Uganda Profile Updated
The Uganda profile in ClinRegs has been reviewed and updated with the following information:
- New and updated guidelines on manufacturing, importing, and managing investigational products (See the Investigational Products topic)
- Additional details on requirements for clinical trial amendments (See Scope of Assessment, Submission Process, and Submission Content)
- New requirements related to clinical trials involving children, pregnant women, and lactating women (See Children/Minors and Pregnant Women, Fetuses & Neonates)
Sources Added During this Update:
(Guidance) Guidelines on the Verification of Applications for the Importation and Exportation of Drugs and Pharmaceutical Raw and Packaging Materials (Revision No. 1) (G-VerImprtExprt) (Effective September 6, 2023)
National Drug Authority
(Guidance) Guidelines on the Conduct of Clinical Trials in Children, Pregnant and Lactating Women in Uganda (G-CTChldrnWmn) (Effective July 10, 2023)
National Drug Authority
(Webpage) National Drug Authority: Management Information System (NDAMIS) (UGA-34) (Current as of February 9, 2024)
National Drug Authority
Sources Revised During this Update:
(Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products - Annexes (Revision No. 3) (G-GMPMedicinalAnnexes) (Effective September 6, 2023)
National Drug Authority
(Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products Part I - Basic Requirements for Medicinal Products (Revision No. 4) (G-GMPMedicinal) (Effective September 6, 2023)
National Drug Authority
(Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products Part II – Basic Requirements for Active Pharmaceutical Ingredients (Revision No. 1) (G-GMPMedicinalAPIs) (Effective September 6, 2023)
National Drug Authority