The Saudi Food and Drug Authority (SFDA) has published Version 4 of the Registration Rules for Pharmaceutical, Herbal, and Health Product Manufacturers and their Products, establishing updated regulatory frameworks for the registration and oversight of manufacturers and their products. These rules, approved by the Registration Committee of Manufacturers of Pharmaceuticals and their Products, are grounded in Article 20/4 of the Implementing Regulations of the Law of Pharmaceutical and Herbal Establishments and Products. The updated rules aim to strengthen regulatory governance, enhance local manufacturing, and ensure product quality, safety, and efficacy across pharmaceuticals, herbal remedies, and health products.

Key Definitions

• Pharmaceutical Product: Manufactured medicines used to prevent or treat diseases.
• Biological Product: Products derived from biological sources or biotechnology (e.g., vaccines, recombinant proteins).
• Generic Product: Equivalent to innovator products in dosage, strength, and therapeutic effect.
• Herbal Product: Plant-based medicines manufactured in pharmaceutical form.
• Health Product: Low-risk products used to maintain or improve health.
• Growing Local Manufacturer: A facility with an industrial license, recognized as “growing” for up to three years after its first product registration.
• Conditional & Tentative Approvals: Mechanisms to allow temporary or conditional market access under defined circumstances.

Manufacturer Registration Requirements

1. A valid GMP certificate or equivalent proof of compliance issued by the regulatory authority in the country of origin.
2. A complete list of manufactured products, including contract-manufactured items.
3. Copies of registration certificates from countries where products are marketed.
4. Site Master File and details of production lines.
5. Payment of inspection fees.
6. Acknowledgement of publishing the Committee’s decisions.

Renewals: Applications must be submitted at least six months before expiry, accompanied by updated GMP certification, product lists, and inspection fees.

Product Registration Rules

Imported Products

• Must be registered and marketed in the country of origin.
• If not, justification and a CPP/FSC from an SRA are required.
• Exceptions may apply for critical or necessary drugs.

Reliance Pathways

SFDA may rely on assessments from Stringent Regulatory Authorities (SRAs) (e.g., USFDA, EMA, MHRA, PMDA, TGA) for product approvals and post-marketing safety surveillance decisions.

Contract Manufacturing

• When advanced technology is not locally available.
• For innovative or critical generic products.
• If one of the contracting companies is a local entity.

Under-License Manufacturing

Foreign companies may authorize local or other foreign firms to manufacture and market their products under license, subject to strict conditions, continuity of supply obligations, and regulatory oversight.

Additional Regulatory Highlights

• Distribution Classification: Products are categorized as prescription-only, controlled, pharmacist-only, or OTC, with defined distribution channels (pharmacies, hospitals, or retail).
• Pharmacovigilance: Marketing Authorization Holders (MAHs) must comply with SFDA’s Good Pharmacovigilance Practices.
• Patient Information: Products must include PILs (Arabic & English) and SPCs (English), uploaded to the Saudi Drug Information (SDI) platform.
• Conditional/Tentative Approvals: May be granted where immediate market access is justified but full technical requirements are pending.
• Transparency: SFDA will publish scientific evaluation reports post-registration and may publicly disclose results of out-of-specification market samples.

Why This Matters for Industry

• Reinforce the importance of GMP compliance and inspections.
• Expand reliance and under-license opportunities.
• Support local industry growth while ensuring public health safeguards.
• Offer flexibility through conditional and tentative approvals, expediting access to critical medicines.