Updates | ClinRegs

US Profile Updated in ClinRegs

Jan 18, 2022 - The United States profile in ClinRegs has been reviewed and updated with the most current requirements. Key updates include: Data protection requirements (See Quality, Data & Records Management) Updated guidance on eCTD submissions (See Submission ...

Peru Submission Contact Information Updated

Jan 14, 2022 - The Peru profile in ClinRegs has been updated with the following information: Updated contact information for submitting documents and requests to the National Institute of Health (Instituto Nacional de Salud (INS))’s Document Processing System (See Submission ...

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 ...