Updates | ClinRegs

South Africa Profile Updated with the Latest Regulatory Fees

May 28, 2025 - The South Africa profile in ClinRegs has been updated as of March 31, 2025, with the latest information on clinical trial application fees and payment instructions, effective February 13, 2025. (See Regulatory Fees)Sources Added During this Update:(Communication) Newly Gazetted Regulation Regarding ...

United States Profile Updated

May 20, 2025 - The United States profile in ClinRegs has been reviewed and updated with the following information:Information on the Food & Drug Administration (FDA’s) Electronic Submissions Gateway Next Generation (ESG NextGen) platform, which went live on April 14, 2025 (See Submission Process)Department ...

Tanzania Profile Updated

Apr 30, 2025 - The Tanzania profile in ClinRegs has been reviewed and updated with the following information, which is current as of April 3, 2025:2024 guidance from the Tanzania Medicines and Medical Devices Authority (TMDA) on payment procedures for overseas customers (See Regulatory Fees)TMDA regulations ...

Zimbabwe Profile Updated with Cyber and Data Protection Requirements

Apr 14, 2025 - The Zimbabwe profile in ClinRegs has been updated as of March 19, 2025, to include 2024 regulations and guidance on cyber and data protection requirements, including licensing, responsibilities, and consent for children. (See Personal Data Protection)Sources Added During this Update:(Regulation) ...

Uganda Profile Updated

Apr 10, 2025 - The Uganda profile in ClinRegs has been reviewed and updated with the following information, which is current as of March 10, 2025:New details on clinical trial application and review processes and reporting requirements from the 2024 updates of the National Drug Authority (NDA)’s regulation ...

Australia Profile Updated

Apr 9, 2025 - The Australia profile in ClinRegs has been updated with the following information, which is current as of February 5, 2025:Investigational product requirements from the Therapeutic Goods Administration (TGA)’s 2024 adoption of the 2022 PIC/S guide to good manufacturing practice (See Manufacturing ...

Liberia Profile Updated

Apr 8, 2025 - The Liberia profile in ClinRegs has been reviewed and updated with the following information, which is current as of February 4, 2025:Liberia Medicines and Health Products Regulatory Authority (LMHRA)’s 2022 clinical trial regulations, which were incorporated through the profileNational Research ...