Snapshot
The Abridged review (Type 2) pathway has been developed by the Zambia Medicines Regulatory Authority of Zambia.
This pathway can be used where This model is used for products that were submitted before 2015. The abridged template was used in the review process. In 2015, the Authority adopted the Quality Overall Summary as the evaluation template following the adoption of the Common Technical Document (CTD) format. This method of review is mainly used for generic products..
This pathway accelerates the regulatory review process.
It is an abridged review (a reliance pathway).
351 calendar days.