Updates

TZA flag Tanzania Profile Updated with Clarified Records Retention Requirements

Oct 16, 2023 - The Tanzania profile in ClinRegs has been updated to clarify records retention requirements related to the following: National Health Research Ethics Committee (NatHREC) records for prematurely terminated studies (see Ethics Committee) Sponsor and investigator retention ...

VNM flag Vietnam Profile Updated with Personal Data Protection Decree

Sep 28, 2023 - The Vietnam profile in ClinRegs has been updated to include Decree No. 13/2023/ND-CP – Protection of Personal Data, which took effect on July 1, 2023. The Decree regulates the protection of personal data and the personal data protection responsibilities of relevant agencies, organizations, ...

GIN flag Guinea Profile Updated

Sep 22, 2023 - The Guinea profile in ClinRegs has been reviewed and updated as follows: Updated Ministry of Health and Public Hygiene (Ministère de la Santé et de l'Hygiène Publique (MSHP)) contact information and details on the MSHP’s Medicine Division (See Regulatory Authority) New safety reporting ...

MLI flag Mali Profile Updated

Sep 18, 2023 - The Mali profile in ClinRegs has been reviewed and updated as follows: New Directorate of Pharmacy and Medicine (la Direction de la Pharmacie et du Médicament (DPM)) clinical trial application form providing submission documentation requirements (See Scope of Assessment, Regulatory Fees, ...

DRC flag DRC Profile Updated

Sep 8, 2023 - The DRC profile in ClinRegs has been reviewed and updated as follows: New details regarding clinical trial application submissions (See Submission Process and Submission Content) Reorganization of the information included in Scope of Assessment, Submission Process, and Documentation ...

MWI flag Malawi Profile Updated

Aug 25, 2023 - The Malawi profile in ClinRegs has been reviewed and updated as follows: Updated Pharmacy and Medicines Regulatory Authority (PMRA) serious adverse event guidance, clarifying reporting timeline requirements (See Safety Reporting)  New PMRA forms for declaration of intent, declarations ...

LBR flag Liberia Profile Updated

Aug 18, 2023 - The Liberia profile in ClinRegs has been reviewed and updated as follows: Reorganization of the information included in Scope of Assessment, Risk & Quality Management, and Required Elements Addition of Atlantic Center for Research and Evaluation Institutional ...
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