Snapshot

The Fast-track/priority review pathway has been developed by the Zambia Medicines Regulatory Authority of Zambia.

This pathway can be used where Fast track review model is used for products that are of high public health concern. This is an expedited model in which applications are reviewed within 90 working days. The dossier is submitted in the CTD format..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Fast track review model is used for products that are of high public health concern. This is an expedited model in which applications are reviewed within 90 working days. The dossier is submitted in the CTD format. However, it has been reported that the agency takes 113 calendar days to perform the review.