Opening Doors to Saudi Arabia’s Pharmaceutical Market

Registering a drug with the Saudi Food and Drug Authority (SFDA) is a critical step for ensuring that your pharmaceutical products meet the stringent safety, efficacy, and quality standards required for the Saudi Arabian market. The SFDA enforces a rigorous regulatory framework to protect public health, and understanding these regulations is key to achieving market approval.

Key Steps in Drug Registration:

Product Classification
The first step in the registration process is determining the appropriate classification of the drug, which will guide the regulatory pathway. This includes understanding if the product is classified as a prescription drug, over the counter (OTC) drug, biological, or controlled substance.
Regulation Reference: SFDA’s Drug Registration Guidelines specify different categories and the associated requirements for each.

Dossier Preparation
A comprehensive registration dossier is required for submission to the SFDA. This dossier must contain detailed information about the drug, including:
Pharmaceutical Formulation: Ingredients and their quantities.
Manufacturing Process: Compliance with Good Manufacturing Practices (GMP).
Clinical Trial Data: Evidence of safety, efficacy, and clinical outcomes.
Preclinical Data: Toxicology, pharmacology, and stability studies.
Labeling & Packaging: Labels, inserts, and packaging that comply with Saudi regulations, including bilingual Arabic and English labeling.
Regulation Reference: SFDA’s Drug Registration Guidelines and GMP requirements.

Good Manufacturing Practice (GMP) Certification
Before a drug can be registered, manufacturers must comply with GMP standards. The SFDA requires that all manufacturing facilities—whether local or foreign—undergo an inspection to verify that the drugs are being produced in accordance with international GMP standards.
Regulation Reference: SFDA’s GMP Regulations for Pharmaceutical Products.

E-Submission via Saudi Drug Registration System (eSDR)
The drug registration application is submitted through SFDA’s eSDR System), which is an online platform for filing all documentation, including:
GMP Certificates
Clinical trial reports
Labeling and packaging materials
Market authorization requests
Regulation Reference: SFDA’s Guidelines for electronic submission.

SFDA Review & Market Authorization
Once the submission is complete, the SFDA reviews the application in two main phases:
Technical Evaluation: Assessment of the product’s safety, efficacy, and quality.
Regulatory Evaluation: Review of labeling, packaging, and compliance with Saudi market regulations.
The SFDA may request additional information or clarification, and in some cases, additional studies or trials may be required.
Upon approval, the SFDA issues market authorization, allowing the drug to be imported, distributed, and sold within Saudi Arabia.
Regulation Reference: SFDA’s Drug Registration Guidelines and Market Authorization Regulations.

Post-Market Surveillance & Reporting
Once the drug is approved and, on the market, post-market surveillance is required. This includes:
Adverse Event Reporting: Manufacturers must report any adverse reactions or product issues.
Periodic Renewals: Drugs must be periodically reviewed and renewed to ensure ongoing compliance with SFDA standards.
Compliance with Saudi Regulations: All changes in formulation, labeling, or packaging must be reported to the SFDA.
Regulation Reference: SFDA’s Pharmacovigilance Guidelines and Post-Market Surveillance Regulations.

Regulatory Framework and SFDA Guidelines

Saudi Food and Drug Authority (SFDA) Regulations: The SFDA enforces a comprehensive regulatory framework for drug registration in Saudi Arabia. The primary regulations are outlined in the Saudi Pharmaceutical Law, which covers the importation, distribution, sale, and regulation of pharmaceutical products.
SFDA Drug Registration Guidelines: Detailed instructions and requirements for the preparation, submission, and review of drug registration dossiers.
GMP Regulations: SFDA’s Good Manufacturing Practices guidelines ensure that drugs are produced in a consistent, controlled environment that meets international quality standards.

How UniFusion B.S.C. Supports Drug Registration with SFDA

Navigating the regulatory landscape of drug registration with the SFDA can be complex. UniFusion B.S.C. provides comprehensive support, ensuring your drug meets all necessary requirements for successful market entry in Saudi Arabia. Our services include:

Dossier preparation and submission
GMP certification support
Liaison with SFDA for smooth approval
Ongoing post-market surveillance assistance