Snapshot

The Verification Review (Type 1) pathway has been developed by the Zambia Medicines Regulatory Authority of Zambia.

This pathway can be used where This type of review model is used by ZAMRA for products that have been prequalified by the WHO or approved by stringent regulatory authorities (SRAs). The applicant must demonstrate sameness of the dossier submitted with that reviewed and prequalified by WHO. The Authority does not review the submission but rather verifies sameness of the dossier with that submitted and prequalified by WHO..

This pathway accelerates the regulatory review process.

It is a verification review (a recognition pathway).

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

The target time for assessment is 90 calendar days for verification review (Type 1).