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Revista Cubana de Farmacia

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2020, Number 3

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Rev Cubana Farm 2020; 53 (3)

The regulatory approach on the Cuban response against COVID-19

Romeu B, Sánchez C, Rodríguez Y
Full text How to cite this article

Language: Spanish
References: 6
Page: 1-7
PDF size: 392.66 Kb.


Key words:

drug regulation, vaccines, COVID-19, SARS-CoV-2.

ABSTRACT

This short communication has as its fundamental premise to expose the work developed by the Regulatory Agency of Medicines, Equipment and Medical Devices of Cuba, as an integral part of the National Plan for the confrontation of COVID-19. Because there are still no approved therapies, drugs or vaccines from a regulatory perspective, with proven effectiveness and safety for patients, a multi-stakeholder consensus, collaborative and proactive analysis is essential among all strategic sectors of emergency response caused by SARS-CoV-2. The coherent and integrated vision of the regulatory authority's emergency has enabled decision-making and adaptability to the changing context caused by the pandemic.


REFERENCES

  1. Registro Público de Ensayos clínicos. Evaluación de la seguridad y eficacia de BIOMODULINA T® para la prevención de infecciones entre ellas la COVID-19, en adultos mayores en Cuba. Ensayo Clínico Fase IV (COVID-19). Cuba: Registro Público de Ensayos clínicos; 2020 [acceso 12/07/2020]. Disponible en: https://rpcec.sld.cu/ensayos/RPCEC00000310-Sp

  2. CECMED. Esperanza (Heberferón+ Heberón); 2020 [acceso 12/07/2020]. Disponible en: https://www.cecmed.cu/COVID-19/aprobaciones/esperanza-heberferon-heberon

  3. CECMED. Autorización de Uso de Emergencia” (AUE) del producto Jusvinza, a emplearse en el tratamiento de pacientes hospitalizados positivos a la COVID-19, que se encuentren graves o críticos y en los que exista sospecha o se identifique un estado de hiperinflamación. Cuba: CECMED; 2020 [acceso 12/08/2020]. Disponible en: https://www.cecmed.cu/covid-19/aprobaciones/jusvinza-cigb-258-1

  4. Venegas-Rodrigues R, Santana-Sanchez R, Peña-Ruiz R, Bequet-Romero M, Hernandez-Cedeño M, Santiesteban-Licea B, et al. CIGB-258 immunomodulatory peptide: a novel promising treatment for critical and severe COVID-19 patients. medRxiv [Preprint]. 2020. 05.27.20110601. DOI: 10.1101/2020.05.27.20110601

  5. Ramo Suzarte M, Díaz Y, Martín Y, Calderón NA, Santiago W, Vinet O, et al. Use of a humanized anti-CD6 monoclonal antibody (Itolizumab) in elderly patients with moderate COVID-19. [2020] medRxiv [Preprint]. DOI: 10.1101/2020.07.24.20153833

  6. News India. Biocon's Itolizumab Reducing Covid-19 Mortality in Cuba Gets Approval in India: Kiran Mazumdar Shaw. News India. 13 jul. 2020 [actualizado 13/07/2020; acceso 14/07/2020]. Disponible en: https://www.news18.com/news/india/govt-believes-itolizumab-is-an-affordable-drug-to-save-lives-says-biocons-kiran-mazumdar-shaw-2714435.html




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C?MO CITAR (Vancouver)

Rev Cubana Farm. 2020;53