Snapshot

The Fast track/priority registration pathway has been developed by the National Medicines and Food Administration (NMFA) of Eritrea.

This pathway can be used where Evaluation and registration will be expedited for priority medicines. The following categories of medicines are eligible for fast-track registration approval: 1. Products intended for serious life-threatening diseases and public health emergencies; 2. Public health medicines: these include vaccines and medicines for HIV/AIDS, malaria, tuberculosis, reproductive health and neglected tropical diseases; 3. WHO Prequalified Products (WHO-PQP) and products registered in Stringent Regulatory Authorities (SRA); 4. Products procured by the Ministry of Health through tender. .

It is an abridged review (a reliance pathway).

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

Complete applications eligible for fast track/abridged registration will be processed within 3 months of receiving the applications.