With the EU Regulation 2025/1466 Key requirements for the Pharmacovigilance (PV) Noticeably, the focus is shifting away from pure formalism towards Traceability, process quality and transparent documentation. For pharmaceutical companies, this means specifically: PV processes must not only function, but proven, versioned and auditable be, and that is along the entire process chain from detection to action. 

This increases expectations for the organization, IT systems, and governance alike. In particular, the following are required: 

• Complete documentation of PV-relevant content and decisions 

• Risk-based assessment of deviations and process risks 

• Rapid response to potentially critical messages 

• international data standards and consistent chains of evidence 

• Audit and inspection capability for internal and regulatory audits 

evalii® It provides the technological and procedural foundation for this. The platform supports companies not only in meeting regulatory requirements, but also in... to actively control. 

 evalii® is a structured system for monitoring, evaluation and Documentation of potentially pharmacovigilance-relevant content, especially from digital channels. This is precisely where a practical problem often lies: While companies can often monitor social media, contact forms, or platform comments, the regulatory-required documentation is often manual, fragmented, and not consistently audit-proof. 

evalii® provides a solution here by handling all process steps standardized and understandable be depicted. 

The platform helps answer key audit questions such as: 

• Which message was detected and when? 

• How was it evaluated, classified, and prioritized? 

• To whom was it forwarded and when? 

• Who was involved and what measures were taken? 

This creates a transparent, audit-proof workflow, which can be adapted to existing role models and SOPs. 

 The new EU regulation reinforces the requirement that PV processes not only be "lived" but also formally verifiable must be. In practice, this means that companies need documented proof that..., 

• that PV-relevant content identified become, 

• like her rated become, 

• how decisions are made, 

• and which Measures were hit. 

With evalii®, this documentation no longer becomes a manual effort.  

This particularly supports: 

Compliance with new PSMF (Pharmacovigilance System Master File) requirements 

The demands placed on the PV system and its documentation are increasing. evalii® enables the consistent mapping of process logic, responsibilities, and decision-making paths – an essential foundation for auditable PV documentation. 

Risk-based assessment of process deviations 

Instead of blanket formalism, risk-based analysis takes center stage: Which deviations are critical? Which are tolerable? What measures are required? evalii® provides structured data foundations for this. 

Audits require a complete and transparent justification of decisions and responsibilities. evalii® provides a comprehensive history for this purpose: Who assessed what, when, and why? This reduces audit effort and provides security when dealing with regulatory inquiries. 

Digital channels are now a key risk factor and, at the same time, a crucial information space. Continuous monitoring is therefore not only an organizational obligation but increasingly a governance requirement: companies must ensure that relevant content is identified and assessed before it gives rise to regulatory or liability risks. 

evalii® offers not only safety, but a genuine Early warning function: 

• Potentially critical content is identified. 

• prioritized and classified 

• assigned to the relevant authorities 

• and documented along the process chain 

This creates responsiveness – and at the same time the required verifiability. 

 Conclusion:  

The new EU regulation requires transparency, reaction speed and documented quality. Companies are therefore faced with the task of not only making PV processes more efficient, but above all Auditable and revision-proof to build. 

evalii® offers a solution that meets regulatory requirements structured representation, Effort reduced and supports companies in implementing modern PV standards. 

With evalii®, the switch to... modern pharmacovigilance. 

In digital communication, the principle of "proximity creates responsibility" is truer than ever. Healthcare companies also benefit enormously from channels like Instagram, WhatsApp, and Facebook, but they must also face regulatory realities. As soon as users post publicly, the company becomes (partly) responsible, at least in certain areas.

Whether it's a personal account, a recommendation, or even a medication name – what seems authentic and harmless can become legally problematic. This is especially true in the context of the German Act on Advertising of Therapeutic Products (HWG).) and internal communication guidelines.

Many users describe their personal medical histories online – often combined with promotional and comparative statements.

However, depending on the context, such statements may violate Section 11 of the German Advertising Act (HWG) or general competition law provisions – especially if:

• Specific products will be mentioned.
• Disease progression or treatment successes are described.
• Acknowledgements or recommendations are given

Even if the content originates from a third party, companies are obligated to moderate or remove it as soon as they become aware of it. Furthermore, companies must ensure they can regularly access such content. Otherwise, the statement could be attributed to them.

And this is exactly where evalii® comes into play: as a tool for all digital communication.

evalii® is far more than a pharmacovigilance monitoring system: Incoming content can not only be checked for potential adverse event reports, but also for:

• HWG-critical statements
• Violations of netiquette guidelines
• problematic comment types such as misinformation or sensitive content

As soon as relevant content is detected, a report is also issued here following a coordinated process:

• Either through our team: We review, evaluate and act according to your specifications.
• Or through your internal department/agency: evalii® immediately sends an email notification to the responsible person.

This way you can decide individually who moderates, but you won't miss any comments.

Why this matters to you:

• Greater security in the digital space – even with high interaction and high volume of comments

• Early warning system for potential violations of the German Medicines Advertising Act (HWG) – Risks become immediately visible
• Proactive moderation reduces legal risks and protects against escalations or shitstorms
• Audit-proof documentation of all incidents – traceable and verifiable at any time
• Seamless integration into existing SOPs, role models and internal processes – evalii® adapts to your organization

 

While other tools stop at PV notifications, evalii® ensures comprehensive communication security – from social media to messengers to web forms.

Your users are allowed to communicate. And you retain control.

Image: © Adobe Stock / 1518317541