Updates | ClinRegs

South Africa Profile Updated

Jan 17, 2025 - The South Africa profile in ClinRegs has been reviewed and updated with the following information:Updated ethics in health research guidelines from the National Department of Health (See the Ethics Committee, Clinical Trial Lifecycle, Sponsorship, Informed Consent, and Specimens topics)2024 ...

Sierra Leone Profile Updated

Jan 7, 2025 - The Sierra Leone profile in ClinRegs has been reviewed and updated with the following information:Pharmacy Board of Sierra Leone (PBSL) clinical trial application form and checklist (See Submission Content)Reorganization of information related to follow-up serious adverse event reporting requirements ...

Canada Profile Updated with Single Ethics Committee Review Guidance

Dec 23, 2024 - The Canada profile in ClinRegs has been updated to include the Panel on Research Ethics (PRE) guidance on single ethics committee review for minimal risk research across multiple jurisdictions. The guidance supports the implementation of the Tri-Council Policy Statement: Ethical Conduct for ...

China Profile Updated

Dec 20, 2024 - The China profile in ClinRegs has been reviewed and updated with the following information:Details from 2024 on the transfer of China’s human genetic resources (HGR) management from the Ministry of Science and Technology (MOST) to the State Council’s National Health Commission (NHC) (See ...

Mali Profile Updated

Dec 5, 2024 - The Mali profile in ClinRegs has been reviewed and updated as follows:Additional details on training requirements for members of the Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques and Technologies of Bamako (USTTB) (See Scope ...

DRC Profile Updated

Nov 27, 2024 - The DRC profile in ClinRegs has been reviewed and updated with the following information:Personal data protection requirements from a 2023 law (See Personal Data Protection)Supplementary Congolese Pharmaceutical Regulatory Authority (Autorité Congolaise de Réglementation Pharmaceutique (ACOREP)) ...

India Profile Updated with DCGI Order Regarding Local Clinical Trial Waivers

Nov 26, 2024 - The India profile in ClinRegs has been updated to include an order issued by the Drugs Controller General of India (DCGI) specifying countries for which the DCGI may waive the requirement to conduct a local clinical trial if the new drug is already approved in one of the named countries and ...