Snapshot

The Registration of Low-Risk Medicines pathway has been developed by the Ethiopian Food and Drug Authority (EFDA) of Ethiopia.

This pathway can be used where The general category of products listed below are eligible for market authorization application: a. Keratolytic; b. Anti-dandruff; c. Topical antibacterial; d. pholcodine linctus or a codeine-containing combination analgesic; e. Medicated plasters/ patch/ pad; f. Non-steroidal and antihistaminic having wide therapeutic index; g. Multivitamin and minerals; h. Anthelmintic having local action; i. Dermatological products having local action; j. Locally-acting lozenges/ pastilles; k. Topical analgesic/ counter-irritants; l. Anti-acne; m. Oral mucosal analgesic. The lists of specific products indicated in annex I of the guideline in the References section of this webpage are recognized as low risk products. However, the list will be regularly updated for products that fit into the above general category of medicines based on the EFDA's inclusion criteria..

It is an abridged review (a reliance pathway).

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

As the low risk medicine applications needs abbreviated review process, shorter target times apply to these types of applications. The Authority may make requests for further information from the applicant if there are issues arising at any stage of the evaluation process and granting the marketing authorization will be based on the outcome of the abbreviated review outcome.