Snapshot

The Reliance Procedure (Medicines approved by National Regulatory Authorities under MoU with MCAZ) pathway has been developed by the of Zimbabwe.

This pathway can be used where products with marketing authorization issued by National Regulatory Authorities (NRAs) with which Zimbabwe has signed Memoranda of Understanding (MoUs) on regulatory cooperation..

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is All applications submitted under the expedited review pathway shall be processed within a defined regulatory timeframe of ninety (90) calendar days, referred to as MCAZ time. This timeframe represents the period during which the MCAZ actively evaluates the application. It is important to note that MCAZ time excludes any duration taken by the applicant to respond to queries, provide additional documentation, or address deficiencies identified during the review process. Applicants are therefore encouraged to ensure timely and complete responses to facilitate adherence to the expedited review timeline and enable prompt regulatory decision-making. .