Snapshot

The Conditional Approval of Medicines pathway has been developed by the Food and Drug Authority of Ethiopia (EFDA) of Ethiopia.

This pathway can be used where Medicines with indications for seriously debilitating or life-threatening conditions (such as cancer and multi-drug resistant tuberculosis), those used in emergency situations and orphan medicines are major candidates for conditional approval. The following criteria should be fulfilled for conditional approval: 1. The benefit – risk balance of medicine is positive. 2. It is likely that the applicant will provide the comprehensive data. 3. Unmet medical needs will be fulfilled. 4. The immediate availability of the medicine on the market outweighs the risks due to the need for additional data. 5. An early access pathway for medicines that show promising therapeutic effects but for which comprehensive data are not available. 6. Investigational Medicinal product under clinical trial phase 3, but are required for critical life-threatening diseases which have no other alternatives..

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Brazil Canada China EU-EMA Europe Iceland Japan Liechtenstein Mexico Norway Saudi Arabia Singapore South Korea Switzerland Taiwan (Chinese Taipei) Turkey United Kingdom United States WHO

The total target (agency) time for assessment is not stated in the guideline.