Updates | ClinRegs

Kenya: PPB Issues Guidance for Clinical Trials Impacted by COVID-19

Apr 16, 2020 - Kenya’s Pharmacy and Poisons Board (PPB) has issued Guidance to Sponsors and Investigators for Conduct of Clinical Trials during the COVID-19 Pandemic in Kenya, which takes effect April 20, 2020. The guidance addresses the following topics: Management of and amendments to existing ...

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 ...