Updates | ClinRegs

Zimbabwe Profile Updated

Nov 20, 2025 - The Zimbabwe profile in ClinRegs has been reviewed and updated with the following information, which is current as of November 12, 2025:Medicines Control Authority of Zimbabwe (MCAZ) regulatory fee schedule, which took effect September 1, 2025 (See Regulatory Fees)Updated MCAZ pharmacy guidelines ...

Bangladesh Profile Updated

Nov 19, 2025 - The Bangladesh profile in ClinRegs has been reviewed and updated with the following information, which is current as of October 9, 2025:Updated Directorate General of Drug Administration (DGDA) document regarding the format for clinical trial protocol approval applications (See Scope of Assessment, ...

South Africa Profile Updated with Revised Data Protection Regulations and Related Sources

Nov 18, 2025 - The South Africa profile in ClinRegs has been updated as of October 16, 2025 to include 2025 amended regulations and sources related to the protection of personal information. (See Personal Data Protection)Sources Added During this Update:(Document) ASSAf POPIA Compliance ...

Malawi Profile Updated

Nov 17, 2025 - The Malawi profile in ClinRegs has been reviewed and updated with the following information, which is current as of October 7, 2025:Guidance from the College of Medicine Research and Ethics Committee (COMREC) on the content and format of a research proposal (See Scope of Review, Ethics Committee ...

Australia Profile Updated

Nov 14, 2025 - The Australia profile in ClinRegs has been reviewed and updated with the following information, which is current as of September 30, 2025:New Therapeutic Goods Administration (TGA) webpages containing clinical trial approval (CTA) process information and forms (See Scope of Assessment, Ethics ...

India Profile Updated

Nov 14, 2025 - The India profile in ClinRegs has been reviewed and updated with the following information, which is current as of September 23, 2025:2024 amendment to the New Drugs and Clinical Trials Rules establishing new clinical research organization (CRO) requirements (See Scope of Assessment, Regulatory ...

Brazil Profile Updated with Previously Vetoed Parts of Law No. 14,874

Sep 24, 2025 - The Brazil profile in ClinRegs has been updated to include the previously vetoed parts of Law No. 14,874, of May 28, 2024, one which limits the post-study access program requirement to five (5) years and the other which requires that the Public Prosecutors Office be notified ...