Updates | ClinRegs

Thailand FDA Issues Guidelines for Clinical Trials During COVID-19 Outbreak

Jun 12, 2020 - On May 26, 2020, Thailand's Food and Drug Administration issued guidance to sponsors and investigators regarding the conduct of clinical trials during the COVID-19 outbreak. The guidelines provide examples of flexible approaches to ensure participant safety while still complying with ...

Peru: INS Resumes Administrative Procedures

Jun 2, 2020 - On May 6, 2020, Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) issued Communique 004-2020-OGITT/INS, which notes that the administrative procedures suspended by Communique 003-2020-OGITT/INS have been resumed. All procedures related to ...

Vietnam Profile Updated in ClinRegs

May 13, 2020 - The Vietnam profile in ClinRegs has been reviewed to ensure all information is up-to-date.

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. ...