Updates | ClinRegs

South Africa: SAHPRA Revises GCP Training Requirements and Issues Clinical Trial Application Guidance for Public Health Emergencies

Apr 16, 2020 - On April 13, 2020, the South African Health Products Regulatory Authority (SAHPRA) issued GCP Training and Expedited Review of Clinical Trial Applications during COVID-19 Pandemic. The notice states that SAHPRA has amended requirements for in-person good clinical practice (GCP) training ...

Brazil: ANVISA Issues Notice for Clinical Trials Impacted by COVID-19

Apr 2, 2020 - On March 23, 2020, the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) issued a technical note providing guidance to sponsors, centers, and researchers on the conduct of clinical research and bioequivalence studies that may ...

India Profile Updated in ClinRegs

Apr 1, 2020 - The India profile in ClinRegs has been reviewed and updated to reflect current regulatory requirements. Key updates include: Additional checklists and FAQs issued by the Central Drugs Standard Control Organization (CDSCO) to facilitate the clinical trial application ...

Peru: INS Issues Communications for Clinical Trials Impacted by COVID-19

Apr 1, 2020 - Due to the COVID-19 outbreak, Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) has issued the following communications: Communique 003-2020-OGITT/INS regarding the current suspension of administrative procedures until further notice and the prioritization ...

South Africa: SAHPRA Issues Guidance for Clinical Trials Impacted by COVID-19

Mar 27, 2020 - On March 25, 2020, the South African Health Products Regulatory Authority (SAHPRA) issued SAHPRA Policy on Conduct of Clinical Trials of Health Products during the Current COVID-19 Pandemic. The guidance covers items such as participant safety, maintaining compliance with good clinical ...

Health Canada Issues Notice for Clinical Trials Impacted by COVID-19

Mar 24, 2020 - On March 23, 2020, Health Canada issued Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors, which provides information related to protocol deviation, participant safety, site monitoring, participant eligibility, pausing a study, and shipment of ...

Australia: Health Agencies Issue Joint Guidance Regarding Clinical Trials and COVID-19

Mar 24, 2020 - On March 24, 2020, Australia’s state and territory Departments of Health, the Therapeutic Goods Administration (TGA), National Health and Medical Research Council (NHMRC) and the Clinical Trials Project Reference Group (CTPRG) issued: COVID-19: Guidance on clinical trials for institutions, ...