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The pharmaceutical product registration in KSA is crucial for companies aiming to access one of the most dynamic pharmaceutical markets in the Middle East. The Kingdom of Saudi Arabia (KSA) has emerged as a significant hub, with the Saudi Food and Drug Authority (SFDA) being the key regulator for Saudi Arabia pharmaceutical regulations. Companies looking to distribute pharmaceutical products must navigate a highly structured and compliant to SFDA registration process.
Understanding SFDA’s Role
The Saudi Food and Drug Authority (SFDA) oversees the quality, safety, and efficacy of all pharmaceutical products in Kingdom of Saudi Arabia. Their guidelines are aligned with international standards to ensure public health protection and Regulatory compliance. Adherence to KSA drug Regulatory requirements is vital for companies to successfully market their products in the region and obtain SFDA marketing authorization.
Product Classification and Submission Dossier
Before initiating registration, the products must be classified as prescription drugs, over-the-counter (OTC) medications, biologics / biosimilars. herbal medicines, cosmetics / Medical device and supplies / combination and borderline products. The classification impacts the required documentation for SFDA dossier submission. The classification can be cone on e-Product Classification System (PCS) website (https://pcs.sfda.gov.sa/Default.En.aspx )
The SFDA mandates the Common Technical Document (CTD) format:
- Module 1: Regional administrative information
- Module 2: Common Technical Document Summaries
- Module 3: Quality
- Module 4: Non-clinical study reports
- Module 5: Clinical study reports.
Few documents (e.g., labels / PI / IFU) should be translated into Arabic, aligning with Saudi Arabia pharmaceutical regulations.
The Registration Process
- Pre-submission consultation: Companies can seek scientific advice to clarify SFDA marketing authorization requirements.
- Application submission: Complete the SFDA dossier submission via the electronic portal and pay the Health Agency fees.
- Administrative and technical review: The SFDA thoroughly reviews documents for compliance with KSA drug Regulatory requirements.
- GMP inspection and pricing evaluation: Companies may undergo a GMP inspection in Saudi Arabia to verify compliance.
- Final approval: Successful applicants receive SFDA marketing authorization to commercialize the product.
Key Considerations for Successful Registration
- Local representative for SFDA registration: Foreign companies must appoint a Saudi-licensed agent to handle Regulatory submissions and communications.
- Labeling compliance: Ensure that all labels and leaflets follow Saudi Arabia pharmaceutical regulations and Arabic language requirements.
- Pharmacovigilance system: A local system and a Qualified Person for Pharmacovigilance (QPPV) must be established within Kingdom of Saudi Arabia.
Conclusion
For a smooth pharmaceutical product registration in Saudi Arabia, companies must carefully follow the SFDA registration process and fulfil KSA drug Regulatory requirements. Partnering with Regulatory experts familiar with SFDA dossier submission and GMP inspection Saudi Arabia requirements can streamline compliance and accelerate your product’s market launch.
Looking to simplify your pharmaceutical product registration in Saudi Arabia?
With constantly evolving Saudi Arabia pharmaceutical regulations, understanding the SFDA registration process can be challenging. Our team of Regulatory experts specializes in pharmaceutical product registration in Kingdom Saudi Arabia, helping you meet compliance requirements, accelerate approvals, and secure your place in the KSA market.
