• Pamela Nelson, RN

Updates for Conducting Research in Uganda

I stumbled across this bit of interesting news about changes to conducting research in Uganda.

Africa is so interesting to me and I enjoy working and visiting there often. I welcome the opportunity to work there again to share insights on conducting clinical trials and providing services to companies there as well as in the US that want o develop products there.

Uganda Profile Update

The Uganda profile in ClinRegs has been reviewed and updated where appropriate to reflect current regulatory requirements. Key updates include:

  • Clarification that ethics committee and Uganda National Council for Science and Technology approvals must be received prior to submitting a clinical trial application to the National Drug Authority (NDA) (See the Scope of Assessment section)

  • Notification from the NDA that incomplete clinical trial applications will not be received at the NDA registry and will be returned to the applicant with a checklist of missing items (See the Submission Content and Timeline of Review sections)

  • Updated links to forms related to the clinical trial application process (See the Submission Content and Progress Reporting sections)

  • Information related to clinical trial termination by the sponsor (See the Quality, Data & Records Management section)

  • Information related to adding/changing investigators or trial sites (See the Site/Investigator Selection section)

  • Requirement that a local company in Uganda must submit a letter of authorization from the licensed person or manufacturer of the drug to be the agent of the clinical trial and responsible for all matters pertaining to the NDA clinical trial certificate (See the Manufacturing & Import section)

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National Institute of Allergy and Infectious Diseases | National Institutes of Health

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