The European Medicines Agency (EMA) has announced that, as of 1 September 2026, the use of the PLM web-based electronic Application Form (eAF) will become mandatory for all Centrally Authorised Products (CAPs). This milestone marks a significant step forward in the digitalisation of regulatory submissions, following a steady increase in adoption since its recommendation in July 2024.
The transition to the PLM web-based eAF is designed to enhance the efficiency, accuracy, and consistency of regulatory processes. By enabling automated data processing and seamless integration with other EMA systems, the web-based solution supports a more streamlined submission and review process. In contrast, the interactive PDF version of the eAF is more prone to technical issues, may lead to submission rejections, and lacks the same level of system interoperability.
To ensure a smooth transition ahead of the mandatory deadline, companies are encouraged to take proactive steps. These include verifying the integrity of their Product Management Service (PMS) data, ensuring that all relevant users have the correct roles and access rights within the PLM Portal, becoming familiar with the web-based eAF functionalities, and actively practicing submission creation within the system.
From a Data Management and Lifecycle Management (LCM) perspective, particular attention should also be given to the quality and structure of product data. Companies should ensure that product data has been correctly migrated from xEVMPD and SIAMED to PMS, and that product groupings (medicinal products) are properly structured. In addition, reviewing PMS data is critical to avoid issues or potential invalidation during eAF creation, as well as confirming that appropriate user roles (e.g. administrators and contributors) are in place to support efficient eAF management.
From 1 September 2026 onwards, any human CAP variation submissions submitted using the interactive PDF eAF will be rejected unless a valid and justified technical reason prevents the use of the PLM web-based version.
In this evolving regulatory landscape, Asphalion is well-positioned to support organisations in adapting to these changes. With extensive expertise in regulatory affairs and digital submission processes, Asphalion offers tailored guidance, training, and hands-on support to facilitate the transition to the PLM web-based eAF, ensuring compliance while optimising operational efficiency.
If you require support in preparing for these changes, feel free to contact our team at [email protected]
