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EU RA procedures go digital: the new application form format (eAF) and the new product data format (PMS) – update July 2023

Digitalizzazione farmaci

The European Medicine Agency (EMA) is working on the digitalisation of regulatory processes for medicines with the aim of facilitating the exchange of information between the Authority and the Industry, supporting the Regulatory Authority’s output, i.e. the evaluation and decision-making on medicinal product marketing authorisations.

The electronic Application Form web-based (eAF web-based) and the Product Management Services (PMS) are EMA interconnected key projects. Both are to implement a greater digital processes management of regulatory procedures.

Through the eAF web-based project, often referred to by its former name DADI, the EMA is working at replacing the current electronic application form (eAF PDF) with a new, totally web-based form.

The new web-based form is created in an online dedicated portal named Product Lifecycle Management Portal (PLM). Following the creation into PLM, it will be possible to download the form in XML (FHIR xml) and PDF format.

New data format on Medicines

The PLM Portal is live since 4th November 2022 for the creation of the Human Variation eAF web-based. Currently, the use of the new eAF is optional for the Industry and it is limited to human variations of Centrally authorised medicines. In the future, with a gradual release approach, the PLM portal will also host the eAFs for MA Application and Renewal procedures of all medicines, including those nationally authorised (NPs, MRPs and DCPs) for human and veterinary use.

Through the PMS (Product Management Services), part of the “SPOR” programme, the EMA is delivering a new database of medicines registered in the EU.

The Product data and the relevant documents will be stored in it and will be made available to be re-used in further regulatory activities across different systems and procedures thanks to their interoperability.

For example, the PMS data on medicines will be available through the PLM Portal to support the new eAF. For this reason, the new eAF and PMS projects run in parallel.

At the beginning, the data of NAPs products, including NPs, MRPs and DCPs, should be migrated from EMA internal databases and xEVMPD to the PMS. In this way, the NAPs data, will became gradually available on the PLM portal for their use (optional) use in the new eAF web-based by the Industry.

The release of medicines data in the PMS will trigger the transition towards the mandatory use of the eAF web-based, to cover all regulatory procedures for all human and veterinary medicines.

EMA roadmap

According to the latest EMA roadmap, the release of NAPs in the PMS available to use in the eAF, is expected between November 2023 and February 2024. Consequently, human variation web-based eAF could be optionally used by the Industry starting from same timeline.

For CAPs, the release of split CAPs is expected in October 2023, as an enhancement to their use in the eAF.

In September 2023, the eAF EMA Team should provide further updates based on latest testing outcomes, confirming the above timeline.

Anyway, the current interactive PDF eAF will remain available until the end of the transition period.

What should we expect in the future?

EMA is continuing development work with the aim of incrementally building the new web-based eAF, leveraging on Product Management Service (PMS) data. The key priority for the Agency is to ensure that the eAF is supported by a stable system with high-quality data before starting any transition to the its mandatory use by the Industries.

We should also expect new additional services that will be added to the PLM Portal available to the Industries. For example, the interface to provide data for the electronic Product Information (ePI) and to generate ePI for regulatory procedures, in real time.

Stay tuned for further news from the Di Renzo Team!

Written by: Monica Chiari on 21/07/2023