CDERLearn in the Center for Drug Evaluation and Research (CDER) offers a variety of learning opportunities for healthcare professionals, industry, consumers, and academia. The goal is to create a body of educational and information modules about human drug regulation and activities. CDERLearn is a way to share FDA expertise in specific subject areas to further instruct the public about the many ways CDER protects and promotes public health.

For more information go to https://www.fda.gov/training-and-continuing-education/cderlearn-training-and-edu

Belize began registering medicines as a result of the Food and Drugs (Registration, Licensing and Inspection) Regulations passed in 2017,  and the products that are listed are new to the country. Previously imported medicines that were available in the market prior to the new regulations were grandfathered into the system while ensuring its safety, efficacy and quality. The publication of a list of registered medicines is a best practice in transparency and accountability of regulatory systems as recommended by PAHO/WHO. Among the many benefits, it helps to provide the public and other stakeholders with visibility over what is legally approved to be sold in the market. Other countries in the CARICOM block can look to Belize as an important leader in this area.

For more information go to: http://health.gov.bz/www/units/drug-inspectorate-unit/drug-registration/989-new-drugs-registered-2017-2019

CARPHA’s Caribbean Regulatory System (CRS) recently recommended its 40th medicine to CARICOM governments. “This is an important milestone for the CRS because it shows that manufacturers are increasingly using the system and it can work” said Dr. Virginia Asin, who oversees the program as the Director, Surveillance, Disease Prevention and Control at CARPHA. The updated list of recommended medicines is publicly available on CARPHA’s webpage. 

The CRS assists the small states of CARICOM with the resource- and time-intensive task of evaluating medicines for safety, quality, and efficacy. Its approach requires that all medicines reviewed are already approved by a PAHO-designated reference authority, the European Union, or WHO Prequalification program. Once confirmed as eligible, the medicines intended for the CARICOM markets are verified as the same. Internal data show that the medicines available in highly regulated markets are not necessarily the same products that are sold in CARICOM.

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

Como cada año, el Día Mundial del Donante de Sangre se celebrará en todo el mundo el 14 de junio. Este evento sirve para dar las gracias a los donantes voluntarios no remunerados por un regalo que permite salvar vidas, así como para concienciar de la necesidad de hacer donaciones regulares para tener acceso oportuno y asequible a sangre y productos sanguíneos seguros y de calidad, como parte integral de la salud universal y componente fundamental de los sistemas de salud eficaces.

El tema de la campaña de este año es la donación de sangre y el acceso universal a las transfusiones de sangre segura, como elemento para lograr la salud universal. Hemos adoptado el lema «Sangre segura para todos» para sensibilizar sobre la necesidad universal de sangre segura en la prestación de atención de salud y la función esencial que desempeñan las donaciones voluntarias en la consecución del objetivo de la cobertura sanitaria universal. El tema tiene por objeto alentar vivamente a más personas en todo el mundo a convertirse en donantes y a hacer donaciones regulares, acciones que constituyen la piedra angular para crear una base sólida para establecer un suministro de sangre sostenible a nivel nacional que permita atender a las necesidades de transfusión de todos las personas.

El anfitrión de los eventos del Día Mundial del Donante de Sangre – 2019

• El país anfitrión del evento del Día Mundial del Donante de Sangre 2019 es Rwanda.
• El país anfitrión en la Región de las Américas es Costa Rica.

Más informaciones disponibles por el enlace https://www.paho.org/hq/index.php?option=com_content&view=article&id=15148:safe-blood-for-all-14-june-2019&Itemid=39594&lang=es

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

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

Entérate de las últimas noticias del Departamento de Sistemas y Servicios de Salud de la OPS y conoce nuestros proyectos y avances hacia el acceso universal a la salud y cobertura universal de salud en la Región de las Américas.

https://us4.campaign-archive.com/?u=487855692ac2aa91b795e38af&id=1f1465ac68 

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

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