CDERLearn Training and Education

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.

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Belize became the first country in the CARICOM block of countries to publish a list of registered medicines

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.

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40th Medicine Recommended to CARICOM Governments

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.

Because the CRS is voluntary, manufacturers determine the products that they submit, but medicines should be listed on the WHO Essential Medicine List or be of public health value to the region. An increasing percentage of the recommended medicines treat non-communicable diseases (about 25% currently), which make up a large disease burden in CARICOM countries. Other products that are important to public health are included, such as antibiotics and antiretrovirals. The CRS recently recommended an innovative cure and an essential medicine to treat Hepatitis C that is not currently registered anywhere in the region.

The process of review by the CRS typically takes about 6-8 weeks from receipt of documents to decision-making and recommendation to CARICOM governments. This has been found to be much faster than the current timelines in the region. This accelerated processing also enables faster access to essential quality medicines for patients.

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


Sangre segura para todos. 14 de junio del 2019

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.

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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 (…)





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.


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ANVISA: Uso de mercurio está prohibido en productos para la salud

La prohibición pasó a vigor a partir del 1 de enero de 2019. La medida es el resultado de la convención de Minamata.

Está prohibida la fabricación, importación y comercialización de los termómetros y medidores de presión que utilizan columna de mercurio para diagnóstico en salud. La medida también incluye la prohibición de uso de estos equipos en servicios de salud, que deberán realizar el descarte de los residuos sólidos conteniendo mercurio, conforme a las normas definidas por la Anvisa (Resolución de Dirección Colegiada – RDC 306/2004) y Órganos Ambientales (Federal y estatal ).
La medida fue definida por la Resolución de Directorio Colegiado – RDC 145/2017, y entró en vigor el martes (1/1). La prohibición de los termómetros y de los esfigmomanómetros, como se llaman técnicamente los medidores de presión, con columna de mercurio, es el resultado de la Convención de Minamata. La convención fue firmada por Brasil y otros 140 países en 2013 y tiene como objetivo eliminar el uso de mercurio en diferentes productos como pilas, lámparas y equipos para salud, entre otros.

Más información por el enlace 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.

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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.