Updates

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

Mar 17, 2026 - The Australia profile in ClinRegs has been 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 Reaction ...

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 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 and Submission ...

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 ...

CAN flag Canada Profile Updated with the Latest Drug Submissions and Applications Guidance

Dec 19, 2025 - The Canada profile in ClinRegs has been updated with the latest version of the Guidance on Management of Drug Submissions and Applications, which took effect on October 1, 2025. (See Regulatory Authority, Submission Process, and Timeline of Review)Sources Revised During this Update:(Guidance) ...

DRC flag DRC Profile Updated

Dec 16, 2025 - The DRC profile in ClinRegs has been reviewed and updated with the following information:Clinical trial application requirements and form for the Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) (See Scope of Assessment, Scope of ...
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