Updates | ClinRegs

Mexico Profile Updated in ClinRegs

Oct 23, 2020 - The Mexico profile in ClinRegs has been reviewed and updated to reflect current regulatory requirements. Key updates include: New guidance for clinical trial applicants on submitting research protocols (See the Clinical Trial Lifecycle topic) Amended fees ...

Australia Profile Updated in ClinRegs

Oct 15, 2020 - The Australia profile in ClinRegs has been reviewed and updated to reflect current requirements, including: New contact details for the Therapeutic Goods Administration (TGA) (See Regulatory Authority) The updated Clinical Trial Notification (CTN) form user ...

Brazil: ANVISA Publishes New Clinical Trial Guidance Documents and Transitions to New Website

Oct 2, 2020 - On September 29, 2020, Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) website migrated to the following new URL: https://www.gov.br/anvisa. For more details regarding the migration, please see this notice. On September 11, ...

Sierra Leone Profile Reviewed

Sep 30, 2020 - The Sierra Leone profile in ClinRegs has been reviewed. All information is up-to-date and accurate. Should any of Sierra Leone's requirements undergo revision, we will make the corresponding updates in ClinRegs and notify you promptly.

Liberia: UL-PIRE IRB Issues Updated Handbook

Sep 21, 2020 - The University of Liberia-Pacific Institute for Research and Evaluation Institutional Review Board (UL-PIRE IRB) has revised their Policies and Procedures Handbook as of June 2020. The comprehensively revised handbook, which replaces the 2008 version, provides information ...

Vietnam: Recent COVID-19 and Other Clinical Trials Requirements Issued by MOH

Sep 10, 2020 - Vietnam's Ministry of Health (MOH) recently issued the following requirements: COVID-19 Decision Decision No. 3659/QD-BYT (August 21, 2020) -- guides research, clinical trials, registration for circulation, and use of the COVID-19 vaccine. Of note, this Decision reinforces the ...

United Kingdom: MHRA Issues Guidance for Clinical Trials Post-Brexit Transition Period

Sep 1, 2020 - On September 1, 2020, the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) issued the following guidance documents related to clinical trials after the Brexit transition period ends on December 31, 2020: Registration of clinical trials for investigational ...