Updates | ClinRegs

Australia: CTX Scheme Renamed CTA Scheme

Nov 11, 2020 - On November 6, 2020, Australia's Therapeutic Goods Administration (TGA) announced that it has changed the name of the Clinical Trial Exemption (CTX) scheme to the Clinical Trial Approval (CTA) scheme. The name change from CTX to CTA does not involve any process changes, and all ...

China Profile Updated in ClinRegs

Oct 30, 2020 - The China profile in ClinRegs now includes the following updates: Updated contact information for the regulatory authorities (See Regulatory Authority) New online platforms for submitting clinical trial materials (See Regulatory Authority and Submission ...

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 ...