Updates | ClinRegs

China Profile Updated in ClinRegs

Jul 7, 2020 - The China profile in ClinRegs now includes the National Medical Products Administration’s (NMPA) revised Measures for the Administration of Drug Registration, which took effect July 1, 2020. Please note that NMPA has also released the following requirements which took ...

Peru: INS Issues Guidelines for Clinical Trials during COVID-19 Emergency

Jul 7, 2020 - On June 26, 2020, Peru’s National Institute of Health (Instituto Nacional de Salud (INS)) issued Guidelines for the Conduct of Clinical Trials during the Health Emergency Due to COVID-19. The guidelines aim to assist sponsors in assuring the safety of trial participants, maintaining ...

Liberia Profile Reviewed

Jul 2, 2020 - The Liberia profile in ClinRegs has been reviewed to ensure all information is up-to-date and accurate. ...

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 ...