PV Outsourcing Strategies Under New EU and UK Guidelines

Pharmaceutical companies are legally required to collect, analyse, and report safety data about their medicines. This includes:

• Patient reportsof side effects
• Safety updates from all data sources
• Scientific literature reviewsfor new safety concerns
• Aggregate reportsthat summarize the benefits and risks of the product portfolio
• Review of safety data from Health Authority Databases

Doing all of this in-house requires specialized staff, systems, and 24/7 availability of PV experts. Instead of building these capabilities internally, many companies outsource PV activities to expert service providers.

Outsourcing helps:

• Reduce operational costs by leveraging external resources
• Access specialized expertise (like EU/UK Qualified Persons for Pharmacovigilance, known as QPPVs)
• Ensure compliance with evolving global regulations and maintain robust PV systems

Two big regulatory updates are driving change

1. EU Regulation 2025/1466 (Effective February 2026)
   • Updates on how companies must maintain the Pharmacovigilance System Master File (PSMF), the central record of their safety system
   • Requires stronger oversight of third-party vendors.
   • Demands an overview of the EudraVigilance database (the EU’s central database) for signal detection for all authorised molecules
2. UK regulation (post-Brexit framework)
   • Products previously authorized via the EU centralized procedure are now licensed UK-wide under MHRA requirements
   • Companies must navigate these parallel EU and UK regulations, integrating MHRA guidance into their pharmacovigilance operations to maintain compliance
   • Demands an overview of the EudraVigilance database (the EU’s central database) for signal detection for all authorised molecules
3. UK Clinical Trial Safety Reforms (Effective April 2026)
   • Changes how safety is reported for clinical trials of investigational medicines (CTIMPs).
   • Stricter timelines for reporting serious adverse events (known as SUSARs).
   • New expectations for annual safety reports and ongoing monitoring.

These changes mean companies must invest more time, resources, and attention in PV. For many, outsourcing is the most practical solution.

1. Strengthening the PSMF and QPPV Role

The PSMF serves as a company’s “safety manual.” Regulators can request it at any time, and it must always be up to date. From 2026, only major or critical issues need to be documented, but the file must still be audit-ready.

Outsourcing strategy: Partner with a service provider like Sciom that offers PSMF maintenance and experienced QPPVs in the EU and UK.

2. Oversight of Third-Party Vendors

Both EU and UK regulators emphasize that the Marketing Authorization Holder (MAH) is responsible for the quality of all safety work—even if tasks are subcontracted.

Outsourcing strategy: Use an expert partner to manage Safety Data Exchange Agreements (SDEAs) and provide vendor oversight services, ensuring compliance across the supply chain.

3. Case Processing and Safety Reporting

Every adverse drug reaction (ADR) report must be reviewed, coded, and submitted within strict deadlines. For global companies, this often means 24/7 case processing.

Outsourcing strategy: Delegate ICSR processing to experienced teams who use validated systems to ensure accuracy and timeliness.

4. Signal Management

Regulators expect companies to monitor for safety signals—patterns that suggest new risks. From 2026, EudraVigilance (the EU’s central database) will be more central to this process.

Outsourcing strategy: Collaborate with specialists who can handle signal detection, periodic safety reports (PSURs), and risk management plans (RMPs).

5. Aggregate Reports

Medical and scientific writing includes the preparation of key regulatory documents such as PSUR/PBRER, AdCO, and Risk Management Plans (RMPs). Regulators provide zero noncompliance to such documents, and it requires scientific expertise.

Outsourcing strategy: Engage experienced pharmacovigilance outsourcing partners who offer medical and scientific writing services. At Sciom, our team prepares and maintains these critical documents in full compliance with EU and UK regulatory expectations, ensuring clarity, consistency, and scientific accuracy.

6. Literature Monitoring

ublished literature often contains early warnings of safety issues. Regulators require companies to search medical journals regularly and update safety documents accordingly.

Outsourcing strategy: Partner with PV providers who offer literature monitoring and regulatory writing services for reports like PSURs and DSURs.

7. Regulatory Intelligence

Regulatory Intelligence helps companies stay ahead of global pharmacovigilance requirements by monitoring regulations, interpreting updates, and providing actionable insights. It ensures compliance, supports decision-making, and enables proactive planning for safety and risk management.

Outsourcing strategy: Partnering with an experienced pharmacovigilance service provider like Sciom ensures continuous monitoring of EU, UK, and international PV regulations. Sciom’s experts interpret new guidance, assess its impact on your processes, and provide actionable insights so your organisation can remain fully compliant and future-ready.

At Sciom Ltd, we combine experienced pharmacovigilance professionals with AI- and NLP-enabled tools to deliver comprehensive PV outsourcing services fully aligned with global regulations, including the latest EU and UK requirements.

Our capabilities include:

• EU QPPV/ LPPV and UK QPPV/NCP services
• PSMF and SDEA management
• Scientific and Regulatory Writing
• ICSR management using a validated safety database, powered by AI/NLP and PV expertise
• Signal detection with an AI-driven tool with real-time insights alongside PV experts
• Global and local literature screening leveraging AI/NLP alongside expert review
• Regulatory Intelligence leveraging AI/NLP alongside expert review