The Safety Data Exchange Agreement (SDEA) is one of the essential pharmacovigilance requirements that the Saudi Food and Drug Authority (SFDA) mandates on the marketing authorisation holders (MAH). This document shall be signed between the MAH and other parties, such as distributors and pharmacovigilance service providers.
The SDEA rules how safety data flows between the parties, defines responsibilities and sets the timelines that must be implemented accurately. This post outlines the most important articles that this agreement must include.
The SDEA is a legal document meant to outline the obligations and responsibilities of two or more parties concerning Pharmacovigilance (PV) activities. This agreement is required to set the procedures involved in safety data collection and reporting, such as Adverse Events (AE). In addition to ensuring full compliance with other pharmacovigilance aspects.
The Safety exchange agreement can be signed between two, three, or more parties. For example:
Another example is between the MAH, the global PV service provider, and the local PV service provider.
Now that we have explained the types of the SDEA let’s go through the most critical topics to be included in this agreement:
In this section, each party should clarify their roles in delivering PV activities and how they are organisationally connected.
All the responsibilities performed by the Local Qualified Person for Pharmacovigilance (LQPPV) shall be listed here; examples may include:
This section should clarify the role of LQPPV in creating, maintaining, and submitting the local Pharmacovigilance Sub-System File (PSSF) or local PSMF.
This section should describe the reconciliation procedure in detail, such as the parties involved in the process, the type of safety information (e.g., number of ICSRs received during the month, submitted PSURs, submitted RMPs, Regulatory Authority requests, etc.), and the timelines.
To ensure compliance with SFDA timelines, signing parties should define the timelines for exchanging safety information. Examples may include:
To define each party’s responsibility in the processes related to creating the Periodic Safety Update Report (PSUR), its Saudi annexe, and the submission process to SFDA.
To define each party’s responsibility in the processes related to creating the Risk Management Plan (RMP), its Saudi annexe, and the submission process to SFDA. In addition to describing the RMP commitments’ implementation process, such as the additional Risk Minimisation Measures (RMMs).
This section should clearly describe the role of local QPPV in local and global signal management. The SFDA emphasises implementing a reconciliation procedure between the MAH and the local QPPV, including the signal detection activity outcomes. It is required even if there were no signals detected. This is in addition to including the SFDA submission timelines of the validated signals as per Saudi GVP.
To define each party’s role in the process of global & local literature monitoring as well as Regulatory Intelligence screening.
Describe the process of handling Medical Information (MI) inquiries, whether associated with ICSRs or not, in addition to identifying each party’s roles and responsibilities related to this process.
Describe the process of handling Product Quality Complaints (PQC), whether associated with ICSRs or not, in addition to identifying each party’s roles and responsibilities related to this process.
The SDEA shall describe the process of the annual PV training for the local employees who might receive safety information and the inclusion of the PV training in the induction procedures of new employees.
The SFDA requires the MAH to state in the SDEA that they have the right to audit their local PV service provider to ensure their capability of handling PV activities and compliance with local laws and regulations. Therefore, the audit process shall be described with its frequency during the contractual period.
To define each party’s responsibility during SFDA PV inspection.
Include process description of Corrective Action and Preventative Action (CAPA) and deviation management.
To include the scope of products covered by this agreement in a detailed list reflecting the generic name, brand name, and SFDA registration number.
Territories that fall under the scope of the agreement.
Addition of updated safety contact information for personnel from each party.
At the end of the SDEA, the SFDA requires adding a summary table highlighting each party’s primary roles and responsibilities.
In November 2022, The SFDA National Pharmacovigilance Center (NPC) released an updated version of the GVP that mandates MAHs to obtain SFDA pre-approval before outsourcing PV activities to a third-party service provider. The pre-approval can be obtained by submitting the SDEA to the SFDA before the appointment of the local QPPV.
Having a well-established agreement will ensure compliance with local laws and regulations. Furthermore, the topics included in this article are considered significant aspects of handling PV activities. However, MAHs should consider including other activities or areas that apply to their post-marketing surveillance activities.