Updates | ClinRegs

Peru Profile Updated with Revised Sponsor Registration Form

Mar 9, 2022 - The Peru profile in ClinRegs has been updated to include the revised National Institute of Health (Instituto Nacional de Salud (INS)) sponsor registration form and related information. (See Scope of Assessment) Sources Added During this Update: (Regulation) Directorial Resolution No. ...

Uganda Profile Updated

Mar 3, 2022 - The Uganda profile in ClinRegs has been reviewed and updated with the following information: Updated documents from the Uganda National Council for Science and Technology (UNCST) regarding the research clearance process and accredited ethic committees (See Regulatory Authority, Authorizing ...

UK Profile Updated

Feb 24, 2022 - The United Kingdom profile in ClinRegs has been reviewed and updated with the following information: Updates to responsibilities and contact information of the Medicines and Healthcare products Regulatory Agency (MHRA) (See Regulatory Authority) Updated review and submission guidelines ...

Mexico Profile Updated

Feb 16, 2022 - The Mexico profile in ClinRegs has been reviewed and updated with the most current requirements. Key updates include: New pharmacovigilance reporting guidelines providing procedures required to prepare reports and extend sanitary registrations for drug products (See Safety Reporting ...

Kenya Profile Updated

Jan 27, 2022 - The Kenya profile in ClinRegs has been reviewed and updated with the following information: Updates to the National Guidelines for Ethical Conduct of Biomedical Research Involving Human Participants in Kenya (See Submission Content, and the Ethics ...

Sierra Leone: Updated PBSL Information and Links

Jan 19, 2022 - The Sierra Leone profile in ClinRegs was updated as follows: Updated Pharmacy Board of Sierra Leone (PBSL) contact information (see Regulatory Authority) Updated description of the PBSL’s Pharmacovigilance & Clinical Trials ...

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 ...