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

Digitalizzazione farmaci

The European Medicine Agency (EMA) has been working on the digitalisation of regulatory processes for medicines for some time now, also for the purpose to facilitate the exchange of information between Regulatory Authority and the Industry, thus supporting the Regulatory Authority’s output, i.e. the issuing of medicinal product marketing authorisations.

eAF and PMS are the two EMA key projects, interconnected one with the other, for the implementation of this more digital management.

Through the eAF (web-based Electronic Application Form) project, often referred to by its former name DADI (Digital Application Dataset Integration), the EMA is working at replacing current electronic application forms with a fully web-based format, i.e. created inside a dedicated web portal.

The new portal, called Product Lifecycle Management (PLM) Portal, is operational by controlled access as of 4 November 2022.

New data format on Medicines

Through the PMS (Product Management Services) project, part of the SPOR Programme, the EMA is working at the new database of medicines registered in the EU with a new data format for the unique identification of each medicine, starting from the initial submission of the marketing authorisation application and for the following updating activities (e.g. variations and renewals) performed during the entire product life-cycle.

The PSM medicine data is in the ISO IDMP format and can be used across different systems and procedures thanks to their interoperability and high quality.

The new format will replace the current product data format, the extended EudraVigilance Product Report Message (XEVPRM), increasing the granularity of the information, i.e. the level of detail provided.

As they are interconnected, the eAF and PMS projects proceed in parallel. In fact the eAF uses PMS data and, in future, it will be possible to populate PMS using the new portal.

Currently, the data of Centrally Authorised Medicinal Products (CAPs) are already available in PMS, whereas the data of Nationally Authorised Medicinal Products (NAP), including National Procedures (NP), Mutual Recognition Procedures (MRP) and Decentralised Procedures (DCP) should be included in the PMS during the Q2 2023, and available for use in the new eAF.

This is also why new eAF modules are released by EMA one at a time until they cover all regulatory procedures (including new MAs and Renewals) for all human and veterinary medicines.

EMA roadmap

As of November 2022, with the new PLM portal go-live, the first version of the eAF is available for optional (i.e. not compulsory) use by the Industry. This first version is limited to the submission of MA variations for human CAPs.

According to the current EMA roadmap, the second version of eAF will be released between Q2 and Q3 2023.

This version will support all types of EU variations procedures for human medicines, covering both CAPs and NAPs (including MRPs/DCPs). The mandatory use of the new AF format might be expected between Q4 2023 and Q1 2024, with a 6-month transition period during which the use of the old and new eAF is allowed.

What should we expect in the future?

What should we expect in the future? During the first half of 2023, EMA should share more specific time windows on the release of the eAF.

The development team’s priority is now to address post-go live issues of the web form and ensure its stability and reliability. eAF users shall expect continuous improvements and amendments, with new features issued by EMA on a regular basis.

Stay tuned for further news from the Di Renzo Team!

Written by: Monica Chiari