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Entering the Saudi Arabian market is a strategic move for any pharmaceutical company, offering significant growth potential in the Middle East. However, securing and maintaining market authorization requires strict adherence to the unique regulatory demands set by the Saudi Food and Drug Authority (SFDA).

Unlike many regions that rely solely on a global PV services in Saudi Arabia, the SFDA mandates a localized structure centered around two critical elements: the Pharmacovigilance Sub-System File (PSSF) and the Local Qualified Person for Pharmacovigilance (Local QPPV Services).

For international Marketing Authorization Holders (MAHs), successfully meeting these requirements is virtually impossible without a specialized local partner. This is where the dedicated expertise of DDReg Pharma becomes your essential guide.

???? The Pharmacovigilance Sub-System File (PSSF): A Local Cornerstone

The global standard for drug safety is the Pharmacovigilance System Master File (PSMF), which describes an MAH’s worldwide PV system. The SFDA, however, requires a localized version, the PSSF, which acts as a country-specific branch of the global PSMF.

What is the PSSF?

The PSSF is a comprehensive, living document that details all pharmacovigilance Services specific to the Kingdom of Saudi Arabia (KSA). It must:

• Describe the Local System: Outline the processes, procedures, and organizational structure for PV activities within Saudi Arabia.

• Be Maintained Locally: The physical or electronic location of the PSSF must be within KSA, and the Local QPPV must have direct access.

• Detail Local Interfaces: Document the relationships and agreements with local distributors, scientific offices, and any outsourced PV service providers.

• Focus on Local Data: Include specific details on collecting, processing, and reporting local Individual Case Safety Reports (ICSRs) to the SFDA’s Saudi Adverse Event Reporting System (SAERS).

The Localization Challenge

For multinational companies, creating a PSSF is more than just translating documents. It requires:

1. System Customization: Adapting global Standard Operating Procedures (SOPs) to align with Saudi GVP and SFDA timelines.

2. Language and Culture: Ensuring procedures account for local language (Arabic) for patient communication and local literature screening.

3. Local Expertise: The PSSF must demonstrate that the system is overseen by a locally based expert (the Local QPPV).

???? The Local QPPV: The Face of Drug Safety

The Local QPPV (L-QPPV) is the most critical compliance role in the Saudi PV system. They are the single point of contact for the SFDA on all drug safety matters and are personally responsible for the integrity and performance of the local PV sub-system.

Unique Requirements in Saudi Arabia

The SFDA’s requirements for the L-QPPV are specific and demanding, making the role difficult for MAHs to staff internally without local operations:

???? The DDReg Pharma Advantage: Specialized PV Partnership

Navigating the dual requirements of the PSSF and the Local QPPV is the primary reason international companies seek specialized PV partners. DDReg Pharma (Life Science Consulting Services )provides a comprehensive solution that seamlessly integrates with your global PV framework while ensuring iron-clad compliance with the SFDA.

Seamless QPPV Services

DDReg Pharma offers retained Local QPPV and Deputy QPPV services, immediately solving the recruitment, qualification, and residency challenges.

• Certified Professionals: Our team consists of locally registered, SCFHS-licensed medical and pharmaceutical experts who meet all SFDA requirements.

• 24/7 Availability: We guarantee continuous coverage, acting as the immediate point of contact for the SFDA, eliminating compliance risks related to availability.

• Bilingual Proficiency: Our experts ensure smooth and accurate communication in both English and Arabic, essential for handling local adverse event reports and regulatory queries.

PSSF Creation and Maintenance

We transform your global PSMF data into a compliant, SFDA-ready PSSF document.

• Expert Authoring: We author the PSSF from the ground up, ensuring every module (organizational structure, data sources, PV processes, quality system) is meticulously tailored to the Saudi Arabian GVP guidelines.

• SOP Localization: We review and adapt your global SOPs, creating localized Work Instructions that govern the collection, processing, and expedited reporting of Saudi ICSRs.

• Continuous Updates: The PSSF is a dynamic document. DDReg Pharma ensures ongoing maintenance, reflecting any changes in your organizational structure, products, or SFDA regulations.

Complete Local Support

Beyond the two central documents, a reliable PV partner covers the full spectrum of local tasks:

• Local ICSR Processing: Accurate and timely submission of local adverse event reports to the SFDA within mandated timelines.

• PV Risk Management Services: Drafting and submission of the Saudi-Specific Annex (SSA) to your Risk Management Plans (RMPs) for SFDA approval.

• Local Literature Monitoring Services: Screening local Saudi journals and publications for potential safety signals.

✅ Conclusion: Ensuring Market Integrity

The SFDA’s focus on the PSSF and a resident Local QPPV reflects a deep commitment to patient safety and localized accountability. These requirements are non-negotiable for Marketing Authorization Holders. Attempting to manage them remotely or without deep local insight often leads to compliance deficiencies, putting market access at risk.

By partnering with DDReg Pharma, you gain an immediate, compliant, and expert Local QPPV and a robust, audit-ready PSSF. This strategic alliance allows you to focus on your commercial success in the Kingdom, secure in the knowledge that your drug safety system meets the highest standards of the SFDA.

Are you ready to ensure your pharmacovigilance system is fully compliant with the SFDA’s PSSF and Local QPPV requirements? Contact DDReg Pharma to secure your local PV expertise today.