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As the Saudi pharmaceutical market expands and aligns itself with international standards, the Law of Pharmaceutical Establishments and Products (2023) has emerged as the primary legislation governing medicinal products, herbal preparations, and pharmaceutical operations in the Kingdom.

This law, issued under Royal Decree No. M/108, dated 19/11/1444 AH (corresponding to June 2023), is enforced by the Saudi Food and Drug Authority (SFDA) and provides a comprehensive legal foundation for drug regulation in the country.

Scope of the Law

The Law of Pharmaceutical Establishments and Products (2023) establishes SFDA’s full Regulatory authority across the lifecycle of medicinal products—covering:

  • Manufacturing, importing, and exporting
  • Product registration and marketing authorization
  • Distribution and retail operations
  • Advertising and promotional oversight
  • Licensing of pharmaceutical establishments
  • Pharmacovigilance obligations
  • Inspection and enforcement procedures

This law applies not only to chemical drugs but also to biologicals, biosimilars, herbal products, homeopathic medicines, radiopharmaceuticals, and blood-derived products.

Key Regulatory Requirements for Compliance

1. Mandatory Product Registration

All medicinal products must be registered with the SFDA through its Drug Registration System (DUR). The CTD (Common Technical Document) format is required, ensuring harmonization with ICH standards. Products cannot be marketed without valid SFDA approval.

2. Licensing of Entities

Manufacturers, importers, distributors, wholesalers, and pharmacies must obtain SFDA-issued licenses. Facilities are subject to periodic GMP audits and Regulatory inspections.

3. Local Representation

Foreign manufacturers must appoint a local authorized representative or agent responsible for Regulatory submissions, safety monitoring, and liaising with the SFDA.

4. GMP Compliance

Manufacturers—both domestic and international—must comply with SFDA’s GMP Guidelines, based on WHO and PIC/S standards. SFDA may conduct its own inspections or recognize certifications from trusted Regulatory authorities.

5. Pharmacovigilance Obligations

Marketing Authorization Holders (MAHs) must:

  • Appoint a Qualified Person for Pharmacovigilance (QPPV) based in Saudi Arabia
  • Maintain a functional pharmacovigilance system
  • Submit Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs)
  • Report adverse drug reactions using the Tiqyam e-system

6. Labeling and Promotion

SFDA mandates that product labels and patient information leaflets (PILs) be provided in both Arabic and English. All promotional activities require pre-approval, and restrictions apply to advertising prescription medications directly to consumers.

Alignment with International Best Practices

The 2023 law reinforces Saudi Arabia’s commitment to international Regulatory convergence. It mirrors the frameworks of leading health authorities such as the U.S. FDA, EMA, and Health Canada. Moreover, it integrates with the GCC Central Drug Registration system, providing pharmaceutical companies with a gateway to broader Gulf markets—though SFDA still requires local approval post-GCC registration.

Strategic Impact on Regulatory Professionals

For Regulatory affairs teams and consultants, the 2023 legislation serves as a definitive guide for structuring market entry and compliance strategies. It emphasizes risk-based approaches, lifecycle management, and harmonized dossier submissions—necessitating a shift from transactional registration processes to long-term regulatory planning.

Need Support Navigating SFDA Regulations?

Whether you’re preparing CTD dossiers, planning pharmacovigilance setups, or seeking licensing support, Freyr Solutions offers end-to-end Regulatory Affairs services in Kingdom of Saudi Arabia. Our in-region experts help pharmaceutical companies ensure SFDA compliance, expedite product registrations, and stay ahead of Regulatory updates.

Connect with our team to simplify your entry into the Saudi market and optimize Regulatory success across the GCC.