Updates | ClinRegs

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, ...

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 ...

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 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 ...

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 ...

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 ...

Zimbabwe Profile Updated

Aug 11, 2023 - The Zimbabwe profile in ClinRegs has been reviewed and updated with the following information: Medicines Control Authority of Zimbabwe (MCAZ) regulatory fees for foreign researchers; updated pharmacy licensing and unregistered medicine import/export fees; and Research Council of Zimbabwe ...