SDEA/PVA Management

Overview

Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) are critical for defining how safety information is exchanged and managed between Marketing Authorization Holders, manufacturers, distributors, license partners, service providers, and other organizations involved in pharmacovigilance activities.

Mediature GxP Solutions Pvt. Ltd. (MGS) supports organizations with drafting, review, revision, negotiation support, implementation, tracking, reconciliation, and lifecycle maintenance of SDEAs and PVAs.

Our approach focuses on clear allocation of roles, reporting timelines, case exchange, literature responsibilities, regulatory reporting, reconciliation, product scope, contact details, escalation pathways, and governance to help reduce gaps and ambiguity in pharmacovigilance responsibilities.

Our SDEA / PVA Services

Agreement Drafting

Preparation of SDEAs and PVAs tailored to the roles, products, markets, and pharmacovigilance responsibilities of the involved parties.

Agreement Review

Detailed review of existing or proposed agreements to identify unclear responsibilities, missing requirements, inconsistent timelines, or operational gaps.

Roles & Responsibility Mapping

Definition of responsibilities for activities such as:

• Case intake
• ICSR processing
• Medical review
• Regulatory reporting
• Literature monitoring
• Signal management
• Aggregate reporting
• Risk management
• Reconciliation
• Regulatory communication
• Record retention

Safety Data Exchange Requirements

Definition of what safety information must be exchanged, in what format, through which route, and within what timeline.

Case Exchange Timelines

Support for defining operational timelines for exchange of:

• Serious cases
• Non-serious cases
• Initial reports
• Follow-up information
• Literature cases
• Pregnancy reports
• Special situations
• Regulatory authority information

Product Scope Management

Support for defining the products, active ingredients, territories, markets, and business arrangements covered by the agreement.

Contact & Escalation Management

Establishment of primary and backup pharmacovigilance contacts, communication routes, escalation pathways, and responsibilities during absence or emergencies.

Regulatory Reporting Responsibility

Clear definition of which party is responsible for submission to applicable regulatory authorities and which party provides supporting safety information.

Reconciliation Requirements

Definition of periodic reconciliation processes to confirm that all relevant safety cases and exchanged information have been accounted for.

Agreement Tracking & Maintenance

Support for agreement inventories, effective dates, review dates, amendments, product updates, contact changes, and renewal requirements.

Key SDEA / PVA Elements

Depending on the business relationship, MGS may support inclusion or review of:

• Purpose and scope
• Definitions
• Parties and responsibilities
• Product list
• Territory
• Marketing Authorization Holder status
• Manufacturer role
• Distributor or license-partner role
• Pharmacovigilance contacts
• Case exchange
• Reporting timelines
• Case formats
• Seriousness assessment
• Follow-up information
• Literature monitoring
• Signal management
• Aggregate reporting
• Risk management
• Regulatory authority requests
• Product complaints with safety information
• Special situations
• Pregnancy exposure
• Reconciliation
• Audit rights
• Training
• Record retention
• Confidentiality
• Data protection
• Escalation process
• Business continuity
• Agreement review
• Amendments
• Termination responsibilities

Our Approach

• Understand the Relationship

Review the business arrangement, party roles, product ownership, territories, and existing pharmacovigilance responsibilities.

• Map Responsibilities

Clearly define who performs each PV activity and who retains regulatory accountability.

• Define Exchange Requirements

Establish safety-data types, timelines, formats, routes, contacts, and escalation pathways.

• Draft or Review

Prepare or assess the agreement for completeness, operational practicality, and consistency.

• Implement

Support communication of responsibilities, contact setup, trackers, reconciliation processes, and operational handover.

• Maintain

Support periodic review, amendments, product changes, contact updates, responsibility changes, and lifecycle tracking.

Typical Deliverables

Depending on scope, MGS can provide:

• Draft SDEA
• Draft PVA
• Agreement review comments
• Roles and responsibilities matrix
• Safety-data exchange matrix
• Reporting-timeline matrix
• Product list annexure
• Contact-person annexure
• Escalation matrix
• Reconciliation requirements
• Agreement tracker
• Amendment support
• Periodic-review support
• Implementation checklist

Why Choose MGS

Operational PV Perspective

MGS reviews agreements from the perspective of how pharmacovigilance activities will actually be performed.

Clear Responsibility Definition

Our focus is on reducing ambiguity regarding MAH, manufacturer, distributor, license partner, and service-provider responsibilities.

Timeline-Focused Approach

Safety-data exchange timelines are structured to support downstream regulatory reporting obligations.

Agreement & Process Integration

SDEA/PVA requirements can be aligned with SOPs, case workflows, database processes, reconciliation, and reporting activities.

Lifecycle Support

MGS can support agreements from initial drafting through revision, implementation, periodic review, and amendment.

Who We Support

MGS can provide SDEA / PVA Management support for:

• Marketing Authorization Holders
• Pharmaceutical manufacturers
• License partners
• Distributors
• Importers
• Exporters
• CROs
• Pharmacovigilance service providers
• Product partners
• Organizations entering new commercial or licensing arrangements