China’s NMPA introduces new guidance for COVID-19 drug clinical trials

China’s National Medical Product Administration (NMPA) released on July 2020 a guideline focused on the emergency approval of the new COVID-19 virus drugs and vaccines for sponsors and researchers.

Brazil’s Anvisa publishes Service Orientation (OS) that may provide simplification of clinical trial applications (DDCM)

Anvisa pusblishes Service Orientation (OS) 88/2020 provides details on procedures for reviewing documents required for submission of the Clinical Drug Development Dossier (DDCM) and changes that potentially impact the quality or safety of experimental drugs, active BE drugs or placebos.

The Office of Human Research Protection Issues Guidance on the Conduct of Clinical trials During COVID-19

On April 8, 2020 the USA’s Office of Human Research Protections (OHRP) released a guidance on  Human Subject Protection Regulations included under regulation 45 CRF part 46, which applies to COVID-19 response. 

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