Why Medical Information Is Central to MAH Compliance, Access, and Patient Safety – Identifying Reportable Information

February 19, 2026

Customer service professional wearing headset asking coworker a question

Inquirers rarely contact Medical Information (MI) to report an adverse event (AE), special situation event (SSE), or product quality complaint(PQC). They call because they have a question, but collecting this data is imperative for Marketing Authorization Holders (MAHs). While obvious AEs, such as "I used your medicine and experienced a headache" are straightforward to recognise and capture, other situations are far more nuanced. Special situations, unexpected benefits, and product complaints can be difficult for patients and even healthcare professionals (HCPs) to identify as reportable.

This is exactly why the MI function plays such a critical role in maintaining compliance. MI becomes the place where these signals can surface.

Medical Information as a Trusted, High-Quality Front Door

MI services should always, without exception, answer inquires reliably, quickly, and without bias. MI ProPharma teams consistently achieve exceptional responsiveness — often exceeding 90% of calls answered within 20 seconds. This prompt and easy access builds trust, encouraging customers to keep coming back and prevents them from turning to less reliable sources, such as automated bots or non-validated AI tools.

With this relationship built upon trust, when an inquiry reaches a trained MI specialist, the conversation becomes richer and more open. This trust enables MI teams to identify underlying AEs, SSEs, or PQCs that the caller may not have recognised as important or reportable to the MAH.

Capturing What HCPs Don't Have Time to Report

HCPs are busy. They do not always have time to submit a formal AE or PQC report — especially for events already described in the label. However, it remains critical for MAHs to capture all safety information to maintain pharmacovigilance obligations and protect patients.

MI acts as a practical, accessible route for this information to come through. When HCPs contact MI with their questions, highly trained specialists can explore the rationale behind the inquiry, uncovering the true clinical context. Often, the information shared is linked to an AE or product complaint that might otherwise have gone unreported.

Turning Inquiries into Insights

MI occupies a unique position within the MAH responsibilities. MI specialists speak directly with patients, caregivers, and HCPs — those using the products in real-world settings. This visibility creates a powerful feedback loop.

Because MI handles large volumes of inquiries, teams can identify:

  • Emerging trends in inquiry types
  • Areas where users struggle with administration or adherence
  • Misunderstood elements of the label
  • Opportunities to enhance educational materials
  • Potential early safety or quality signals

These insights strengthen both compliance and patient support strategies. They inform cross-functional decisions and help MAHs proactively improve how medicines are used in practice.

The Case for Medical Information as a Strategic Asset

MI is far more than a responsive service desk. It is acritical safeguard for patient safety, a key partner in compliance, and a strategic listening post for the MAH. Every inquiry is an opportunity to identify safety signals, to capture essential reportable data, and to understand the real-world challenges faced by patients and HCPs.

In an environment where trust, accuracy, and speed matter more than ever, MI remains one of the most reliable, human-centred ways to ensure medicines are used safely and effectively. And as the industry evolves, the insights generated through MI will continue to guide smarter decisions, improve patient outcomes, and reinforce the MAH's commitment to quality and safety.

Speak to Our Medical Information Experts

If you would like to strengthen your MI function or ensure your processes fully support pharmacovigilance and compliance obligations, our MI experts are here to help. Contact our team to discuss how we can support your organisation with compliant, high-quality, insight-driven medical information services.

Author

Hannah Hunter

Hannah Hunter

Senior Director, Medical Information

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