Washington DC, 22 de noviembre de 2022 (OPS)– Los días 7, 8 y 9 de noviembre de 2022 se llevó a cabo el XIII Encuentro Regional de la Red de Evaluación de Tecnologías en Salud de las Américas (RedETSA) en la ciudad de Brasilia, Brasil. Representantes de 18 países debatieron sobre el proceso de evaluación de tecnologías sanitarias (ETS) en todas las etapas del ciclo de vida de las tecnologías, para afrontar los retos de su incorporación en los sistemas de salud. El evento se organizó en conjunto al III Congreso de la Red Brasilera de Evaluación de Tecnologías en Salud (Rebrats). 
 
Participaron de la apertura del evento Marcelo Queiroga, Ministro de Salud de Brasil; Socorro Gross Galiano, Representante de la oficina de país de OPS/OMS en Brasil;  Sandra Barros,   secretaria de ciencia, tecnología, innovación e insumos estratégicos en salud; Vania Canuto, directora del Departamento de gestión e incorporación de tecnologías en salud; y Alexandre Lemgruber, asesor regional en gestión de tecnologías sanitarias de la OPS.
 
Como parte del Encuentro, se desarrollaron jornadas científicas abiertas y organizadas conforme a las diferentes etapas del ciclo de vida de las tecnologías sanitarias (regulación-evaluación-incorporación-uso-monitoreo). Participaron 311 personas de manera presencial y 228 personas de forma virtual gracias a la transmisión directa del evento. 

Mayores informaciones disponibles por el enlace https://www.paho.org/es/noticias/22-11-2022-xiii-encuentro-regional-red-evaluacion-tecnologias-salud-americas

Washington, DC, 21 de diciembre de 2022 (OPS) – En un esfuerzo por aumentar el acceso equitativo a los tratamientos para la COVID-19, la Organización Panamericana de la Salud (OPS) entregó más de 11.000 viales de un medicamento para mejorar el tratamiento de pacientes gravemente enfermos de COVID-19 en 15 países de América Latina y el Caribe. 

El medicamento, tocilizumab, ha demostrado reducir la mortalidad en pacientes hospitalizados con COVID-19 grave o crítico, que se deterioran rápidamente o necesitan mayores niveles de oxígeno, y que tienen una respuesta inflamatoria significativa.  

La compra, con valor de más de 2 millones de dólares, fue realizada por la OPS con el apoyo del Gobierno de Estados Unidos.

Fuente:

https://www.paho.org/es/noticias/21-12-2022-ops-pone-tratamiento-para-covid-19-disposicion-16-paises

Geneva, 23 January 2023 – WHO is releasing an urgent call to action to countries to prevent, detect and respond to incidents of substandard and falsified medical products.
Over the past four months, countries have reported on several incidents of over-the-counter cough syrups for children with confirmed or suspected contamination with high levels of diethylene glycol (DEG) and ethylene glycol (EG). The cases are from at least seven countries, associated with more than 300 fatalities in three of these countries. Most are young children under the age of five. These contaminants are toxic chemicals used as industrial solvents and antifreeze agents that can be fatal even taken in small amounts, and should never be found in medicines.
Based on country reports, WHO has issued three global medical alerts addressing these incidents. The  Medical Product Alert N°6/2022 on 5 October 2022 focused on the outbreak in the Gambia, Medical Product Alert N°7/2022 on 6 November 2022 focused on Indonesia, and Medical Product Alert N^o1/2023 on 11 January 2023 focused on Uzbekistan.
WHO’s medical product alerts were rapidly disseminated to the national health authorities of all 194 WHO Member States.  These medical product alerts requested, inter alia: (a) the detection and removal of contaminated medicines from circulation in the markets, (b) increased surveillance and diligence within the supply chains of countries and regions likely to be affected, (c) immediate notification to WHO if these substandard products are discovered in-country; and otherwise inform the public of the dangers and toxic effects of the substandard medicines at issue.
Since these are not isolated incidents WHO calls on various key stakeholders engaged in the medical supply chain to take immediate and coordinated action.

For more information go to WHO urges action to protect children from contaminated medicines

FDA’s curriculum materials are intended to help educate students in health care professional degree programs, for medicine, nursing, physician assistants, and pharmacy, as well as practicing professionals, to improve understanding of biosimilar and interchangeable biosimilar products and the regulatory approval pathway in the United States. For more information go to https://www.fda.gov/drugs/biosimilars/curriculum-materials-health-care-degree-programs-biosimilars

https://www.paho.org/es/noticias/10-12-2021-autoridades-reguladoras-nacionales-desempenaran-papel-clave-intensificacion

https://www.paho.org/es/eventos/x-conferencia-panamericana-para-armonizacion-reglamentacion-farmaceutica

Informação disponível em espanhol e em inglês.

X CPARF 6, 8 y 10 diciembre del 2021 – AUDIO ORIGINAL

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Call for expression of interest to contribute to the value chain and supply of reagents for the sustainable manufacturing of a COVID-19 and other mRNA vaccines in the Americas [Deadline extension from 17 September to ​​​​​​​15 October 2021]

 

For the successful establishment of mRNA vaccine manufacturing capacity globally, the World Health Organization (WHO) has launched a new initiative to support transfer of technology to produce mRNA vaccines in low- and middle-income countries (LMICs) (1). The initiative will ensure that all WHO regions will be able to produce vaccines as essential preparedness measure against future infectious threats.

Under this initiative, WHO and the Pan American Health Organization (PAHO) are working together to establish mRNA vaccine manufacturing capacities in LAC. Currently, there is a limited number of global manufacturers able to supply all necessary reagents and/or starting materials (2) needed for manufacturing mRNA vaccines. To ensure sustainability and independence of vaccine production in the Region, access to reagents that are critical to the value chain is fundamental. Hence PAHO/WHO is launching a call for expression of interest to manufacturers in the Region of the Americas that wish to become part of a regional consortium that will ensure that mRNA vaccines can be sourced from starting materials and preparations (including seed lots, cell banks and intermediates) to the finished product.

Through this new initiative, PAHO and WHO will facilitate the establishment of a Regional consortium and support of a comprehensive technology transfer.  Ideally, the group of manufacturers that come together for this initiative will include representatives from different geographical areas in the Americas and work towards an integrated regional value chain that will provide sustainability and ease the dependence on imported vaccines from outside the Region.

To support this activity, we are seeking expressions of interest from:

• Public or private manufactures of medical products (drugs, vaccines or drug substances) , and/or starting materials from the Region of the Americas, which could manufacture and supply one or more of the following:
  • DNAse 1,
  • T7 RNA Polymerase,
  • RNase inhibitor,
  • Guanyl Transferase,
  • Pyrophosphatase,
  • GTP,
  • s-adenosyl methionine, and
  • ribonucleotides.

Entities willing to be considered are invited to provide a brief summary that includes, at a minimum, the reagents and/or starting materials they wish to provide, a summary of their capacity, needs, and their interest in participating in this initiative.

Deadline submission

Deadline extension from 17 September to 15 October 2021

This information must be sent to:

MT@paho.org

 

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(1). See Call for expression of interest to: Contribute to the establishment of a COVID-19 mRNA vaccine technology transfer hub (who.int)

(2). In accordance with WHO TRS Sixty-sixth report starting materials are: any substances of a defined quality used in the production of a pharmaceutical product but excluding packaging materials. In the context of biological products manufacturing, examples of starting materials may include cryo-protectants, feeder cells, reagents, growth media, buffers, serum, enzymes, cytokines, growth factors and amino acids.

 

Source: https://www.paho.org/en/news/25-8-2021-call-expression-interest-contribute-value-chain-and-supply-reagents-sustainable