Updates | ClinRegs

UK Profile Updated with Revised MHRA Fees

Apr 7, 2023 - The United Kingdom profile in ClinRegs has been updated to include the revised fee schedule for clinical trials, which was issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) on April 1, 2023 (See Regulatory Fees). Sources Revised During this ...

China Profile Updated to Include New NMPA Guidelines

Apr 6, 2023 - The China profile in ClinRegs has been updated to include the following guidelines issued by the National Medical Products Administration (NMPA) in March 2023: New guidance regarding the Phase III pre-clinical trial meeting with the Center for Drug Evaluation when ...

Uganda Profile Updated

Mar 22, 2023 - The Uganda profile in ClinRegs has been reviewed and updated with the following information: Uganda National Council for Science and Technology (UNCST) guidelines from 2022 regarding community engagement in research (See Initiation, Agreements & Registration) UNCST correspondence ...

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 ...