The Saudi Food and Drug Authority (SFDA) revealed a new draft regulation specifying controls for the release of local and imported human vaccine batches before they are marketed to ensure their safety, granting a maximum of 45 working days to issue approved clearance certificates.

The regulatory document, issued on June 10, 2026, and opened for public consultation, is based on the authority's system issued by Royal Decree No. M/6 dated 25 Muharram 1428 AH.

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The SFDA clarified that these procedures include all vaccines used in the Ministry of Health's National Immunization Program, in addition to non-national programs. The new oversight procedures include independent evaluation of each vaccine batch individually, review of the production protocol, and conducting quality control tests when needed for all products, whether locally manufactured or imported.

Quality Stability Verification

The authority emphasized that these proactive steps aim to verify the stability of batch quality before commercial distribution, as any quality issues could negatively impact immunization programs and threaten public health strategies. Regarding timelines, the authority set 45 working days to issue the official clearance certificate for each batch, starting from the date the National Control Laboratory receives samples and all requirements are fulfilled. The draft regulation noted a fast track for issuing certificates within just seven working days, designated for exceptional circumstances such as public health emergencies. The document explained that ensuring the quality, safety, and efficacy of vaccines is primarily the responsibility of manufacturing companies, while the authority is responsible for establishing procedures to guarantee that for local use or export. The authority mandated companies to provide production protocols, certificates of analysis, and supply samples in suitable condition, in addition to submitting a comprehensive annual report for biological products.

Strict Oversight

The authority warned against any negligence or failure to meet standards, noting that it will directly contact relevant authorities upon detecting any results outside approved specifications to evaluate corrective and preventive actions. It added that companies will be required to conduct an immediate investigation to identify root causes of any defect and determine its impact on vaccine safety and quality, with non-conforming batches rejected. The SFDA has designated an email address to receive inquiries from beneficiaries and companies regarding batch release procedures, to ensure transparency of communication and remove obstacles. This document is currently a draft that may be modified based on feedback and suggestions, and is not considered a final effective guide until officially approved by the authority.