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International health regulation

Elizabeth M Mudge, Ying Liu, Jensen A Lund, Paula N Brown
Suitably validated analytical methods that can be used to quantify medicinally active phytochemicals in natural health products are required by regulators, manufacturers, and consumers. Hawthorn (Crataegus) is a botanical ingredient in natural health products used for the treatment of cardiovascular disorders. A method for the quantitation of vitexin-2″-O- rhamnoside, vitexin, isovitexin, rutin, and hyperoside in hawthorn leaf and flower raw materials and finished products was optimized and validated according to AOAC International guidelines...
October 24, 2016: Planta Medica
Francis Barchi, Madison T Little
BACKGROUND: Ethical and regulatory guidance on the collection and use of human biospecimens (HBS) for research forms an essential component of national health systems in Sub-Saharan Africa (SSA), where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks. METHODS: An extensive multi-level search for publicly available ethics regulatory guidance was conducted for each SSA country...
October 22, 2016: BMC Medical Ethics
Yong Zhang, Bing Yu, Jun He, Daiwen Chen
Skeletal muscle is a remarkably complicated organ comprising many different cell types, and it plays an important role in lifelong metabolic health. Nutrients, as an external regulator, potently regulate skeletal muscle development through various internal regulatory factors, such as mammalian target of rapamycin (mTOR) and microRNAs (miRNAs). As a nutrient sensor, mTOR, integrates nutrient availability to regulate myogenesis and directly or indirectly influences microRNA expression. MiRNAs, a class of small non-coding RNAs mediating gene silencing, are implicated in myogenesis and muscle-related diseases...
2016: International Journal of Biological Sciences
U Walter, K Volkenand
Municipalities have an overarching structure in health promotion. Due to the right to self-government, municipalities are in charge of both voluntary and obligatory tasks. Some of the original and fundamental tasks can be summarized as "services to the public". Current common definitions do not include the term "health promotion". In the present study, a sub-target of a joint project, legal acts, requirements and recommendations were researched and analyzed. The results show substantive cornerstones of health promotion in various regulations of different disciplines...
October 18, 2016: Das Gesundheitswesen
Marcos Espinal, Sylvain Aldighieri, Ronald St John, Francisco Becerra-Posada, Carissa Etienne
The World Health Organization's determination of the Ebola virus disease outbreak as a public health event of international concern prompted non affected countries to implement measures to prevent, detect, and manage the introduction of the virus in their territories. The outbreak provided an opportunity to assess the operational implementation of the International Health Regulations' core capacities and health systems' preparedness to handle a potential or confirmed case of Ebola virus disease. A public health framework implemented in Latin America and Caribbean countries encompassing preparatory self-assessments, in-country visits, and follow-up suggests that the region should increase efforts to consolidate and sustain progress on core capacities and health system preparedness to face public health events with national or international repercussions...
March 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Julian Schenten, Martin Führ
The purpose of the REACH Regulation is to ensure a high level of protection of human health and the environment as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. To this end, REACH introduces, among other instruments, the authorisation regime for substances of very high concern (SVHC) that are listed on Annex XIV of the regulation. After expiration of the transitional period for each Annex XIV-SVHC, articles, such as most products of daily use, produced in the European Economic Area (EEA) may not contain such substances unless an authorisation was granted for the specific use or this use falls within the scope of an exemption from the authorisation requirement...
2016: Environmental Sciences Europe
Soteri Polydorou, Stephen Ross, Peter Coleman, Laura Duncan, Nichole Roxas, Anil Thomas, Sonia Mendoza, Helena Hansen
OBJECTIVES: This report identifies the institutional barriers to, and benefits of, buprenorphine maintenance treatment (BMT) integration in an established hospital-based opioid treatment program (OTP). METHODS: This case study presents the authors' experiences at the clinic, hospital, and corporation levels during efforts to integrate BMT into a hospital-based OTP in New York City and a descriptive quantitative analysis of the characteristics of hospital outpatients treated with buprenorphine from 2006 to 2013 (N=735)...
October 17, 2016: Psychiatric Services: a Journal of the American Psychiatric Association
Camille Yip, Nian-Lin Reena Han, Ban Leong Sng
Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research...
September 2016: Indian Journal of Anaesthesia
Shoaib Fahad Hussain, Peter Boyle, Preeti Patel, Richard Sullivan
Since the launch of the Global Polio Eradication Initiative (GPEI) in 1988 the global incidence of poliomyelitis has fallen by nearly 99 %. From a situation where wild type poliovirus was endemic in 125 countries across five continents, transmission is now limited to regions of just three countries - Pakistan, Afghanistan and Nigeria. A sharp increase in Pakistan's poliomyelitis cases in 2014 prompted the International Health Regulations Emergency Committee to declare the situation a 'public health emergency of international concern'...
October 12, 2016: Globalization and Health
Roland Solecki, Andreas Kortenkamp, Åke Bergman, Ibrahim Chahoud, Gisela H Degen, Daniel Dietrich, Helmut Greim, Helen Håkansson, Ulla Hass, Trine Husoy, Miriam Jacobs, Susan Jobling, Alberto Mantovani, Philip Marx-Stoelting, Aldert Piersma, Vera Ritz, Remy Slama, Ralf Stahlmann, Martin van den Berg, R Thomas Zoeller, Alan R Boobis
Endocrine disruption is a specific form of toxicity, where natural and/or anthropogenic chemicals, known as "endocrine disruptors" (EDs), trigger adverse health effects by disrupting the endogenous hormone system. There is need to harmonize guidance on the regulation of EDs, but this has been hampered by what appeared as a lack of consensus among scientists. This publication provides summary information about a consensus reached by a group of world-leading scientists that can serve as the basis for the development of ED criteria in relevant EU legislation...
October 6, 2016: Archives of Toxicology
Rasmus Borup, Susanne Kaae, Timo Minssen, Janine Traulsen
BACKGROUND: Many areas of pharmaceutical legislation in the European Union (EU) are harmonised in order to promote the internal market and protect public health. Ideally, harmonisation leads to less fragmented regulation and cross-border complexities. This study, however, focuses on an increasingly harmonised legislative area that is subject to increases in requirements and complexities: the distribution of medicines. This study compared Danish legislation governing the distribution of medicines before and after Denmark joined the EU in order to assess the impact of EU harmonisation, as well as to evaluate whether the drastic increases in requirements mandated by the Falsified Medicines Directive of 2011 correspond to a new approach to governing the pharmaceutical supply chain...
2016: Journal of Pharmaceutical Policy and Practice
Mary Kay Kindhauser, Tomas Allen, Veronika Frank, Ravi Shankar Santhana, Christopher Dye
OBJECTIVE: To describe the temporal and geographical distribution of Zika virus infection and associated neurological disorders, from 1947 to 1 February 2016, when Zika became a Public Health Emergency of International Concern (PHEIC). METHODS: We did a literature search using the terms "Zika" and "ZIKV" in PubMed, cross-checked the findings for completeness against other published reviews and added formal notifications to WHO submitted under the International Health Regulations...
September 1, 2016: Bulletin of the World Health Organization
Ana Paula Jucá Silva, Patrícia Oliveira Pereira Tagliari
The present article describes the changing relationship among healthcare regulatory authorities in various international settings, with special emphasis on the Americas. As other sectors, healthcare also faces the need to regulate international practices, while at the same time taking into consideration the specific realities of each country. Regulatory convergence - a movement towards technical alignment to enable the adoption of local regulatory mechanisms that take into account internationally recognized standards and principles to promote a single sanitary goal - has emerged as a means to address this challenge...
May 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Dulce María Martínez Pereira, Yadira Álvarez Rodríguez, Yamila Cedeño Valdés, Silvia Delgado Ribas
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...
May 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Lisette Pérez Ojeda, Rafael Pérez Cristiá
Health technology regulation and quality assurance are critical to the development of national pharmaceutical policies, and implementing these actions is the responsibility of national regulatory authorities, whose level of development and maturity affect the quality, safety, and effectiveness of the products made available to the public. On the initiative of the regulatory authorities themselves, together with the Pan American Health Organization, the Region of the Americas promotes the strengthening of health regulation through an evaluation and certification process that allows for the designation of regulatory authorities of regional reference for drugs and biological products...
May 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Christiane Maia, Dirce Guilhem
Objective To outline and discuss the main challenges for sanitary regulation contained in the federal-level Brazilian health policy. Methods For the present qualitative study, based on the analysis of public policies, information was collected from documents and interviews. Document analysis provided a historical overview of the insertion of sanitary regulation into the Brazilian health policy between 1999 and 2009 (first decade of existence of the national health surveillance agency, Anvisa). In addition, 13 interviews were carried out with actors selected for their historical, technical, or academic role in the field...
May 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Varley Dias Sousa, Pedro I Ramalho, Dâmaris Silveira
Regulatory transparency is an imperative characteristic of a reliable National Regulatory Authority. In the region of the Americas, the process of building an open government is still fragile and fragmented across various Health Regulatory Agencies (HRAs) and Regional Reference Authorities (RRAs). This study assessed the transparency status of RRAs, focusing on various medicine life-cycle documents (the Medicine Dossier, Clinical Trial Report, and Inspection Report) as tools for strengthening health systems...
May 2016: Revista Panamericana de Salud Pública, Pan American Journal of Public Health
Martin Zavadil, Vladimír Rogalewicz, Ivana Kubátová, Veronika Matloňová, Kristýna Salačová
Hospital-based HTA (HB-HTA) consists in implementation of assessment activities "in" or "for" hospitals; hence, it covers processes and methods supporting organization and execution of health technology assessment (HTA) at the level of individual hospitals. This process is multidisciplinary, systematic and evidence-based.HB-HTA objectives and methods differ from the classic utilization of HTA at the national regulator level. Most experience and information concerning HB-HTA has originated in two large recent projects: activities of the HB-HTA Interest Group of the HTAi international association established in 2006, and the AdHopHTA European research project (20122015)...
2016: Casopís Lékar̆ů C̆eských
D Habes, R Mahzia, K Nakhleh, E Joury
No study has investigated the availability and adherence of preventive oral care products on the Syrian market to evidence-based international recommendations. Data were collected in 2012, and updated in 2016, in terms of availability, characteristics and adherence to evidence-based international recommendations. Few preventive products adhered to the recommendations. Despite the large decrease in the number of oral care products on the Syrian market, due to the Syrian crisis, nonadherence of some of the available products is still present...
2016: Eastern Mediterranean Health Journal, la Revue de Santé de la Méditerranée Orientale
Moazzam Ali, Ayse Akin, Luis Bahamondes, Vivian Brache, Ndema Habib, Sihem Landoulsi, David Hubacher
STUDY QUESTION: Is it possible to extend the use of the 3-year one-rod etonogestrel (ENG)-releasing subdermal contraceptive implant to 5 years? SUMMARY ANSWER: The extended use of the one-rod ENG-releasing subdermal contraceptive implant showed 100% efficacy in years 4 and 5. WHAT IS KNOWN ALREADY: The initial regulated trials on the ENG-releasing subdermal contraceptive implant conducted in the 1990 s were designed to measure cumulative 3-year efficacy...
September 26, 2016: Human Reproduction
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