Snapshot

The Abridged Review pathway has been developed by the Tanzania Medicines & Medical Devices Authority of Tanzania.

This pathway can be used where This pathway is for WHO-prequalified and stringent regulatory authority (SRA)-approved products. The pathway applies to new chemical entities and generic medicines applications for marketing authorisation of medicinal products that have been approved or registered by TMDA, AMA, EMA, WHO, NRAs with WHO-Maturity level 3/ML4, WLAs, EAC-MRH, IGAD, SADC-MRH and other recognized regional harmonisation initiatives. .

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 Brazil Canada China EU-EMA Japan Mexico Rwanda Saudi Arabia Singapore South Korea Switzerland Taiwan (Chinese Taipei) Turkey United Kingdom United States

Target time assessment is 90 calendar days.