Updates | ClinRegs

Guinea Profile Updated with Revised DNPM Contact Information

Mar 14, 2023 - The Guinea profile in ClinRegs has been updated to include a link to the National Directorate of Pharmacy and Medicine (DNPM) website and revised contact information. Sources Added During this Update: (Webpage) National Directorate of Pharmacy and Medicine (DNPM) (GIN-2 - ...

Kenya Profile Updated

Mar 3, 2023 - The Kenya profile in ClinRegs has been reviewed and updated with the following information: New regulations and updated guidelines issued in 2022 on the conduct of clinical trials in Kenya (See Regulatory Authority, Clinical Trial Lifecycle, Sponsorship, Informed Consent, and Investigational ...

Peru Profile Updated with Amended Clinical Trial Authorization Procedures

Feb 22, 2023 - The Peru profile in ClinRegs has been updated to include the Headquarters Resolution No. 252-2022-J-OPE/INS, which modifies the clinical trial authorization procedures (section 7.5) in the Manual of Clinical Trials Procedures (MAN-INS-001). Clinical trial applications and accompanying documentation ...

Australia Profile Updated

Feb 10, 2023 - The Australia profile in ClinRegs has been reviewed and updated with the following information: Data protection requirements related to the collection and handling of personal information, including health information, under the Privacy Act 1988 and the Australian Privacy Principles (See ...

India Profile Updated

Feb 2, 2023 - The India profile in ClinRegs has been reviewed and updated with the following information: New amendment to the New Drugs and Clinical Trials Rules which provides the timelines for when ethics committee registration, clinical trials, investigational product manufacturing, and active ...

Guinea Profile Updated

Jan 27, 2023 - The Guinea profile in ClinRegs has been reviewed and updated with the following information: The National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM)) has been renamed to the National Directorate of Medicines and Pharmacies ...

US Profile Updated

Jan 19, 2023 - The United States profile in ClinRegs has been reviewed and updated with the following information: More detailed descriptions of Food & Drug Administration (FDA) and institutional review board (IRB) clinical trial review processes (See Scope of Assessment and Scope of Review) Supplementary ...