Updates | ClinRegs

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 ...

Brazil Profile Updated

Apr 12, 2023 - The Brazil profile in ClinRegs has been reviewed and updated with the following information: National Health Council (Conselho Nacional de Saúde (CNS)) regulation from 2022 providing review criteria and timelines to classify research and process protocols in the institutional ethics ...

UK Profile Updated with Revised MHRA Fees

Apr 7, 2023 - The United Kingdom profile in ClinRegs has been updated to include the revised fee schedule for clinical trials, which was issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) on April 1, 2023 (See Regulatory Fees). Sources Revised During this ...

China Profile Updated to Include New NMPA Guidelines

Apr 6, 2023 - The China profile in ClinRegs has been updated to include the following guidelines issued by the National Medical Products Administration (NMPA) in March 2023: New guidance regarding the Phase III pre-clinical trial meeting with the Center for Drug Evaluation when ...