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Author: Avinash Dhawade and Tushar Patil

Understanding Safety Data Exchange Agreements

Understanding Safety Data Exchange Agreements

The Safety Data Exchange Agreements (SDEAs) are legal written contracts that require business partners to exchange all safety data for medicinal products with Marketing Authorization Holders (MAHs). This in turn ensures that the legal obligations are fulfilled by the MAHs.

The SDEAs are developed by two or more parties working together. The detailed responsibilities of each party regarding pharmacovigilance activities, including timelines and regulatory obligations, are explained within the SDEAs. It is important to ensure that these agreements are well defined to ensure regulatory compliance. The SDEAs are typically reviewed during audits and inspections to ensure that the shared nature of the agreement is well documented and that all parties have given their approval.

Background & Scope

The Marketing Authorization Holders (MAHs) cannot have affiliates, subsidiaries, or vendors in each country where they hold medicinal product licenses. It is not cost-effective, and sometimes local regulations do not permit such arrangements. Hence, there is a need for Safety Data Exchange Agreements (SDEAs) between the entities so that MAHs can fulfill their legal obligations.

There is a wide variety of agreements and collaborations that MAHs can get into. There may be no pharmacovigilance activities or any contact between contractual partners and healthcare providers (HCPs) or patients. However, these contractual partners are a potential source of safety information, and hence the exchange of this information with MAHs becomes critical.

An SDEA must be in place when a MAH enters into research, product distribution, licensing, or other marketing agreements with a third-party organization or when pharmacovigilance activities are outsourced to a service provider.

The SDEA may be executed between MAH and:

  • Service provider company
  • Manufacturing site
  • Distributor
  • Affiliate/subsidiary
  • License partner
Regulatory References

GVP Module I - Pharmacovigilance systems and their quality systems

As per module I guidelines, if a marketing authorization holder has a plan to expand its product portfolio (e.g., acquisition of a new company or individual product purchase), a Qualified Person for Pharmacovigilance (QPPV) should be notified on a priority to assess the impact on pharmacovigilance activities. A QPPV needs to understand the detailed sections within a contractual agreement to determine what kind of safety information to request from other companies.

GVP Module VI - Guideline on good pharmacovigilance practices (GVP)

The GVP module VI mandates detailed contractual agreements and procedures between the marketing authorization holder and a person or organization to fulfill compliance with the submission of valid Individual Case Safety Reports (ICSR) within appropriate timeframes. These procedures should specifically outline the mechanisms for exchanging safety data, as well as the schedules and responsibilities for submitting valid ICSRs to the regulatory authorities in the respective territory.

US FDA CDER webinar - Post-marketing drug safety and inspection readiness

As per the webinar conducted by the Center for Drug Evaluation and Research (CDER), business partners are one of the most critical sources of safety data, and thus, marketing authorization holders must establish written agreements with them to exchange safety data.

Inspection Purview

  • What data gets exchanged?
  • Timelines to exchange the data.
  • Reconciliation measures.
  • Point of contact details.
  • Adequate governance procedures.
  • Regulatory submission responsibilities.
  • Defined responsibilities for late submissions and RCA/CAPA provisions.
SDEA Content

The SDEA includes or covers, but is not limited to, the following aspects:

  • References to Master Service Agreements (MSAs)
  • Definition, terminology, acronyms
  • The process of safety data exchange
  • Products and territory of agreement
  • Safety database holder
  • Mode of communication
  • Exchange of literary information
  • Exchange of ICSR (serious, non-serious) and other safety information with timelines
  • Exchange of aggregate reports
  • Reconciliation process
  • Pharmacovigilance management system
  • Details of the point of contact of all involved parties
  • Regulatory compliance
  • Audits and inspections
  • Data privacy and confidentiality clauses
  • Business continuity plan details
  • Termination clauses

Safety Data Exchange Agreements (SDEAs) play an important role in Pharmacovigilance systems. These agreements clearly define the roles and responsibilities of various partners to fulfil regulatory obligations. This also helps prevent the submission of duplicate reports to the regulatory authorities. Therefore, MAHs should ensure that the SDEAs are part of their Quality Management System and audit/inspection-ready at all times.

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