Updates | ClinRegs

Mali Profile Updated

Sep 15, 2022 - The Mali profile in ClinRegs has been reviewed for accuracy and updated with the following information: Regulations related to the establishment and member appointment of the Institutional Ethics Committee for Health and Life Sciences Research (CIESS)/University of Sciences, Techniques ...

Malawi Profile Updated

Sep 8, 2022 - The Malawi profile in ClinRegs has been reviewed for accuracy and updated with the following information: A new checklist of Pharmacy and Medicines Regulatory Authority (PMRA) requirements for submitting a clinical trial application (See Submission Process and Submission Content) PMRA ...

Tanzania Profile Updated

Aug 30, 2022 - The Tanzania profile in ClinRegs has been reviewed and updated with the following information: Updated COSTECH National Research Registration and Clearance guidance (See Regulatory Authority and Clinical Trial Lifecycle) New COSTECH Frequently Asked Questions on applying for a research ...

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, ...