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WEB-RADR 2 · Project

Drug Safety Reporting APIs That Plug Into Any Health IT System

healthPilotedTRL 7

Imagine you report a bad reaction to a medicine — that report needs to reach the right people fast. WEB-RADR 2 took an existing drug safety app and turned it into a set of building blocks (APIs) that any hospital system, pharma company, or health charity can plug into their own software. They also created a "translation layer" between the three major medical coding systems so drug safety databases can actually talk to each other. Think of it like making sure Google Translate works between the three main languages that doctors, regulators, and drug companies use to describe side effects.

By the numbers
12
consortium partners across the project
9
countries represented in the consortium
3
core healthcare terminology systems mapped (MedDRA, SNOMED, WHO)
17
total project deliverables completed
EUR 1,168,750
EU contribution to the project
The business problem

What needed solving

Pharmaceutical companies and health organizations spend enormous resources on drug safety reporting, yet their systems often cannot talk to each other because they use different medical coding standards. When a patient reports a side effect, that information needs to reach regulators, doctors, and pharma companies — but each uses different terminology databases (MedDRA, SNOMED, WHO), creating data silos that slow down safety responses.

The solution

What was built

The project delivered APIs that allow any third-party organization to embed drug safety reporting functionality into their own systems and websites. It also established technical requirements for prescriber alerts in EHR systems, delivered a platform concept for adoption by system providers and EFPIA members, created an enhanced app ecosystem for broader organizational adoption, and produced initial terminology mappings between MedDRA, SNOMED, and WHO pharmacovigilance terms.

Audience

Who needs this

Pharma companies with pharmacovigilance teams needing faster adverse event reportingEHR vendors wanting to add drug safety alerts to their systemsNational medicines regulators seeking interoperable reporting toolsHealth charities and patient organizations wanting to offer side-effect reportingClinical software providers building prescriber decision-support tools
Business applications

Who can put this to work

Pharmaceutical
enterprise
Target: Pharma companies with pharmacovigilance departments

If you are a pharma company spending significant resources on adverse event reporting — this project delivered ready-to-adopt APIs that let you embed drug safety reporting directly into your existing systems. The platform was specifically built for EFPIA member adoption, meaning it is designed for industry-grade pharmacovigilance workflows across 9 countries.

Health IT / EHR Providers
mid-size
Target: Electronic health record system vendors

If you are an EHR vendor looking to add prescriber safety alerts — this project established the technical requirements for integrating drug safety alerts directly into electronic health record systems. The API-based architecture means you can embed this functionality without rebuilding your platform, serving the 12-partner network already established.

Healthcare / Patient Safety Organizations
any
Target: Health charities and patient advocacy groups

If you are a health charity or patient organization wanting to give your community easy access to drug safety reporting — this project delivered an enhanced app ecosystem readily available for adoption by different organisations. The platform concept was designed specifically so non-technical organizations can offer reporting tools through their own websites and apps.

Frequently asked

Quick answers

What would it cost to integrate WEB-RADR 2 functionality into our systems?

The project was funded with EUR 1,168,750 under IMI2 (a public-private partnership between the EU and pharma industry). As an IMI2 project, the platform was designed for adoption by EFPIA members and regulatory authorities. Specific licensing or integration costs would need to be discussed with the coordinator (MHRA).

Can this scale across multiple countries and regulatory systems?

Yes — the consortium spanned 9 countries (CH, DE, DK, ES, HR, NL, SE, UK, US) with 12 partners. The terminology mapping between MedDRA, SNOMED International, and WHO classification systems was specifically designed to enable cross-border interoperability between regulatory and healthcare databases.

What is the IP situation — can we freely use the APIs?

This was an IMI2-RIA project involving regulatory authorities and industry partners. The deliverables explicitly mention making functionality available for adoption by EFPIA and other system providers. Exact IP terms and licensing conditions should be clarified with the MHRA as coordinator.

Does this meet current regulatory requirements for pharmacovigilance?

The project was led by the UK Medicines and Healthcare Products Regulatory Agency (MHRA), a national regulatory authority. The platform was built to support regulatory reporting workflows and includes terminology mapping aligned with MedDRA, SNOMED, and WHO standards — the three core classification systems used in pharmacovigilance.

How long would integration take?

The project ran from September 2018 to June 2020 and delivered API-based functionality specifically designed for third-party adoption. The deliverables include established technical requirements for EHR integration and a platform concept ready for adoption, suggesting the groundwork for integration is already laid out.

Can this connect to our existing pharmacovigilance or EHR systems?

That was the core purpose of WEB-RADR 2. The project converted the original app into APIs so third-party organisations can embed the functionality into their own systems, applications, and websites. The terminology mapping between MedDRA, SNOMED, and WHO further ensures data can flow between regulatory and healthcare databases.

Consortium

Who built it

The WEB-RADR 2 consortium of 12 partners across 9 countries is led by the UK's MHRA — a national medicines regulator, which gives the project strong regulatory credibility. With 4 industry partners (33% industry ratio) and 2 research organizations, the consortium leans toward practical implementation rather than pure research. The involvement of organizations from the US alongside European partners signals global applicability. Notably, the three major healthcare terminology owners (MedDRA MSSO, SNOMED International, and WHO) were involved in the mapping activity, giving the outputs direct authority in the pharmacovigilance domain. The absence of SMEs and universities suggests this is a mature, institutional effort focused on deployment rather than early-stage exploration.

How to reach the team

MHRA (Medicines and Healthcare Products Regulatory Agency), United Kingdom — a public regulatory body. Contact via their official channels or the project website.

Next steps

Talk to the team behind this work.

Want to explore how WEB-RADR 2's drug safety APIs could integrate with your pharmacovigilance or EHR systems? SciTransfer can connect you with the right people on the project team.

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