Updates | ClinRegs

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 ...

UK: Brexit Update and Related MHRA Guidance

Dec 30, 2020 - As of December 24, 2020, the UK and the European Union (EU) have reached a post-Brexit trade agreement. It is unlikely that the deal will be formally ratified before the transition period ends and Brexit comes into full force on January 1, 2021. See this website for more details about ...

Liberia Profile Updated in ClinRegs

Dec 23, 2020 - The Liberia profile in ClinRegs has been updated to include the University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE IRB)’s revised Policies and Procedures Handbook. The updated handbook has been significantly revised ...

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

Dec 22, 2020 - On December 17, 2020, Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) issued RDC nº 449 of 12/15/2020, which amends Articles 38 and 71 of ResolutionNo9 of February 20, 2015. Article 38 now allows for the sponsor to provide ...