Snapshot

The Authorization for Emergency Use for Medicinal Products, Medical Devices and IVDs pathway has been developed by the Rwanda Food and Drugs Authority (RFDA) of Rwanda.

This pathway can be used where Authorization for Emergency Use (AEU) allows for the expedited approval of medicinal products, medical devices and IVDs in the following conditions: • The disease for which the product is intended is serious or immediately life threatening, has the potential of causing an outbreak, epidemic or pandemic and it is reasonable to consider the product for an AEU assessment, e.g., there are no licensed products for the indication or for a critical subpopulation (e.g., children); • Existing products have not been successful in eradicating the disease or preventing outbreaks (in the case of vaccines and medicines); in emergency situations for the diagnosis, treatment, or prevention of serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives. Generally, the Authority will issue an AEU in the following conditions: 1. The disease causative agent/item specified in the declaration of Public Health Emergency can cause a serious or life-threatening disease or condition; 2. Based on the totality of scientific evidence available, including data from adequate and well-controlled Clinical Trials, if available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition caused by the agent specified in the declaration of emergency; 3. The known and potential benefits outweigh the known and potential risks of the product when used to diagnose, prevent, or treat the serious or life-threatening disease or condition that is the subject of the declaration; and 4. No adequate, approved, and available alternatives to the product for diagnosing, preventing, or treating such serious or life-threatening disease or condition..

It is an abridged review (a reliance pathway).

The timelines for processing of an AEU will depend on the following: a) Product profile; b) The existence, if any, of pending applications for the AEU; c) The nature of the emergency and d) Other relevant factors. Although the length of time required for action will vary, the Rwanda FDA recognizes that it is likely that, in an emergency situation that is occurring or believed imminent, a request for consideration for an AEU will be processed within 15 working days.