Updates | ClinRegs

Guinea Profile Updated

Aug 24, 2022 - The Guinea profile in ClinRegs has been reviewed and updated with the following information: Legislation defining the National Directorate of Pharmacy and Medicine (Direction Nationale de la Pharmacie et du Médicament (DNPM))’s drug registration, authorization, and importation oversight ...

Australia Profile Updated with Revised Fees Document and GCP Inspection Guidance

Aug 23, 2022 - The Australia profile in ClinRegs has been updated with the following information: Updated Therapeutic Goods Administration (TGA) document regarding fees for the evaluation of unapproved medicines and biologicals (See Regulatory Fees) New guidance on the TGA’s Good Clinical Practice ...

Liberia Profile Updated

Aug 18, 2022 - The Liberia profile in ClinRegs has been reviewed for accuracy and updated with the Liberia Medicines and Health Products Regulatory Authority (LMHRA) fees schedule for clinical trial application submissions (See Regulatory Fees). Sources Added During this Update: (Document) ...

Brazil Profile Updated with New Expiration Date for Public Health Emergency Requirements and Clarifications to Safety Reporting Requirements

Aug 16, 2022 - The Brazil profile in ClinRegs was updated with the following information: Inclusion of Ordinance No. 913, which declared an end to Brazil’s public health emergency related to COVID-19 as of May 22, 2022 (See Scope of Assessment and Timeline of Review) Inclusion of Resolution No. 683, ...

Canada Profile Updated

Aug 11, 2022 - The Canada profile in ClinRegs has been reviewed and updated with the following information: New name of the Pharmaceutical Drugs Directorate (formerly Therapeutic Products Directorate) in Health Canada and updated contact information (See Regulatory Authority) Updates to the process ...

DRC Profile Updated

Jul 19, 2022 - The DRC 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 this Update: (Not ...

Bangladesh Now Available in ClinRegs

Jul 14, 2022 - Bangladesh's clinical research regulatory information is now available in ClinRegs. This addition brings the total number of countries in ClinRegs to 23. Countries currently included are based on NIAID's international clinical research priorities, and open access is provided to the general ...