(2008; 44 pages)
These guidelines as outlined are drawn in conformity with the legal requirements of the National Drug Policy and Authority Act. It is required that all medicines used in Uganda are registered with the National Drug Authority (NDA), and any clinical trial using registered or unregistered medicine must receive written approval from NDA for that purpose.
The guidelines set out the procedures that should be followed by applicants who wish to conduct clinical trials in Uganda and the steps that NDA will take to review, evaluate and permit the conduct of such trials.
The review and approval process in Uganda is expected to take on average 30 working days from the time the completed application is received by the Drug Information Department in NDA. Approval by NDA for conduct of the clinical trial does not absolve the applicant from compliance with all laws and regulations in Uganda. In particular, other laws may apply to import or use of infectious or genetically modified organisms.