Updates | ClinRegs

Australia Profile Updated in ClinRegs

Dec 17, 2021 - The Australia profile in ClinRegs has been reviewed and updated to ensure all information and sources are up-to-date and accurate. While there were no substantial edits to the summary text, some sources were added to the profile to provide supplementary information. Sources Added During ...

Brazil Profile Updated

Dec 8, 2021 - The Brazil profile in ClinRegs has been updated with the following information: RDC No. 573 of October 29, 2021, which changes, on an emergency and temporary basis, RDC No. 9 of February 20, 2015, which approves the regulation for conducting clinical trials with medicines in Brazil (See ...

Peru Profile Updated in ClinRegs

Nov 23, 2021 - The Peru profile in ClinRegs has been reviewed and updated with the following information: New National Institute of Health (Instituto Nacional de Salud (INS)) regulation and corresponding guidance issued on the application of sanctions during clinical trials (See Trial Authorization and ...

South Africa Profile Updated in ClinRegs

Nov 5, 2021 - The South Africa profile in ClinRegs has been reviewed and updated to include the following: The 3rd edition of the South African Good Clinical Practice: Clinical Trial Guidelines Updated safety reporting timeframes, including for foreign reports of safety issues in multi-country ...

China Profile Updated in ClinRegs

Oct 28, 2021 - The China profile in ClinRegs has been reviewed and updated with the following information: New Personal Information Protection Law to ensure the safety of the personal information processed during clinical trials (See Definition of Sponsor and Quality, Data & Records ...

Thailand Regulatory Fees Information Updated

Oct 19, 2021 - The Thailand profile in ClinRegs has been updated to reflect the applicable fees listed in the July 26, 2017, Thai Food and Drug Administration fees notification, which is currently in force. See Regulatory Fees for more information. Sources Revised During this Update: (Regulation) Notification ...

Guinea Profile Updated with Revised CNERS Application

Oct 14, 2021 - The Guinea profile in ClinRegs has been updated to include version 7 of the National Ethics Committee for Health Research (Comité National d'Ethique pour la Recherche en Santé (CNERS)) Application Form for the Ethical Evaluation of a Research Project, which was issued in July 2021. ...