COVID-19 - Regulatory Guidelines

The Regulatory authorities around the globe published guidelines for Clinical Trials management in the light of COVID-19 pandemic.

Visit below the RA links to some countries in North and Latin America:

USA - FDA

https://www.fda.gov/media/136238/download

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic

Canada – Health Canada

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/management-clinical-trials-during-covid-19-pandemic.html

Brazil – ANVISA

http://portal.anvisa.gov.br/documents/2857848/5583613/NT+pesquisa+cl%C3%ADnica+Covid+-+19.pdf/924af08a-21e0-4025-b001-06dae6f6344b

http://portal.anvisa.gov.br/documents/219201/4340788/SEI_ANVISA+-+0989653+-+Nota+T%C3%A9cnica14.pdf/6b48273f-550f-4761-8ba1-4e731a87b526

https://drive.google.com/file/d/1BxMew-CIKs4R68YNPUvSHsaSOBIsrKoI/view

http://portal.anvisa.gov.br/coronavirus

Colombia – INVIMA

https://www.invima.gov.co/web/guest/lineamientos-para-la-presentacion-y-evaluacion-de-estudios-para-covid-19?redirect=%2Farticulos-de-interes-coronavirus-covid-19

Argentina – ANMAT

https://www.argentina.gob.ar/noticias/medidas-y-recomendaciones-en-los-estudios-de-farmacologia-clinica-durante-la-pandemia-covid

Mexico – Secretary of Health

http://dof.gob.mx/nota_detalle.php?codigo=5591417&fecha=09/04/2020

https://www.gob.mx/cms/uploads/attachment/file/547527/Medidas_extraordinarias_Estudios_Cl_nicos_210420.pdf

Peru – INS

https://ensayosclinicos-repec.ins.gob.pe/otros-repec/comunicados/309-comunicado-n-002-2020-ogitt-ins

Chile

http://www.ispch.cl/sites/default/files/Estudios%20Clinicos_Informativo.pdf

OMS

https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports