The SFDA mandates that all pharmaceutical products undergo rigorous registration before market entry. Foreign and domestic manufacturers must submit detailed dossiers in the Common Technical Document (CTD) format, including administrative information, quality data, and clinical study reports. A critical requirement is the translation of key documents, including labels and patient information leaflets, into Arabic to ensure accessibility for Saudi healthcare professionals and patients. Foreign manufacturers must also appoint local authorized representatives to facilitate regulatory communication and compliance oversight.

The SFDA enforces meticulous labeling requirements that ensure clear communication of essential product information. Primary packaging must display product name, strength, manufacturing and expiry dates, and batch numbers in both English and Arabic over every blister pocket. Secondary packaging requires comprehensive information including product name on at least three non-opposing faces, active ingredients, indications, administration methods, warnings, and storage conditions. This bilingual approach ensures that critical pharmaceutical information is accessible to all healthcare stakeholders in the Kingdom.

Saudi Arabia leads the region in pharmaceutical traceability implementation. The SFDA requires all sellable pharmaceutical units to bear GS1 DataMatrix barcodes containing essential tracking information including Global Trade Item Numbers (GTIN), expiration dates, and batch numbers. This sophisticated system enables granular tracking throughout the entire supply chain, from manufacturer to patient, significantly enhancing product integrity and providing robust protection against counterfeiting and diversion.

The SFDA maintains unwavering standards for Good Manufacturing Practices (GMP) compliance across all pharmaceutical manufacturing facilities. Regular inspections and audits ensure adherence to international quality standards, with the authority to conduct site inspections for foreign manufacturers. The regulatory framework includes ongoing post-market surveillance programs to monitor product safety and quality after market approval, with registration certificates valid for five years requiring timely renewal applications.