The SFDA Conditional Approval Advantage

The Saudi Food and Drug Authority (SFDA) offers a type of approval called “conditional approval.” It is available for new medicines as an accelerated registration to expedite access to essential treatments, especially for serious or life-threatening conditions. Conditional approval is a rolling submission format that allows drug registration based on less comprehensive data than typically required, ensuring timely access while balancing safety and efficacy through post-approval obligations.

Eligibility Criteria

Medicines eligible for conditional approval must fall into one of these categories:

1. Treatment for serious or life-threatening diseases: Applicants must provide substantial justification, using medical or epidemiological data, to confirm the disease’s severity.
2. Emergency use: This includes medications needed for pandemics or significant public health threats as recognized by the World Health Organization or the Saudi Ministry of Health.

Core Requirements for Conditional Approval

Conditional approval (rolling submission) can be granted if SFDA assesses that:

• The risk-benefit balance is positive: Although the clinical data may be less extensive, the product’s benefits must outweigh the potential risks, supported by solid non-clinical and pharmaceutical data.
• Comprehensive clinical data is achievable: The applicant should be able to complete clinical studies to provide thorough data within an agreed timeframe.
• Addresses an unmet medical need: The product should serve patients without adequate treatment or provide a substantial advantage over existing options.
• Immediate availability benefits public health: Applicants must demonstrate that the benefits of immediate availability outweigh the risks of incomplete data.

Obligations and Application Process

The application process includes several steps:

1. Pre-submission advice: Applicants can seek SFDA guidance to confirm eligibility and discuss procedural aspects.
2. Formal application submission: Submit applications through the Saudi Drug Registration (SDR) System. An incomplete eCTD may be accepted under certain conditions. The review timeframe and fees remain the same as regular procedure.
3. SFDA assessment and decision: The authority evaluates the provided data and decides on conditional approval (rolling submission).

Post-Approval Obligations

To uphold safety and efficacy, SFDA requires:

• Monthly summary reports on safety and efficacy.
• Completion of any ongoing or new studies to confirm the positive benefit-risk balance.
• Adjusted reporting schedules for safety data to align with the conditional approval timeframe.

Transitioning and Lapsing

Conditional approval (rolling submission) is initially valid for two years, with options for two-year extensions up to a maximum of six years. After approval, the product may transition to complete registration, be withdrawn, or have its approval extended, depending on the outcome of the final data evaluation.

How to Proceed?

You can leverage our experience securing conditional approval across many applications and scenarios, from missing CMC studies and clinical data shortages to more complex situations. Schedule a call to discuss further or write to us.