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Lancet publishes editorial about Universal Health Care in 21st century Americas

Despite considerable progress, the Pan American Health Organization (PAHO) estimates that 30% of the population of the Americas still do not have access to the health care they need because of multifaceted barriers. On April 9, leaders, including Mexico’s President Andrés Manuel López Obrador, PAHO director Carissa Etienne, and UN High Commissioner for Human Rights Michelle Bachelet, gathered with academics, activists, and representatives of social movements in Mexico City to hear the report of the Commission on Universal Health in the 21st Century (…) https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)30864-5/fulltext

 
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Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada

March 19, 2019
Our file number: 19-101967-390

Under the Regulatory Review of Drugs and Devices initiative, Health Canada is increasing the efficiency of the regulatory system and supporting timely access to therapeutic products. As part of this initiative, Health Canada is pleased to announce the launch of the e-Learning tool, Understanding How Medical Devices are Regulated in Canada – Premarket Regulation.

This web-based tool, designed as an interactive learning platform, offers an overview of Health Canada’s premarket regulatory requirements for medical devices. It also provides targeted guidance to enable greater consistency in the understanding, interpretation and application of the Food and Drugs Act, the Medical Devices Regulations and their related policies and guidelines.

The tool serves as a valuable, comprehensive, and organized source of premarket regulatory information for various medical device stakeholder groups, including manufacturers, importers, distributors, consultants, healthcare groups, and academia. By providing e-Learning content to  manufacturers and other relevant stakeholders, it is expected that the completeness and quality of Medical Device Licence applications will improve, thereby resulting in more positive, and more timely, regulatory decisions.

Health Canada encourages and invites stakeholders to utilize and benefit from this new educational tool.

Questions or concerns regarding this notice or the e-Learning tool should be directed to the Medical Devices Bureau at hc.mdb.enquiries-enquetes.bmm.sc@canada.ca.

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/announcements/notice-e-learning.html

 
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29 Marzo – Webinar RedETSA – Modelo Web de Análisis de Impacto Presupuestario

Nos complace compartir invitación al programa de webinars de la Red de Evaluación de Tecnologías en Salud de las Américas (RedETSA) el día 29 de marzo a las 11am (EST), en la cual el Lic. Alfredo Palacios, del Instituto de Efectividad Clínica y Sanitaria (IECS) hará una presentación sobre “Modelo web de análisis de impacto presupuestario”.

El link de WebEx que utilizaremos es el siguiente: https://goo.gl/Rxrxki

 
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Caribbean Regulatory System Recommends Hepatitis C Cure    

Recently, the CARPHA/CRS recommended Gilead’s Epclusa (sofosbuvir 400mg/velpatasvir 100mg) film-coated tablet for the treatment of Hepatitis C.

The product is the first combination of its kind, and is listed on the WHO Essential Medicine List. It is also a first line therapy as recommended by WHO. The rationale for such an important status is that Epclusa is curative for all genotypes of Hepatitis C. If not treated, Hepatitis C can lead to negative health outcomes like liver failure and cancer.

This is a significant development for patients in CARICOM because there are estimated to be perhaps 100,000 cases of Hepatitis C in the region, but few authorized treatments. Epclusa, for example, does not have marketing authorization in any CARICOM state. It is also significant for public health. Cures such as this one are critical to strategies to eliminate Hepatitis C in the Americas.

Patients need access to these innovative therapies quickly, and major manufacturers are increasingly using the CRS because of the efficiencies it brings in speeding access to medicines. The CARPHA/CRS pools CARICOM markets together and offers a single portal of entry to the region’s 17 million people with one set of internationally recognized standards, and accelerated and transparent timelines. It is a major improvement over the current status quo in regulation of medicines, where products can take years to receive approval in the different national systems of CARICOM.

The list of recommended products is growing by the month and can be found here.

 For more information go to http://carpha.org/what-we-do/laboratory-services-and-networks/crs

 
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Chile: Presencia de partículas Cloxinato de Lisina Solución inyectable 100 mg/2 ml

Alerta Farmacéutica 2/19 – Retiro del Mercado

Clonixinato de Lisina Solución Inyectable 100mg/2 mL. (analgésico, antiinflamatorio no esteroidal (Aines)

Serie 75MH1541 – 75ML2081.

Fecha de vencimiento: 08/2021 – 11/2021

Fabricante: Laboratorio Sanderson S.A/Chile

Descripción del defecto: Presencia de partículas, cuyo origen se encuentra en estudio.

más informaciones por el enlace http://www.ispch.cl/sites/default/files/comunicado/2019/02/19-02-2019%20-%20Presencia%20de%20partículas%20clonixinato%20de%20lisina…..pdf

 
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México avança na compra consolidada de vacinas e medicamentos

Foi montado uma mesa de análise para discutir a participação do México nos Fundos Rotatório e Estratégico da OPAS / OMS.

Como membro ativo das Organizações Pan-Americanas e de Saúde Mundial da OPAS / OMS, o México busca a compra direta de certas vacinas e medicamentos por meio de fundos rotário e estratégico dessa organização internacional, dos quais obteria benefícios com relação aos preços oferecidos.

Mais informações pelo link https://www.gob.mx/cofepris/articulos/mexico-avanza-en-compra-consolidada-de-vacunas-y-medicamentos-186105?idiom=es

 

 
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ANVISA: Uso de mercúrio está proibido em produtos para saúde

Proibição passou a vigorar a partir de 1º de janeiro de 2019. Medida é resultado da convenção de Minamata.

Está proibida a fabricação, importação e comercialização dos termômetros e medidores de pressão que utilizam coluna de mercúrio para diagnóstico em saúde. A medida também inclui a proibição de uso desses equipamentos em serviços de saúde, que deverão realizar o descarte dos resíduos sólidos contendo mercúrio, conforme as normas definidas pela Anvisa (Resolução de Diretoria Colegiada – RDC 306/2004) e Órgãos Ambientais (Federal e Estadual).

A medida foi definida pela Resolução de Diretoria Colegiada – RDC 145/2017, e entrou em vigor nesta terça-feira (1/1). A proibição dos termômetros e dos esfigmomanômetros, como são chamados tecnicamente os medidores de pressão, com coluna de mercúrio, é resultado da Convenção de Minamata. A convenção foi assinada pelo Brasil e mais 140 países em 2013 e tem como objetivo eliminar o uso de mercúrio em diferentes produtos como pilhas, lâmpadas e equipamentos para saúde, entre outros.

Mais informações pela página web da ANVISA

 
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New revision of WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory systems

The GBT Revision VI replaces all tools previously used by WHO, representing the first truly ‘global’ tool for benchmarking regulatory systems. The GBT is designed to evaluate the overarching regulatory framework and the component regulatory functions (e.g. clinical trial oversight) through a series of sub-indicators that may also be grouped and examined according to nine cross-cutting categories or themes, for example, quality and risk management system. Fact sheets have been developed for each sub-indicator to guide the benchmarking team and ensure consistency in the evaluation, documentation and rating of the sub-indicator.

The GBT also incorporates the concept of ‘maturity level’ or ML (adapted from ISO 9004), allowing WHO and regulatory authorities to assess the overall ‘maturity’ of the regulatory system on a scale of 1 ( existence of some elements of regulatory system) to 4 (operating at advanced level of performance and continuous improvement). Revision VI of the GBT is comparable to Revision V while at the same time incorporating refinements intended to improve its usability.

WHO intends to use Revision VI of the GBT to evaluate and publicly designate WHO-listed authorities (WLAs) that have been objectively documented to perform at ML 3 or ML 4*. The proposed definition for WLAs and process by which this designation or ‘listing’ would occur will be the subject of a concept note that will be made available for public consultation in early 2019.

GBT Revision VI was developed to benchmark the regulatory systems for medicines and vaccines, but with a view to incorporating other product types in the future. Future revisions are expected to address blood products (including whole blood, blood components and plasma-derived medicinal products) and medical devices, including diagnostics. Beta versions of these tools have been developed and are expected to be finalized in 2019.

For more information go to https://www.who.int/medicines/regulation/benchmarking_tool/en/

 
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High Blood Pressure and Cancer Medicines on CARPHA Caribbean Regulatory System Recommendation List

The Caribbean Regulatory System (CRS) recently recommended its first non-communicable disease (NCD) medicines, including amlodipine for high blood pressure and anastrozole for breast cancer. The Caribbean is the worst affected sub-region in the Americas for NCDs, which are a leading cause of premature mortality, making up about half of all deaths of people under 70.

The recommended medicines are some of the most important tools that health providers and patients have to correct dangerous conditions like high blood pressure and cancer. For example, amlodipine is recognized as a critically effective blood pressure lowering medicine and is one of the most highly purchased products in the sub-region. Anastrozole is a key treatment in breast cancer and is listed on the World Health Organization’s (WHO) list of essential medicines.

Commenting on the development Dr. Virginia Asin-Oostburg, Director of Surveillance, Disease Prevention and Control at CARPHA who manages the CRS programme said, “This marks an important new milestone for assuring quality NCD medicines in the region, where we know regulatory capacity can be limited due to small populations and few human resources.“  She further noted that each medicine has to be pre-approved by a strong regulatory authority like the United States Food and Drug Administration or the World Health Organization, and be suitable for the Region, before it can be recommended by the CRS to CARICOM member states.

There are more NCD medicines under review at the CRS, and a goal of the program is to have recommended quality versions of all NCD medicines listed on WHO’s list of essential medicines.

Source: http://carpha.org/What-We-Do/Laboratory-Services-and-Networks/CRS