The Saudi Food and Drug Authority (SFDA) has implemented a process for conditional approval of new medicines to expedite access to essential treatments, especially for serious or life-threatening conditions. Conditional approval 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:
- Treatment for serious or life-threatening diseases: Applicants must provide substantial justification using medical or epidemiologic data to confirm the disease severity.
- Emergency usage: This includes medications needed for pandemics or significant public health threats as recognized by the World Health Organization or Saudi Ministry of Health.
Core Requirements for Conditional Approval
Conditional approval can be granted if SFDA assesses that:
- Risk-benefit balance is positive: While the clinical data might 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 capable of completing 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 advantages of immediate availability outweigh the risks associated with incomplete data.
Obligations and Application Process
The application process includes several steps:
- Pre-submission advice: Applicants can seek SFDA guidance to confirm eligibility and discuss procedural aspects.
- Formal application submission: Applications are submitted through the Saudi Drug Registration (SDR) System. Incomplete eCTD is accepted, but the review timeframe and fees are the same as the regular procedure.
- SFDA assessment and decision: The authority evaluates and decides on the conditional approval based on the provided data.
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 is initially valid for two years, with options for two-year extensions up to a maximum of six years. Post-approval, the product may transition to a full registration, be withdrawn, or have its approval extended, depending on the final data evaluation.
This conditional approval procedure reflects SFDA’s commitment to advancing public health by making vital medicines available quickly without compromising on rigorous scientific assessment and ongoing monitoring.
