Updates | ClinRegs

Brazil Profile Updated in ClinRegs

Apr 29, 2020 - The Brazil profile in ClinRegs has been reviewed and updated to reflect current requirements and information including: Information on the National Health Surveillance Agency’s (Agência Nacional de Vigilância Sanitária (ANVISA)) new technical review procedures ...

China Profile Updated in ClinRegs

Apr 17, 2020 - The China profile in ClinRegs now includes the following updates: Updated information on implementing the revised Drug Administration Law (See the Regulatory Authority topic) Updated guidance on communication and technical review meetings with the National ...

United States: OHRP Issues Guidance for Research Impacted by COVID-19

Apr 16, 2020 - On April 8, 2020, the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) issued guidance on how HHS human subjects protection regulations (45 CFR part 46) apply to institutional and investigator actions responding to COVID-19. The guidance ...

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 ...