Updates | ClinRegs

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 ...

Canada Profile Updated

Jun 16, 2023 - The Canada profile in ClinRegs has been reviewed and updated with the following information: Updated version of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2) (2022) (See Scope of Review, Personal Data Protection, Documentation Requirements, and ...

Brazil Profile Updated with Extended Validity Dates for Certain ANVISA Regulations

Jun 2, 2023 - The Brazil profile in ClinRegs has been updated to include extended validity dates for National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) regulations related to the review and submission of clinical trial applications that were enacted during the COVID-19 ...

Vietnam Profile Updated

May 25, 2023 - The Vietnam profile in ClinRegs has been reviewed and updated as follows: Revision of information on clinical trial phase exemption criteria (See Scope of Assessment) Reorganization of the information included in Scope of Assessment, Scope of Review, and Risk & Quality Management Inclusion ...