Updates | ClinRegs

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 ...

Uganda Profile Updated in ClinRegs

Nov 13, 2020 - The Uganda profile in ClinRegs has been updated with the following information: Updated Research Clearance Process form for clinical trial approval from the Uganda National Council for Science and Technology (UNCST) (See Regulatory Authority and Clinical ...

New ClinRegs Functionality Enables Easier Access to Source Documents

Nov 13, 2020 - ClinRegs users can now access source documents in the comparison view rather than having to return to the single country view. The full details for each source citation continue to be provided in the single country view.