Snapshot

The Expedited or “Fast-track” Registration Procedure pathway has been developed by the Medicines Control Authority of Zimbabwe of Zimbabwe.

This pathway can be used where All New Chemical Entities (NCEs) and biological applications, generic applications, major variations and line extensions that have prior approval from a reference regulatory authority will be considered for an abridged review. In addition, all applications for biosimilar medicines will be considered for an abridged review. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from ASEAN Algeria Argentina Armenia Australia Azerbaijan Brazil Canada China Colombia Cuba EU-EMA East African Community (EAC) Egypt GHC-GCC India Indonesia Iran, Islamic Republic of Israel Japan Jordan Kazakhstan Lebanon Malaysia Mexico Moldova, Republic of Russia Saudi Arabia Singapore South Africa South Korea Switzerland Taiwan (Chinese Taipei) Turkey Ukraine United Kingdom United States WHO

Target time = 180 days (including applicant's time). MCAZ however commit in their reliance policy to expedite approval to 3 months when a replica dossier from the applicant and the full evaluation report from the reference NRA are provided.