Snapshot

The Prioritization Request pathway has been developed by the DPM Tunisie of Tunisia.

This pathway can be used where medicines for human use.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is Acceptability (screening) = 20 days Applicant response = 30 days Technical assessment = 120 days Applicant response = 120 days for the 1st cycle and 60 days for the 2nd and 3rd cycles 2nd or 3rd Technical Assessment (chemical products) = 60 days 2nd or 3rd Technical Assessment (biological products) = 120 days CTSP stage = 60 days Applicant response = 60 days MA decision = 30 days.