast mammography with synchrotron radiation is an innovative X-ray imaging practice that improves the identification of breast lesions. Previous studies have proven the superiority of the mammography images taken in the phase-contrast modality using synchrotron radiation beams as compared with images taken in conventional mammography by subjective analyses. However, to our knowledge, no previous study has compared different acquisition systems in order to quantify this improvement by means of objective robust indicators. In this research, we intend to quantify the superiority of phase-contrast imaging by means of objective metrics of image quality.Images from the American College of Radiology Mammographic Accreditation Phantom were obtained at hospitals, in two digital mammography equipment and at the Elettra synchrotron radiation facility (Trieste, Italy), using free space propagation phase-contrast modality. Regions of interest were selected to analyze image quality at the fibers (phase object) and masses (area object) simulated on the phantom by means of the signal-to-noise ratio, the figure of merit, the contrast and the edge visibility.The image contrast and edge visibility were significantly higher at the phase-contrast modality as compared with digital mammography equipment. The figure of merit using phase-contrast modality was higher for the fibers and comparable for the masses.The results showed an improvement of the contrast and edge visibility in phase-contrast images. These improvements may be important in the detection of small lesions and details.

Diaz M.F.,Sociedad Medica Terapeutica LTDA | Garcia K.,CSIC - National Center for Metallurgical Research | Meneau R.I.,Centro Para El Control Estatal Of Medicamentos | Sanchez Y.,Centro Para El Control Estatal Of Medicamentos | Garcia G.,Institute Farmacia y Alimentos
Journal of Pharmacy and Pharmacognosy Research | Year: 2015

Context: Ozonized vegetable oils present germicidal effects which can be used as active principle in different cosmetological compositions. The thematic about of the corporal massage advantage have been very treatment by aesthetics, dermatologic and consumers. OLEOMASAJE formulation content ozonized sunflower oil OLEOZON as active principle active which present moisturizer and conditioner effects. Aims: To determine the possible dermal and ophthalmic irritability effects of the OLEOMASAJE. Methods: The trial was conducted in rabbits and the techniques described in the standardized procedures of the work established by the Center of Biological Research and Evaluations from Pharmacy and Food Institute of Havana University were used according to Norma ISO 10993-10. The ethical principles of the Good Practices of Laboratory were fulfilled to avoid suffering to the animals during the experimentation. Male rabbits with body weight between 2.05 and 2.48 kg were used. In the skin and the ocular structures the effects were observed immediately after of the application at 1, 24, 48 and 72 hours. Draizés scale was applied to evaluate skin and ocular structures lesions. Results: The OLEOMASAJE formulation does not irritate de skin of the assayed rabbits. However, the ocular structures irritability index was of 4.5 after of first hour to apply of product. These wounds were missing before of 24 hours to apply of product. Conclusions: The OLEOMASAJE formulation obeys the indispensable requirements for the acceptance as cosmetic product and for it is used in corporal massage. © 2015 Journal of Pharmacy & Pharmacognosy Research,.

Alfonso Orta I.,Centro Para El Control Estatal Of Medicamentos | Toledo Romani M.E.,Institute Medicina Tropical Pedro Kouri IPK | Coutin Marie G.,University of Habana | Garcia Farinas A.,Escuela Nacional de Salud Publica ENSAP La Habana | And 2 more authors.
Revista Cubana de Salud Publica | Year: 2016

Introduction: Availability and irrational consumption of antimicrobials prompt their inadequate use and sometimes give rise to adverse reactions. At present, these reactions represent a clinical and epidemiological problem. It is necessary to deepen into the knowledge about their characteristics in Cuba and the behavior in the course of time for the decision making process. Objectives: To characterize the adverse antimicrobial reactions reported in Cuba and to analyze the behavior of tendencies, seasonality and prognosis for 2013 and 2014. Methods: Longitudinal and descriptive study of case series in a ten-year period (2003-2012). Data were taken from national pharmacovigilance databases. Results: There were registered 40 391 reports of adverse antimicrobial reactions accounting for 86.5 % of the total number of adverse reactions. They prevailed in females (64.3 %) and in under one-year old infants. The skin illnesses represented 47.9 % and digestive ones 26.8 %. Penicillin G was the most reported drug. Moderate adverse reactions prevailed (58.2 %). Tendency was growing, seasonality was observed and prognosis was on the rise. Conclusions: The increase in the number of reports of adverse antimicrobial reactions and the anticipated rise of them is an alert to the health care system. © 2016, Editorial Ciencias Medicas. All rights reserved.

Ruiz Salvador A.K.,La Habana | Garcia Milian A.J.,Escuela Nacional de Salud Publica ENSAP | Alonso Carbonell L.,Centro Nacional Coordinador Of Ensayos Clinicos Cencec | Jimenez Lopez G.,Centro Para El Control Estatal Of Medicamentos | And 2 more authors.
Revista Cubana de Plantas Medicinales | Year: 2015

Introduction: increase in the consumption of natural products is largely due to the perception that being “natural” can only be beneficial and without risk to health. Objective: To characterize the adverse reactions associated with the use of herbal medicines sold in Cuba for the period 2003-2010. Methods: Observational, descriptive and transversal study. Was eligible for the study all reports of suspected adverse drug reactions (ADRs) herbal medicines produced by the National Coordinator of Pharmacovigilance Unit during the study period. Results: Most of the reports of suspected adverse reactions were distributed in females (67.3 %) and in the age group of 31-60 years (52.5 %). Predominant gastrointestinal disorders such as epigastria pain (17.9) and vomiting (10.5). Garlic tincture and syrup (14.0 %) and Aloe Vera L (7.7) were the most commonly reported herbal medicines. The organ most affected by adverse reactions was the tract. Most of them were classified probable mild. Conclusions: Adverse reactions, for herbal medicines, reported the Cuban system of pharmacovigilance are mostly mild, occur in adult women and Digestive and skin more often. © 2015, Editorial Ciencias Medicas. All rights reserved.

Enriquez N.,Organizacion Panamericana de la Salud | Alvarez Y.,Centro Para El Control Estatal Of Medicamentos | Martinez D.M.,Centro Para El Control Estatal Of Medicamentos | Perez A.,Ministerio de Salud Publica | Lemgruber A.,Organizacion Panamericana de la Salud
Revista Panamericana de Salud Publica/Pan American Journal of Public Health | Year: 2016

Objective. To describe and analyze the current status of and the challenges involved in the regulation of medical devices in the Region of the Americas and to present the results of the regional mapping exercise, progress toward the development of advanced assessment indicators, and the achievements of the Regional Working Group. Methods. Creating a regional profile on the regulation of medical devices in the Americas is a priority for the Working Group. To this end a tool composed of 45 questions organized into six sections was developed and distributed among 15 countries for self-assessment (the participation rate was 100%). Based on the data received, nine basic indicators were established and an agreement was reached to develop advanced indicators for measuring the extent to which regulatory programs for medical devices were being implemented. Results. Of the 15 countries, 93% have an agency in charge of regulating medical devices. An analysis of individual country performance shows wide variability, with some countries meeting all indicators and others meeting as few as 11%. The mapping also made it possible to generate information on collaborative partnerships, training, and regulation. Conclusions. The results show significant heterogeneity at the regional level. Implementation of advanced indicators will help to identify areas of opportunity and strengths for the development of the regulatory profile. Although progress has been made toward strengthening regulatory programs for medical devices, remaining gaps need to be bridged through strategies and initiatives to be led by the Working Group.

Sanchez-Gonzalez C.,Centro Para El Control Estatal Of Medicamentos | Debesa-Garcia F.,Centro Para El Control Estatal Of Medicamentos | Yanez-Vega R.,Centro Para El Control Estatal Of Medicamentos | Lopez-Romo A.,Centro Para El Control Estatal Of Medicamentos
Revista Cubana de Plantas Medicinales | Year: 2014

Introduction: Natural and traditional medicine (NTM) has gained space in Cuban health and society. Objectives: characterize NTM regulations and contribute to their development by means of the retrieval of national regulations about standards for NTM drugs and medical devices. Methods: a descriptive cross-sectional retrospective study was conducted. The regulatory bases were retrieved from a review of scientific papers published between 1989 and 2012, as well as work sessions with key officials and interviews with experts. Results: a total 22 regulations were collected. The Center for State Control of the Quality of Drugs and Medical Equipment (CECMED) was identified as among the 6 main regulators in this field, with 5 institutions regulated. Conclusions: for the first time a general overview was provided of the evolution of NTM regulations, their milestones, structures and development needs. It was shown that CECMED has accomplished the mandate of the Council of Ministers about regulation in this field, and that it investigates strategies aimed at fulfilling the directives received in relation to the transformation of the Cuban economic and social development model ensuring the quality, safety, efficacy and efficiency of NTM drugs and medical devices to preserve the right of Cubans to health care. © 2014, Editorial Ciencias Medicas. All rights reserved.

Objective. To review, organize, and share the experience of the regulatory authorities of countries involved in a project headed by the Bolivarian Alliance for the Peoples of Americas (ALBA) for the establishment of a regulatory center (ALBAMED) and a single registry to facilitate access to essential medicines while ensuring quality, safety, and effectiveness, as well as to demonstrate how the construction of this forum for regional cooperation has benefited these authorities and their respective regulatory systems. Methods. A descriptive, longitudinal, and retrospective study of ALBAMED's activities between 2009 and 2014 using published and archived materials. The level of agreement was determined by means of surveys; and joint development of standards, knowledge transfer, and the identification of best practices were assessed. Results. The regulatory authorities of Bolivia, Cuba, Ecuador, Nicaragua, and Venezuela participated in the project. Twenty-five comparative assessments of the status of regulation in nine key areas were carried out. Six coordination meetings and four specialized workshops were held. More than 130 provisions and procedures were approved, having been developed specifically for the ALBAMED Regulatory Center or adopted from guidelines issued by the World Health Organization and the Pan American Health Organization. Conclusions. The mapping exercise for a regulatory center and supranational registry for ALBA countries has enhanced the performance of participating authorities and strengthened drug regulatory systems through the development and selection of the standards to be applied, knowledge transfer, and the promotion of best practices.

Pereira D.M.M.,Centro Para El Control Estatal Of Medicamentos | Rodriguez Y.A.,Centro Para El Control Estatal Of Medicamentos | Valdes Y.C.,Centro Para El Control Estatal Of Medicamentos | Ribas S.D.,Centro Para El Control Estatal Of Medicamentos
Revista Panamericana de Salud Publica/Pan American Journal of Public Health | Year: 2016

Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country's national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.

Gonzalez Ramirez M.C.,Centro Para El Control Estatal Of Medicamentos
Revista Cubana de Plantas Medicinales | Year: 2013

Introduction: the World Health Organization recommended the countries, the establishment of a National Committee of Experts to identify the necessary measures and plans to formulate a national policy on traditional medicine. The Cuban Drug Regulatory Authority named Center for State Control of Drugs, Equipment and Medical Devices (CECMED) was created in December 2011 by the Committee of Experts on Natural and Traditional Medicine to replace the Quality Committee of Drugs of Natural Origin created in 2002. Objectives: to present the structure and internal regulations of the committee as an advisory organ of CECMED to evaluate specific issues and make recommendations that contribute to collegial decision process of CECMED. Methods: the Internal Regulations of Committee of Experts on Natural and Traditional Medicine (Approved as Appendix 1 in the 134-2008 Resolution, Regulations for the selection and management of experts of CECMED) was developed using the methodology of literature review of different committees of experts, mainly the Committee on Herbal Medicinal Products of the European Medicines Agency. Results: the composition of the Committee of Experts on Natural and Traditional Medicine is identified as well as the organization and function of its parts and its responsibilities, among other aspects. Conclusions: the implementation of the internal regulations will allow a better organization and performance of the functions of the committee in each of the activities and tasks planned for the development of traditional medicine.

Garcia Farinas A.,Escuela Nacional de Salud Publica ENSAP | Felix Garcia Rodriguez J.,Juarez Autonomous University of Tabasco | Galvez Gonzalez A.M.,Escuela Nacional de Salud Publica ENSAP | Jimenez Lopez G.,Centro Para El Control Estatal Of Medicamentos
Revista Cubana de Salud Publica | Year: 2016

Objective: To determine the methodical quality of complete economic evaluations published in Cuban medical journals from 1999 to 2014. Methods: Observational, descriptive and cross-sectional study of articles classified by their authors as complete economic evaluations and published from 1999 to 2014 in 47 Cuban medical journals authorized by the Ministry of Science, Technology and Environment. The applied evaluation guide included year of publication, journal, objective, problem, options, time frame, prospects, cost, health effects and estimation of the cost/effectiveness ratio. Results: Twenty one papers were found, but in the last three years no paper has been published. These papers were mainly published in eight journals, being the first Revista Cubana de Farmacia, followed by Revista Cubana de Salud Publica and MEDISAN. None of the aspects was correctly addressed in over 80 % of revised papers. The worst results were found in statement of perspective present in less than 20 % of papers in addition to sensitivity analysis in less than 30 % of them. Almost 50 of papers adequately dealt with the submission of research problems, objectives, time frame, costs and the incremental cost/effectiveness ratio. Conclusions: Published economic evaluations are still scanty and most of them exhibit methodological faults. There is insufficient development in this area nationwide, which points to the importance of insisting once again on the dissemination of the basic methodological aspects of these evaluations aimed at researchers who act as reviewers and as editors of scientific journals. © 2016, Editorial Ciencias Medicas. All rights reserved.

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