Updates | ClinRegs

India: ICMR Issues Guidelines for EC Review during COVID-19 Pandemic

May 11, 2020 - On May 6, 2020, the Indian Council of Medical Research (ICMR) posted National Guidelines for Ethics Committees Reviewing Biomedical & Health Research during COVID-19 Pandemic. The guidelines cover general ethical issues, review procedures for both COVID-19 related and non-COVID related ...

Uganda Profile Updated in ClinRegs

May 6, 2020 - The Uganda profile in ClinRegs has been reviewed and updated to reflect current regulatory requirements. Key updates include: The new Guidelines on Good Clinical Practice in the Conduct of Trials Involving Human Participants (See Regulatory Authority, Clinical ...

Brazil: ANVISA and CONEP Issue Updated Requirements Related to COVID-19 and Clinical Trials

May 5, 2020 - On April 22, 2020, Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) issued an updated technical note providing guidance to sponsors, centers, and researchers related to clinical research and COVID-19. The note ...

Mexico: COFEPRIS Issues Communication for Clinical Trials during COVID-19 Pandemic

Apr 30, 2020 - On April 21, 2020, the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios) (COFEPRIS)) issued a communication about ensuring the safety of clinical trial participants during the COVID-19 pandemic. ...

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 ...