SFDA Guidance: Conditional Approval for Medicinal Products for Human Use

The Saudi Food and Drug Authority recently released (13- November-2022) updated guidance on "Conditional Approval for Medicinal Products for Human Use", that supports the development of new medicines to treat serious or life-threatening conditions where there is an unmet medical need.

For medical needs that go unmet and for the good of public health, it may be necessary to grant marketing authorizations with less complete data than is usual and subject to certain conditions, called a "Conditional Approval."

Conditional approval is issued for products determined by SFDA when technical requirements that must be provided in the dossier are not met or completed and the benefits of the product outweigh its potential risks.

In this document, rules are outlined for granting Conditional Approvals for new human medicines, including biologics, subject to specific obligations according to the SFDA.

The applicant may present a request for conditional approval with an application, accompanied by documentation demonstrating that the product meets the criteria and is eligible.

The conditional approval is effective for two years and may be renewed, but this approval is not intended to remain conditional indefinitely.

Click this LINK to know more about the Requirements for applying Conditional Approval for Medicinal Products for Human Use