Uganda Profile Updated
The Uganda profile in ClinRegs has been reviewed and updated with the following information:
- Updated documents from the Uganda National Council for Science and Technology (UNCST) regarding the research clearance process and accredited ethic committees (See Regulatory Authority, Authorizing Body, and the Clinical Trial Lifecycle topic)
- Data protection requirements related to processing of personal data and data controller responsibilities (See Quality, Data & Records Management and the Informed Consent topic)
- Minor amendments to Ministry of Health regulations on clinical trial conduct and pharmacovigilance (See Scope of Assessment, the Clinical Trial Lifecycle topic, and the Sponsorship topic)
- Additional supplemental resource covering dissemination of biological specimens by biobanks (See Specimen Import & Export)
Please note that the UNCST has informed ClinRegs that some of the UNCST guidelines are being updated. When they have been finalized, ClinRegs will notify you and will update the Uganda profile where appropriate.
Sources Added During this Update:
(Legislation) The Data Protection and Privacy Act, 2019 (NITA-U-PrivAct) (May 3, 2019)
Parliament
(Regulation) The Data Protection and Privacy Regulations, 2021 (NITA-U-PrivReg) (March 12, 2021)
National Information Technology Authority - Uganda
(Regulation) The National Drug Policy and Authority (Conduct of Clinical Trials) (Amendment) Regulations, 2021 (NDPA-CTRegAmdt) (July 2, 2021)
Ministry of Health
(Regulation) The National Drug Policy and Authority (Pharmacovigilance) (Amendment) Regulations, 2021 (NDPA-PVRegAmdt) (July 2, 2021)
Ministry of Health
(Guidance) National Research Biobanking Guidelines (G-Biobank) (January 2021)
Uganda National Council for Science and Technology
(Document) The National Research Clearance Process (UGA-20) (Date Unavailable)
Uganda National Council for Science and Technology
(Document) Accredited RECs (UGA-11) (2022)
Uganda National Council for Science and Technology
(Webpage) National Drug Authority – Innovation & Research Desk (UGA-10) (Current as of March 3, 2022)
Ministry of Health
(Webpage) Uganda National Council for Science and Technology – Who We Are (UGA-30) (Current as of March 3, 2022)
Uganda National Council for Science and Technology
Sources Revised During this Update:
(Regulation) The National Drug Policy and Authority (Fees) Regulations, 2022 (S.I. 2022/5) (NDPA-FeesReg) (Effective March 1, 2022)
Ministry of Health
(Not Available Online) NIAID Communication with Makerere University (February 2022) (UGA-31)
(Webpage) Directorate of Product Safety (UGA-29) (Current as of March 3, 2022)
National Drug Authority
(Webpage) Uganda National Council for Science and Technology – Contact Us (UGA-25) (Current as of March 3, 2022)
Uganda National Council for Science and Technology