Product Registration Precedent
1 clinical trials approved from July 2012 to July 2014.
Post Registration Pharmacovigilance Requirements
USAID's assessment "Pharmacovigilance in Rwanda: A Systems Analysis" in 2009 stated that there is no approved policy on pharmacovigilance, but that the National Drug Authority Bill contains a pharmacovigilance component.
An Adverse Event Reporting Agreement must be made with the National Ethics Committee. Adverse event reporting needs to comply with ICH Guidelines for Clinical Safety Data Management. Local serious AEs need to be reported by the PI within 24 hours to the sponsor, who then has 24 hours to report to the ethics committee.
September 30,, 2014.