Updates | ClinRegs

Kenya Profile Updated in ClinRegs

Mar 9, 2021 - The Kenya profile in ClinRegs has been updated to include the following information: Guidelines on Research Licensing and Institutional Affiliation: A National Commission for Science, Technology, and Innovation (NACOSTI) guidance for submitting research license applications, ...

Brazil: ANVISA Issues Notice on Safety Reporting and COVID-19 Clinical Trials

Feb 18, 2021 - On February 11, 2021, Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) issued a notice stating that, due to some instabilities with the online NotivsaEC form, sponsors must also email notifications of unexpected serious adverse ...

China Profile Updated with New Biosecurity Law

Feb 17, 2021 - The China profile in ClinRegs has been updated to include China’s Biosecurity Law, which was enacted in October 2020 and goes into effect on April 15, 2021. The law governs several biosecurity areas, including the collection and management of human genetic resources ...

Tanzania Profile Updated in ClinRegs

Jan 28, 2021 - The Tanzania profile in ClinRegs has been has been updated to include the following information: Tanzania Medicines and Medical Devices Authority’s (TMDA) Regulatory Information Management System (RIMS) Customer Self Service Portal: A new online portal for submitting ...

US Profile Updated in ClinRegs

Jan 20, 2021 - The United States profile in ClinRegs has been reviewed to ensure all information is up to date. The following sources have been added to the profile: Human Subject Regulations Decision Charts (Last Reviewed June 30, 2020) (See Regulatory Authority) Guidance ...

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UK: HRA Launches Fast-Track Ethics Review Pilot

Jan 7, 2021 - On January 4, 2021, the Health Research Authority (HRA) launched the fast-track research ethics review pilot, which will run until March 31, 2021. The pilot aims to test the demand for, and feasibility of a fast-track ethics review service that uses a dedicated ethics committee with expert ...