Updates | ClinRegs

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 ...

Thank You ClinRegs Country Experts

Dec 18, 2020 - As 2020 comes to a close, we would like to thank the country experts who have helped keep ClinRegs up to date over the last year. The people and organizations named here voluntarily provided details on new requirements, reviewed lists of sources, and answered questions so we could ...

Vietnam Profile Updated in ClinRegs

Dec 15, 2020 - The Vietnam profile in ClinRegs has been reviewed and updated where appropriate to reflect current regulatory requirements including: Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (Vietnamese): ...

UK Profile Updated in ClinRegs

Dec 8, 2020 - The United Kingdom profile in ClinRegs has been updated with the following information: The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (No. 744), which allows new guidance documents to come into force post-Brexit on January 1, 2021 ...

Peru Profile Updated in ClinRegs

Nov 20, 2020 - The Peru profile in ClinRegs has been updated with the following information: Ministerial Resolution No. 233-2020, which requires all ethics committees that conduct human health research to register with the National Institute of Health (Instituto Nacional de Salud ...