Snapshot

The Emergency Use Authorization of Medical Products pathway has been developed by the of Zimbabwe.

This pathway can be used where Unregistered medical product (allopathic medicines, complementary medicines, biological medicinal products and medical devices) for a declared public health emergency. These products and their uses are not approved, cleared or registered under Section 30 of the Medicines and Allied Substances Control Act (Chapter 15:03). .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is To allow the MCAZ evaluation process to begin before a determination of actual or potential emergency, MCAZ recommends that a pre-emergency submission be filed using existing processes to the extent feasible and appropriate. The extent of, and timelines for, evaluation of such submission will be determined on a case-by-case basis and will depend on the nature of the emergency. Subject to exigent circumstances beyond MCAZ's control, the Authority anticipates that pre-emergency submissions for high priority activities may be evaluated in a matter of weeks to months. The timelines for evaluation and action on a request for consideration for an EUA will depend on the product profile, the existence (if any) of pending applications for the product, the nature of the emergency, and other relevant factors. In cases where complete clinical trials data is not yet available as is usually the case in a public health emergency, MCAZ will review data as they become available from ongoing studies. Although the length of time required for action will vary, MCAZ recognizes that it is likely that, in an emergency situation that is occurring or believed imminent, a request for consideration for an EUA will be acted upon within 2 weeks. .