Snapshot

The Fast track procedure pathway has been developed by the Egyptian Drug Authority of Egypt.

This pathway can be used where imported and locally produced products.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia Austria Belgium Canada Denmark Finland France Germany Iceland Ireland Italy Japan Luxembourg Netherlands New Zealand Norway Portugal Spain Sweden Switzerland United Kingdom United States

Target time assessment is TIMELINES FOR BIOLOGICAL PRODUCTS: 1. Applicant submits inquiry through automated system to receive inquiry approval. (30 working days). 2. Applicant submits pricing file. From date of pricing certificate issuance: 60 WD for imported products; 2 years for local products. 3. Applicant request via e-mail for CTD file submission. (3 WD) 4. Biological Reception Specialist (BRS) arranges an appointment with relevant EDA units. (20 WD). EDA units = Biological Inspection Unit, Stability Unit, Scientific Evaluation Unit, Biovigilance Unit, Reception Unit, Labs. 5. Each EDA unit inform reception BRS with the validation status. If validation is successful, then clock review starts (evaluation phase). 6. Evaluation phase: 120 WD for normal track; 90 WD for fast track. TIMELINES FOR MEDICINE: 1. Imported products approved from FDA & EMA in addition to one of the SRAs or WHO prequalified (Fast track): Application = 12; Pricing+Naming+PV = 30; Screening & Evaluation = 25. 2. Imported products approved from FDA or EMA in addition to one of the SRAs or WHO prequalified (Fast track): Application = 12; Pricing+Naming+PV = 30; Screening & Evaluation = 50. 3. Imported Products marketed in one of SRAs or WHO-Prequalified with assessment timelines (Fast Track): Application = 18; Pricing+Naming+PV = 30; Screening & Evaluation = 74. .