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 (…)


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


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


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


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.



El Salvador un modelo en regulación de medicamentos para la región centroamericana.

La Directora Nacional de Medicamentos, Dra. Leonor Morales de Acosta presentó el informe de rendición de cuentas correspondiente al periodo de junio de 2017 a mayo de 2018, en el que resalta importantes logros.

La Dra. de Acosta, destacó  que ahora  El Salvador  tiene un mercado de medicamentos de calidad y  a  precios justos,  asimismo  informó que el mercado  se ha dinamizado con el registro de más de 6 mil nuevos medicamentos lo que garantiza el abastecimiento y la disponibilidad de más opciones terapéuticas para los pacientes.

“Otro logró sin precedentes para la región centroamericana ha sido la regulación de precios de venta al público, El Salvador  ahora tiene los precios más bajos de la región, consecuentemente la población se ha ahorrado una importante cantidad de dinero, en estos 6 años el ahorro en el bolsillo ha sido cerca de 500 millones de dólares”, expresó la titular de la DNM.

Más informaciones por el enlace


Constituido el Grupo Regulador para la contención de la resistencia antimicrobiana en Cuba

El 19 de diciembre del 2018 tuvo lugar en el CECMED el taller de inicio de recogida de información del estudio de prevalencia puntual de uso de antimicrobianos, dentro del Proyecto OMS/OPS “Iniciativa de las Agencias Reguladoras Nacionales de medicamentos para la contención de la resistencia antimicrobiana en el marco de los planes regional y global sobre el tema”.

En el mismo participaron los investigadores de hospitales incluidos en dicha investigación, especialistas del CECMED y de la Coordinación OPS Cuba. El encuentro tuvo como objetivos actualizar a los participantes sobre la puesta en marcha del proyecto e instruir a los investigadores en la metodología propuesta para la recolección de la información.

Más informaciones por el enlace


IX Conferencia da Rede Pan-Americana para a Harmonização das Autoridades Reguladoras de Medicamentos (CPARF)

– 35 países estão reunidos em El Salvador para a troca de conhecimento e experiência na regulamentação farmacêutica.

– Direção Nacional de Medicamentos, em coordenação com a Organização Pan-Americana da Saúde (OPAS) e da Organização Mundial da Saúde (OMS), realizada de 24 a 26 de outubro de 2018, a Conferencia da Rede Pan-Americana para a Harmonização das Autoridades Reguladoras de Medicamentos (CPARF) onde todos os países das Américas participem.


Esta é a primeira vez que um país da América Central está hospedando uma reunião deste nível em que as estratégias regulamentares para medicamentos e dispositivos médicos são discutidos visando a melhoria da qualidade dos cuidados de vida e de saúde aos cidadãos de países membros da Americas.

O objetivo desta reunião é a troca de conhecimento e experiência na regulamentação farmacêutica para promover a ação para a saúde da população. Através da cooperação entre os países da América podem reforçar as medidas reguladoras para garantir que os doentes tenham acesso a medicamentos seguros, eficazes e de qualidade.

A CPARF é um fórum continental coordenado pela OPAS / OMS onde as autoridades reguladoras de medicamentos, representantes da indústria nacional e internacional farmacêutico, acadêmicos e representantes de associações de profissionais de saúde envolvidos.

Os principais tópicos a serem discutidos nesta reunião incluem: atividades de resistência antimicrobiana e controle, regulação na promoção do acesso e cobertura universal da saúde, os desafios atuais da regulamentação de produtos médicos na região, o reforço dos sistemas de regulação na região: o impacto dos programas globais para fortalecer os sistemas de regulamentação, o acesso a medicamentos e outras tecnologias essenciais.


Mais informações pelo link



The FDA Adverse Event Reporting System (FAERS) Public Dashboard

The FAERS Public Dashboard is a highly interactive web-based tool that will allow for the querying of FAERS data in a user friendly fashion. The intention of this tool is to expand access of FAERS data to the general public to search for information related to human adverse events reported to the FDA by the pharmaceutical industry, healthcare providers and consumers.

What is FAERS?

The FDA Adverse Event Reporting System (FAERS) is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that were submitted to FDA. The database is designed to support the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. The informatic structure of the FAERS database adheres to the international safety reporting guidance issued by the International Conference on Harmonisation (ICH E2B). Adverse events and medication errors are coded using terms in the Medical Dictionary for Regulatory Activities (MedDRA) terminology.

For more information go to