Updates | ClinRegs

Australia Profile Updated with Revised TGA Fee Schedule

Jul 11, 2023 - The Australia profile in ClinRegs has been updated to include the Therapeutic Goods Administration (TGA)'s revised fee schedule, which took effect on July 1, 2023 (See Regulatory Fees). Sources Revised During this Update: (Legislation) Therapeutic Goods Regulations 1990 (Statutory Rules ...

Canada Profile Updated

Jun 16, 2023 - The Canada profile in ClinRegs has been reviewed and updated with the following information: Updated version of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2) (2022) (See Scope of Review, Personal Data Protection, Documentation Requirements, and ...

Brazil Profile Updated with Extended Validity Dates for Certain ANVISA Regulations

Jun 2, 2023 - The Brazil profile in ClinRegs has been updated to include extended validity dates for National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) regulations related to the review and submission of clinical trial applications that were enacted during the COVID-19 ...

Vietnam Profile Updated

May 25, 2023 - The Vietnam profile in ClinRegs has been reviewed and updated as follows: Revision of information on clinical trial phase exemption criteria (See Scope of Assessment) Reorganization of the information included in Scope of Assessment, Scope of Review, and Risk & Quality Management Inclusion ...

Mexico Profile Updated

May 18, 2023 - Mexico Profile Updated The Mexico profile in ClinRegs has been reviewed and updated with the following information: Updated contact information for the Federal Commission for the Protection Against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS))’s ...

South Africa Profile Updated

Apr 26, 2023 - The South Africa profile in ClinRegs has been updated to include the following information: South African Health Products Regulatory Authority (SAHPRA) Clinical Trials Committee meeting and application submission dates for 2023 (See Scope of Assessment, Submission Process, and Timeline ...

Tanzania Profile Updated

Apr 21, 2023 - The Tanzania profile in ClinRegs has been reviewed and updated with the following information: The Tanzania Medicines and Medical Devices Authority (TMDA) six-month progress report form for clinical trials of an investigational product (See Progress Reporting) Information on the TMDA’s ...