Updates | ClinRegs

Malawi Profile Updated

Aug 25, 2023 - The Malawi profile in ClinRegs has been reviewed and updated as follows: Updated Pharmacy and Medicines Regulatory Authority (PMRA) serious adverse event guidance, clarifying reporting timeline requirements (See Safety Reporting) New PMRA forms for declaration of intent, declarations ...

Liberia Profile Updated

Aug 18, 2023 - The Liberia profile in ClinRegs has been reviewed and updated as follows: Reorganization of the information included in Scope of Assessment, Risk & Quality Management, and Required Elements Addition of Atlantic Center for Research and Evaluation Institutional ...

Zimbabwe Profile Updated

Aug 11, 2023 - The Zimbabwe profile in ClinRegs has been reviewed and updated with the following information: Medicines Control Authority of Zimbabwe (MCAZ) regulatory fees for foreign researchers; updated pharmacy licensing and unregistered medicine import/export fees; and Research Council of Zimbabwe ...

Brazil Profile Updated

Aug 9, 2023 - The Brazil profile in ClinRegs has been updated to remove Resolution of the Collegiate Board - RDC No. 534 of August 23, 2021 and the related Resolution of the Collegiate Board of Directors – RDC No. 799 of May 19, 2023, which extended the validity of RDC No. 534 until July 20, 2023.

Bangladesh Profile Updated

Jul 28, 2023 - The Bangladesh profile in ClinRegs has been reviewed and updated with the following information: Manual containing requirements and recommendations for ethics committees (See Ethics Committee topic) Reorganization of the information included in Scope of Assessment, Ethics Committee, ...

Thailand Profile Updated

Jul 26, 2023 - The Thailand profile in ClinRegs has been reviewed and updated with the following information: Personal Data Protection Committee regulation and related guidelines from 2022 (See Personal Data Protection) Articles providing clarification on 2022 data protection requirements (See Personal ...

Australia Profile Updated with Revised TGA Fee Schedule

Jul 11, 2023 - The Australia profile in ClinRegs has been updated to include the Therapeutic Goods Administration (TGA)'s revised fee schedule, which took effect on July 1, 2023 (See Regulatory Fees). Sources Revised During this Update: (Legislation) Therapeutic Goods Regulations 1990 (Statutory Rules ...