NAFDAC ELECTRONIC CLINICAL TRIAL APPLICATION PLATFORM (NAFDAC-eCTAP) IS NOW LIVE!
As NAFDAC continues in her quest to provide seamless and transparent systems for applicants interfacing with the different regulatory processes, the Agency in partnership with NUVOTEQ and support from the Gates Foundation has established the NAFDAC Electronic Clinical Trial Application Platform, NAFDAC-eCTAP, for the submission of all clinical trial applications.
NAFDAC-eCTAP is an online platform provided to foster shorter turnaround times, mitigate challenges of transmitting and review of paper-based submissions, improve applicant’s ability to track the progress of clinical trial applications, and interface better with systems rather than individuals.
NAFDAC-eCTAP is the first electronic application platform of its kind in Africa for the submission of the following:
New Clinical Trial Applications
Clinical Trial Amendments
Applications for permit to import Investigational Medicinal Products (IMP) for clinical trials
Clinical trial progress/final reports
The NAFDAC-eCTAP can be accessed on the NAFDAC website as well as using the link below: https://nafdac.smapply.io/acc/r/?g=82858
The Agency is also working to provide electronic platforms for other activities related to clinical trials such as safety reporting during clinical trials and Good Clinical Practice (GCP) Inspection process, as we remain Customer-focused and Agency-minded.