Snapshot
The Fast-track assessment of CTD dossier applications pathway has been developed by the of Uganda.
This pathway can be used where pharmaceutical products for human use.
This pathway accelerates the regulatory review process.
It is an abridged review (a reliance pathway).
The timeline for feedback on a CTD fast-track application is 3 months. This period does not include additional information if requested. The timeline for feedback on additional information is 1 month.