Few tools are as essential when protecting patients as a drug safety database. Also known as a pharmacovigilance database, this system is the backbone of how the pharmaceutical industry and regulatory authorities track, analyse, and prevent risks linked to medicines.

But what exactly is inside a drug safety database? And why does it matter so much for patient safety and compliance? Let’s dive in.

Why Drug Safety Databases Exist

Every medicine on the market carries potential risks. That’s why reports of adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), and pregnancy cases are carefully collected.

During clinical trials, sponsors gather suspected ADRs and SUSARs. After approval, patients and healthcare professionals (HCPs) report real-world side effects to either the regulatory authorities or the marketing authorisation holder (MAH).

In short, a safety database is the central truth repository for all drug-related risks.

How Patients and Professionals Report Events

Reporting an adverse event is surprisingly simple. Patients and HCPs can submit cases in minutes using forms like CIOMS I, MedWatch, Yellow Card or online forms on national authority websites.

These reports can be sent via email, online portals, or traditional mail. The information then flows into detailed drug safety databases that regulators and pharmaceutical companies manage.

From Forms to Databases: How Data Is Collected

While an individual report may look like a short form, regulators and companies transform it into structured data. Sometimes, it’s recorded in a simple Excel sheet. More often, though, it’s stored in specialised pharmacovigilance database software.

Legally, both regulators and pharma companies must record every report. This is not optional – it’s required by law across the EU, US, and most global markets.

Case Processing and Regulatory Oversight

Companies must prove that a medicine’s benefits outweigh its risks to stay on the market. That’s why adverse events need to be collected, processed, and analysed continuously.

• Pharma companies maintain databases for their own products.

• Regulatory authorities oversee safety across all medicines in the country.

• Global requirements often mean companies must submit cases from other countries, too.

The result? Every country has at least one national safety database, while each pharmaceutical company maintains its own.

The Goal of Safety Data Collection

Ultimately, a drug safety database aims to allow sponsors, pharma companies, and regulators to analyse medicines’ risk–benefit profile. This ensures treatments help more than they harm.

What Makes a Safety Database Different

Unlike general-purpose databases, a safety database must follow strict rules set by the International Council for Harmonisation (ICH).

The data is structured according to international standards – either E2B R2 (the older version) or E2B R3 (the newer standard used, for example, across the EU).

This harmonisation ensures that safety data can be exchanged worldwide. In practice, reports are shared in XML format, almost interchangeable with an Individual Case Safety Report (ICSR) in pharmacovigilance.

Why XML Matters

The XML format ensures data can move seamlessly between:

• Pharmaceutical companies and regulators

• National authorities and international bodies like the EMA

• Private organisations such as CROs and sponsors

Safety databases must be able to generate and import XML files, making them the lifeline of pharmacovigilance communication.

DrugCard Redefines Safety Databases

Traditional drug safety databases often come with high license fees, limited user seats, and rising costs the more you work with them.

DrugCard takes a different approach. Our AI-powered adverse event database is designed to support teams, not restrict them. We keep things simple with three clear principles:

Fair, fixed pricing – choose monthly, quarterly, or yearly billing with no hidden costs.

Unlimited users – give everyone on your team access without extra fees.

Unlimited cases – manage as many reports as needed without penalties.

With this transparent model, you can forget about financial roadblocks and focus on what really matters – keeping patients safe.

Why Unlimited Really Matters

Unlimited access changes the way safety teams work.

Unlimited users mean no tough choices about access. Sponsors, QPPVs, PV specialists and medical reviewers can all collaborate in one system. Training becomes simpler since everyone works with the same interface.

Unlimited cases mean every report can be captured without hesitation. Even during reporting spikes, your costs stay predictable. No more second-guessing about duplicates or borderline cases – everything is recorded.

The result? Case management that’s faster, smoother, and fully compliant.

Conclusion

A drug safety database is more than software – it’s the foundation of pharmacovigilance. Capturing and analysing adverse event data helps protect patients and ensures medicines remain safe and effective.

With DrugCard’s AI-powered safety database, the future of pharmacovigilance is smarter and fairer.

So, if you’re ready to simplify your safety data management, explore how DrugCard can transform your pharmacovigilance system today.