The SFDA requires international MAH to develop and maintain a pharmacovigilance sub-system file (PSSF) for the Saudi market. This file is similar to the PSMF but must reflect the local system in Saudi that the local QPPV is working within. In this post, we outline the requirements for this file.
According to the Saudi Good Pharmacovigilance Practices (GVP) Guideline, marketing authorization holders (MAHs) are required to establish a local pharmacovigilance (PV) sub-system in the Saudi market. It must be documented in a file known as the Pharmacovigilance Sub-System File (PSSF), which describes the essential requirements of pharmacovigilance activities in the KSA. This would work as a branch of their central PV system in the country of origin (PSMF).
The PSSF is a file that includes the necessary information and documentation related to performing Pharmacovigilance activities nationally in the Saudi Arabian market. The SFDA requires the Saudi QPPV to be fully responsible for the PSSF generation and maintenance. Regarding the location, the PSSF shall remain within Saudi Arabia, where the local QPPV operates. The PSSF may be supplied electronically, provided that SFDA can access a well-organized hard copy upon request.
The PSSF should include the following sections:
This section includes essential information about the QPPV’s role and responsibilities. It should cover job description, qualifications, experiences, and contact details. It should also address backup arrangements if the QPPV is unavailable for pharmacovigilance duties. Any additional information shall be included in Annex A.
The structure of the MAH’s local office for pharmacovigilance should be described. It should include details about the company, the central PV department, and the relationships between organizations and units involved in pharmacovigilance. It’s also important to mention any third parties involved. Additional information shall be included in Annex B.
In this section, the description should outline the steps of collecting safety data for authorized products in the SFDA. This should include timeframes, parties involved, and flow diagrams. It should also mention the departments or third parties responsible for collecting and reporting ICSRs. Additional information shall be included in Annex C.
The KSA PSSF should describe the computerized systems and databases used at the national level, including location, functionality, operational responsibility, and a suitability assessment. Multinational MAHs can own a database outside KSA, but the QPPV must have access to local safety cases and pharmacovigilance data online. Alternatively, a local database should be maintained in the Saudi Arabia office. Additional information shall be included in Annex D.
The PSSF should include a description of the procedural documentation available at the national level, the type of data held, and an indication of how records are archived. Any relevant information shall be added to Annex E.
Evidence of the continuous performance monitoring of the PSSF, including compliance with the primary pharmacovigilance outputs, should be included in the PSSF. More details shall be included in Annex F.
In this section, the audit schedules and list of completed and carried out audits should be included. Additional information shall be added in Annex G.
The product details covered by the local pharmacovigilance system shall be listed in “Annex H”. Also, any change or updates to the PSSF/annexes should be included in “Annex I”.
The PSSF is not submitted to SFDA routinely. Instead, the summary of KSA PSSF shall be presented within the application for new drug registration. However, there are exceptions in which full KSA PSSF and its summary are requested for submission, including but not limited to:
As mentioned, the entire PSSF file and its summary are requested in certain circumstances. However, for the marketing authorization application, only a summary of the MAH KSA PSSF is required, and it should include the following:
This article emphasizes the importance of meeting PV requirements, as the SFDA GVP guideline outlines. By implementing a comprehensive pharmacovigilance system, including the PSSF, multinational MAHs can effectively monitor and supervise medication safety within the country, ensuring compliance with local laws and regulations in Saudi Arabia.