Understanding the EMA's transition to web-based application forms

In February 2025, the European Medicines Agency (EMA) announced that its web-based electronic Application Forms (eAF) are now available for variations to the terms of marketing authorisations for medicinal products for human use authorised via the mutual recognition procedure (MRP), decentralised procedure (DCP), and national procedure (NAP).

While use of the web-based forms is currently optional and the interactive PDF eAF remains available, the EMA is strongly encouraging applicants to begin using the new forms as soon as possible.

Why web-based eAFs?

The EMA first introduced the web-based eAF in November 2022, initially for centrally authorized products (CAPs). This marked the beginning of a broader push to modernize regulatory submissions and improve the application process across the EU pharmaceutical sector.

This transition reflects the EMA’s intent to align regulatory tools with modern technology. The current Adobe PDF-based eAFs, though widely adopted, are increasingly outdated and limited in their ability to support future requirements.

By transitioning to a web-based format, the EMA aims to improve usability, reduce errors, and better integrate with other digital systems used by industry stakeholders. This is part of a wider strategy to ensure regulatory platforms are robust, efficient, and future-ready.

What are the benefits of web-based eAFs?

The new eAFs are designed to significantly enhance usability for both applicants and regulatory authorities. One of the key improvements is the introduction of smart features, such as the ability to prepopulate form fields with available data. This functionality not only accelerates the completion process for applicants but also reduces the likelihood of manual entry errors and inconsistencies.

For regulatory authorities, the web-based forms represent a step forward in streamlining application processing. By reducing administrative workload and minimizing common issues, such as data discrepancies or missing information, the new system supports more efficient review and decision-making workflows.

In terms of output, the forms maintain support for the familiar human-readable PDF format, ensuring continuity for users accustomed to the previous system.

Additionally, they introduce a new machine-readable format based on the Fast Healthcare Interoperability Resources (FHIR) data exchange standard.

This digital structure enables seamless integration into automated processing systems, aligning with broader initiatives to modernize regulatory data handling in the pharmaceutical sector.

What’s next

Currently, the web-based eAF is available only for variation applications for medicinal products for human use. Other application types, such as marketing authorization applications (MAAs) and renewals, must still use the interactive PDF forms.

However, this will change and the EMA plans to roll out the web-based eAF across all procedures, including MAAs, veterinary variations, and renewal applications.

Following the model used for CAPs, the EMA is expected to recommend broader use for non-CAPs by Q3 or Q4 of 2025. This recommendation would mark a significant step toward broader adoption.

What to expect in 2025

Throughout the remainder of 2025, the platform will continue evolving, with updates that include:

• New functionality based on user feedback and regulatory needs
• Performance and system enhancements
• Redesigned user experience (UX) for easier navigation and interaction

Importantly, no formal date has been set for the mandatory use of the web-based eAF for variation applications for medicinal products for human use. The transition will only occur once feature parity is achieved with the existing PDF version, ensuring full reliability and functionality.

In the meantime, the PDF eAF remains valid and supported. The latest version, eAF v1.27.0.1, was released on 1 May 2025, and its use is mandatory for all new human variation procedures. Remember: the same version must be used consistently throughout a procedure.

Jordan Boyle is Associate Manager, Regulatory Affairs at G&L Scientific.