In the pharmaceutical world, ensuring patient safety is a global priority, and the Qualified Person for Pharmacovigilance (QPPV) plays a central role in this mission. However, regulatory frameworks governing the nomination and responsibilities of QPPVs vary across regions. This blog explores the differences in QPPV nomination requirements between the European Union (EU) and the Kingdom of Saudi Arabia (KSA), highlighting key regulatory procedures, expectations, and practical considerations for Marketing Authorization Holders (MAHs).

1. Understanding the Role of a QPPV

The QPPV is responsible for the establishment and maintenance of a pharmacovigilance (PV) system that ensures the safe use of medicinal products. This includes monitoring safety profiles, managing risk, and maintaining compliance with regulatory reporting obligations.

While the core responsibilities remain similar, each jurisdiction has its own legal requirements and procedural nuances when it comes to nominating a QPPV.

2. QPPV Nomination in the European Union.

Regulatory Basis:

The requirement for a Qualified Person responsible for Pharmacovigilance (QPPV) in the EU is established in Regulation (EC) No 726/2004 (Article 23 and 24) and Directive 2001/83/EC (Articles 104). These provisions state that every Marketing Authorisation Holder (MAH) must appoint a QPPV who is permanently and continuously at the disposal of the MAH, ensuring the establishment and maintenance of the pharmacovigilance system.

Key Requirements:

• Location: The QPPV must reside and operate within the EU/EEA.
• Qualifications: The QPPV must have adequate theoretical and practical knowledge of PV, medical science, and EU regulatory frameworks.
• Availability: The QPPV must be available 24/7 and have access to the Pharmacovigilance System Master File (PSMF).
• Notification: Changes in QPPV details must be promptly notified via the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD).

• XEVMPD : It is the central database where Marketing Authorisation Holders (MAHs) must register information about their medicinal products, including details of the appointed QPPV and the Pharmacovigilance System Master File (PSMF) location.

• Backup: Although not mandatory, appointing a Deputy QPPV is recommended.

• Key Responsibilities of the EU QPPV (not limited to) as per EMA GVP module 1:
• Pharmacovigilance Oversight: Ensure the MAH’s PV system is effective, compliant, and continuously operational.
• Regulatory Point of Contact: Serve as the primary contact for EU/EEA competent authorities, available 24/7.
• PSMF Management: Maintain the Pharmacovigilance System Master File (PSMF) in an up-to-date and accessible state.
• Authority and Resources: Possess sufficient authority, access, and resources to influence PV processes and decisions.
• Compliance Assurance: Guarantee timely reporting of adverse reactions, periodic safety update reports (PSURs), and other regulatory safety communications.
• Risk Management: Support the development, review, and implementation of Risk Management Plans (RMPs) and risk minimisation measures.
• Document Review: Review and approve key PV documents, including safety reports, RMPs, and regulatory responses.
• Signal Detection: Participate in the identification, evaluation, and follow-up of safety signals affecting the benefit-risk profile of products.
• Training and Culture: Promote a culture of pharmacovigilance compliance and ensure relevant staff receive proper training.
• EU/EEA Availability: Be permanently accessible and operational within the EU/EEA to ensure regulatory communication.
• Continuous Monitoring: Oversee ongoing monitoring of PV processes, audits, and corrective and preventive actions (CAPA).
• Inspections & Liability EU QPPVs are often subject to audits and inspections by the EMA or National Competent Authorities (NCAs).

3. QPPV Nomination in the Kingdom of Saudi Arabia

Regulatory Authority:

In KSA, the Saudi Food and Drug Authority (SFDA) governs PV activities under the Pharmacovigilance Guidelines for Marketing Authorization Holders (latest version “Good Pharmacovigilance Practices” GVP, version 4.0) published in August 2025.

Key Requirements (GVP V.4 module I):

• Title and Role: In KSA, the term “Local QPPV” (L-QPPV) is commonly used.
• Location: The L-QPPV must reside within Saudi Arabia and be registered with the SFDA.
•  A local QPPV must be employed one marketing authorization holder for their Pharmacovigilance system. In case the local QPPV is responsible for multiple marketing authorization holder Pharmacovigilance system, it requires a specific pre-authorized by the SFDA for shared or separate pharmacovigilance systems or may fulfill the role of QPPV for more than one pharmacovigilance system of the same marketing authorization holder provided that the QPPV can fulfill all obligations.
• Language & Communication: The QPPV must be proficient in English and Arabic to effectively communicate with local stakeholders and health authorities.
• The QPPVs should have a minimum of a bachelor’s degree in pharmacy or medicine moreover, the L QPPs should have training every two years in Pharmacovigilance, epidemiology, and must be licensed by Saudi Commission for Health Specialties
• Availability: A full-time qualified person responsible for pharmacovigilance must be available at all times and capable of responding to SFDA queries within the specified timelines.
• Registration: The nomination of an L-QPPV must be officially submitted to and approved by the SFDA NPC, along with supporting documentation (e.g., CV, experience, training certificates) through Saudi Vigilance portal (ADE)
• Backup: The SFDA mandates a full time Deputy L-QPPV to be nominated as a contingency measure, the Deputy L-QPPV preferred to be Saudi
• Key responsibilities as per SFDA regulation but not limited to:

1. Creation of the local standard operating procedures (SOPs) for handling all the pharmacovigilance activities (e.g., backup and delegation, training, handling of local ICSRs, causality assessment, seriousness, PSMF/PSSF preparation and updating files, literature review for the local journals, risk minimization measures handling, signal management per KSA specifications, and PSUR/PBRER preparation and submission per KSA specifications) to be in accordance with the regulation on the SFDA variations guidelines, and the MAH must involvethe local QPPV in all the pharmacovigilance activities.
2. Involvement of the local QPPV in the causality assessment, seriousness, submission and follow-up of the local ICSRs.
3. Having an overview of medicinal product safety profiles and any emerging safety concerns;
4. Having awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to safety or the safe use of the products
5. Having awareness of risk minimization measures.
6. Being aware of and having sufficient authority over the content of RMPs;
7. Being involved in the review and sign-off of protocols of post-authorization safety studies conducted in KSA or pursuant to an RMP agreed in KSA;
8. Having awareness of post-authorization safety studies requested by the SFDA including the results of such studies;
9. Ensuring conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and GVP;
10. Ensuring the necessary quality, including the correctness and completeness, of pharmacovigilance data submitted to the SFDA;
11. Ensuring a full and prompt response to any request from the SFDA for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product;
12. Providing any other information relevant to the benefit-risk evaluation to the SFDA;
13. Providing input into the preparation of regulatory action in response to emerging safety concerns (e.g., variations, urgent safety restrictions, and communication to patients and healthcare professionals);
14. Acting as a single pharmacovigilance contact point for the SFDA on a 24-hour basis and as a contact point for pharmacovigilance inspections.

Local Expectations

The L-QPPV is expected to:

• Monitor and report adverse drug reactions (ADRs) from the local market.
• Maintain a local PV system and ensure it aligns with the global PV framework.
• Submit periodic safety updates and ensure data traceability within Saudi Arabia.
• Participate in SFDA audits and implement corrective actions as needed.

4. Comparison Summary: EU vs. KSA QPPV Requirements

5. Key Takeaways

• Location matters: Both regions mandate local presence of the QPPV, emphasizing the importance of in-country expertise.
• Regulatory procedures differ: While the EU relies on centralized systems like XEVMPD, KSA follows a more document-based, manual approval process.
• Deputy QPPVs: KSA makes it mandatory; EU leaves it to the MAH’s discretion.
• Language & local adaptation: Cultural and linguistic requirements are essential in KSA, unlike in the EU where English generally suffices.
• Compliance focus: Both regions conduct inspections, but SFDA places unique emphasis on local data management and communication responsiveness.

Understanding the nuances of QPPV nomination in different jurisdictions ensures not only compliance but also strengthens global pharmacovigilance systems. Whether operating in the EU or KSA, aligning with local regulations is critical for maintaining product safety and regulatory trust.

Authored by Baupharma team,
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