Uganda Profile Updated
The Uganda profile in ClinRegs has been reviewed and updated with the following information, which is current as of March 10, 2025:
- New details on clinical trial application and review processes and reporting requirements from the 2024 updates of the National Drug Authority (NDA)’s regulation and guidelines on the conduct of clinical trials (See Scope of Assessment, Regulatory Fees, Scope of Review and the Clinical Trial Lifecycle topic)
- Additional details on records to be maintained at clinical trial sites (See Data & Records Management)
- Additional details on informed consent form (ICF) requirements (See Required Elements)
- Updated clinical trial application forms and documents (See Scope of Assessment, the Clinical Trial Lifecycle topic, and Site/Investigator Selection)
- The NDA’s customer self-service portal, the integrated Regulatory Information Management System (iRIMS), which can be used for submitting clinical trial applications (See Submission Process)
- Additional information and resource regarding annual data protection and privacy compliance reports (See Personal Data Protection)
Sources Added During this Update:
(Article) PDPO Launches Toolkit to Empower Organizations Comply (UGA-43) (Date Unavailable)
Personal Data Protection Office
(Document) Template: Annual Data Protection and Privacy Compliance Report to Personal Data Protection Office (PDPO) (UGA-41) (July 2023)
Personal Data Protection Office
(Form) Format of the Clinical Trial Application Form (CTA) (UGA-39) (Revision No. 1) (Effective September 19, 2024)
National Drug Authority
(International Guidance) ICH Harmonised Tripartite Guideline: Structure and Content of Clinical Study Reports (E3) (UGA-38) (Step 4 Version) (November 30, 1995)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(Webpage) EA health Official East African Health Portal – Uganda National Health Research Organisation (UGA-42) (Current as of March 10, 2025)
East African Health Research Commission
(Webpage) National Drug Authority – Clinical Trials (UGA-36) (Last Updated February 3, 2025)
National Drug Authority
(Webpage) NDA integrated Regulatory Information Management System (iRIMS) (UGA-40) (Current as of March 10, 2025)
National Drug Authority
(Webpage) Pan African Clinical Trials Registry (UGA-35) (Current as of March 10, 2025)
Pan African Clinical Trials Registry
(Webpage) Uganda National Council for Science and Technology – Research Ethics Committee Accreditation (UGA-37) (Current as of March 10, 2025)
Uganda National Council for Science and Technology
Sources Revised During this Update:
(Regulation) The National Drug Policy and Authority (Conduct of Clinical Trials) Regulations, 2024 (S.I. No. 29 of 2024) (NDPA-CTReg) (May 24, 2024)
Ministry of Health
(Guidance) Guidelines on the Conduct of Clinical Trials in Uganda (Revision No. 1) (G-CTConduct) (Effective October 14, 2024)
National Drug Authority
(Guidance) Guidelines on Good Clinical Practice in the Conduct of Clinical Trials Involving Human Participants (Revision No. 1) (G-TrialsGCP) (Effective October 14, 2024)
National Drug Authority
(Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products - Annexes (Revision No. 4) (G-GMPAnnexes) (Effective July 10, 2024)
National Drug Authority
(Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products Part I - Basic Requirements for Medicinal Products (Revision No. 5) (G-GMPMedicinal) (Effective July 10, 2024)
National Drug Authority
(Guidance) Guidelines on Good Manufacturing Practice for Medicinal Products Part II – Basic Requirements for Active Pharmaceutical Ingredients (Revision No. 2) (G-GMP-APIs) (Effective July 10, 2024)
National Drug Authority
(Document) Format for Clinical Trial Protocol (UGA-12) (2024)
National Drug Authority
(Document) Format for Investigator’s Brochure (UGA-4) (Revision No. 1) (Effective September 19, 2024)
National Drug Authority
(Document) Format of Clinical Trial Report (UGA-6) (Revision No. 1) (Effective September 19, 2024)
National Drug Authority
(Document) Format of Report for Terminated Clinical Trial (UGA-5) (Revision No. 1) (Effective September 19, 2024)
National Drug Authority
(Document) Labelling Investigational Drug Products for Clinical Trial (UGA-7) (2024)
National Drug Authority
(Form) Application for Additional Investigators, Change of Investigator or Additional Clinical Trial Sites (UGA-13) (2024)
National Drug Authority
(Form) Application Form for Amendment of Conditions of a Clinical Trial (UGA-19) (Revision No. 1) (Effective September 19, 2024)
National Drug Authority
(Form) Application Form for Renewal of Authorisation of Clinical Trial (UGA-32) (Revision No. 1) (Effective September 19, 2024)
National Drug Authority
(Form) CTA Amendments Screening Form (UGA-22) (Revision No. 3) (Effective September 19, 2024)
National Drug Authority
(Form) CTA Screening Renewal Form (UGA-2) (Revision No. 1) (Effective September 19, 2024)
National Drug Authority
(Form) Declaration by Principal Investigator (UGA-16) (2024)
National Drug Authority
(Form) Declaration by Sponsor and Principal Investigator of Funds of the Clinical Trial (UGA-15) (2024)
National Drug Authority
(Form) Initial CTA Screening Checklist (UGA-1) (Rev No. 3) (Effective September 19, 2024)
National Drug Authority
(Form) Letter of Authorization from Holder of Patent of Drug, Licensed Person or Manufacturer of Drug (UGA-18) (Revision No. 1) (Effective September 19, 2024)
National Drug Authority
(Form) Pharmaceutical Data on Dosage Form (UGA-14) (2024)
National Drug Authority
(International Guidance) Declaration of Helsinki (UGA-27) (October 22, 2024)
World Medical Association