Updates

ZAF flag South Africa Profile Updated

Mar 19, 2026 - The South Africa profile in ClinRegs has been reviewed and updated with the following information:South African Health Products Regulatory Authority (SAHPRA)’s application requirements from 2025 on proof of insurance (See Insurance & Compensation)SAHPRA safety reporting guidance on the ...

KEN flag Kenya Profile Updated

Mar 19, 2026 - The Kenya profile in ClinRegs has been reviewed and updated with the following information:Minor revisions to the National Commission for Science, Technology and Innovation (NACOSTI)’s research categories for research license application service charges (See Regulatory Fees)Reference to Pharmacy ...

AUS flag Australia Profile Updated with Latest TGA Safety Reporting Email Address

Mar 17, 2026 - The Australia profile in ClinRegs has been reviewed and updated with the latest email address for submitting the blue card adverse reaction reporting form to the Therapeutic Goods Administration (See Safety Reporting).Sources Revised During This Update:(Form) Blue Card Adverse ...

CHN flag China Profile Updated

Mar 9, 2026 - The China profile in ClinRegs has been reviewed and updated with the following information:Reforms and requirements from the National Medical Products Administration (NMPA) and the State Council from 2024 and 2025 on improving the drug review and approval system, including application requirements ...

GBR flag United Kingdom Profile Updated

Feb 18, 2026 - The United Kingdom profile in ClinRegs has been reviewed and updated with the following information:Revised Medicines and Healthcare Products Regulatory Agency (MHRA) fee schedule for clinical trials (See Regulatory Fees)Reference to new IRAS combined review user guide (See Scope of Assessment ...

MLI flag Mali Profile Updated

Jan 23, 2026 - The Mali profile in ClinRegs has been reviewed and updated with the following information:Additional statement related to health inspectors, the Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)), and approved ethics committee (EC) members ensuring compliance ...

GIN flag Guinea Profile Updated

Jan 8, 2026 - The Guinea profile in ClinRegs has been reviewed and updated with the following information:Updated information regarding clinical trial registration requirement (See Initiation, Agreements & Registration)Requirements related to clinical trials involving children (See Children/Minors)Additional ...
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