Updates | ClinRegs

Kenya Profile Updated in ClinRegs

Jun 26, 2020 - The Kenya profile in ClinRegs now includes the following updates: Amendments to the Pharmacy and Poisons Act, enacted through the Health Laws (Amendment) Act, 2019 (See Regulatory Authority and Investigational Products topics) An updated version ...

Brazil: ANVISA Issues Updated Guidelines Related to COVID-19 and Clinical Trials

Jun 25, 2020 - On June 15, 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 ...

South Africa Profile Updated in ClinRegs

Jun 19, 2020 - With this South Africa update, the NIAID ClinRegs Team pays tribute and honors the memory of our friend and collaborator, Gita Ramjee, who passed away in March. Gita directed the South Africa Medical Research Council clinical trials unit in Durban for many years. She had a tremendous passion ...

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 ...