Updates | ClinRegs

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 ...

Uganda Profile Updated

Mar 22, 2023 - The Uganda profile in ClinRegs has been reviewed and updated with the following information: Uganda National Council for Science and Technology (UNCST) guidelines from 2022 regarding community engagement in research (See Initiation, Agreements & Registration) UNCST correspondence ...

Guinea Profile Updated with Revised DNPM Contact Information

Mar 14, 2023 - The Guinea profile in ClinRegs has been updated to include a link to the National Directorate of Pharmacy and Medicine (DNPM) website and revised contact information. Sources Added During this Update: (Webpage) National Directorate of Pharmacy and Medicine (DNPM) (GIN-2 - ...

Kenya Profile Updated

Mar 3, 2023 - The Kenya profile in ClinRegs has been reviewed and updated with the following information: New regulations and updated guidelines issued in 2022 on the conduct of clinical trials in Kenya (See Regulatory Authority, Clinical Trial Lifecycle, Sponsorship, Informed Consent, and Investigational ...

Peru Profile Updated with Amended Clinical Trial Authorization Procedures

Feb 22, 2023 - The Peru profile in ClinRegs has been updated to include the Headquarters Resolution No. 252-2022-J-OPE/INS, which modifies the clinical trial authorization procedures (section 7.5) in the Manual of Clinical Trials Procedures (MAN-INS-001). Clinical trial applications and accompanying documentation ...