Pharmacovigilance Agreements (PVA), also known as Safety Data Exchange Agreements (SDEA), are essential legal contracts that outline the responsibilities for pharmacovigilance activities between two or more parties.
These agreements ensure that Marketing Authorization Holders (MAH) and their partners meet legal obligations, safeguarding compliance and public safety.
In this blog post, we explore when a PVA is required, how it is drafted and managed, the key elements it should include, and its legal basis.
When is a Pharmacovigilance Agreement (PVA) required?
The MAH must establish a PVA in scenarios such as:
-
Outsourcing Pharmacovigilance Activities: When pharmacovigilance tasks are delegated to service providers.
-
Third-Party Involvement: When distribution or manufacturing is performed by external entities.
-
Licensing, Promotion, or Joint Marketing: When collaborating with other parties for these activities.
By formalizing these responsibilities, PVAs ensure seamless coordination and compliance across all stakeholders.
Drafting and managing a Pharmacovigilance Agreement
The development of a Pharmacovigilance Agreements should align with the specific type of business agreement between the involved parties. Key steps include:
-
Separate Drafting: The PVA should be created independently of the overarching business contract to allow updates when necessary.
-
Involvement of the QPPV: The Qualified Person for Pharmacovigilance (QPPV) should participate in drafting or reviewing the agreement to ensure its accuracy and relevance.
-
Robust Implementation: After finalization, the agreement should be implemented through training and documentation to ensure compliance.
-
Updating the PSMF: The Pharmacovigilance System Master File must reflect the details of the PVA to maintain regulatory alignment.
What information should a PVA include?
To be effective, PVAs must be detailed and comprehensive. Key components include:
- Contact Information: Details of the QPPV.
- Responsibilities: Clear delineation of tasks such as:
- Collection and submission of ICSRs (Individual Case Safety Reports).
- Conducting literature searches.
- Writing and submitting periodic safety reports.
- Signal detection and response.
- Handling regulatory authority requests.
- Products and Territories: Specific details about the covered products and their jurisdictions.
- Deadlines: Explicit timelines for data exchanges and responsibilities.
- Review Frequency: Defined intervals for reviewing and updating the agreement.
Legal basis for Pharmacovigilance Agreements
The foundation of PVAs lies in the guidelines provided by Module VI of the Good Pharmacovigilance Practices (GVP). These guidelines cover:
-
Data Collection and Management: Processes for handling suspected adverse reactions.
-
Reporting Requirements: Obligations for both serious and non-serious adverse reactions for medicinal products in the EU.
For detailed guidance, refer to GVP Module VI.
关于作者
Senior Drug Safety Officer at QbD Group
Soraia is a Senior Drug Safety Officer at QbD Group, managing pharmacovigilance activities and ensuring compliance with global safety reporting requirements.
Strengthen Your Pharmacovigilance System
QbD Group offers a full range of pharmacovigilance services to ensure your products meet compliance standards while safeguarding patient safety.
Read more订阅生命科学领域的最新动态
专家观点直达您的收件箱——选择您的兴趣。
绝无垃圾邮件。随时取消订阅。
