EMA welcomes the publication of the European Commission’s (EC) new Variations Guidelines, which streamline the lifecycle management of medicines (see EC news). These guidelines will support the implementation of the new Variations Regulation that came into force in January 2025.

The new EC Variations Guidelines, which were developed with support from EMA and the European medicines regulatory network, will facilitate quicker and more efficient processing of variations benefiting both marketing authorisation holders and regulatory authorities.

The new variations framework is part of the overall efforts to improve the efficiency of the European Union (EU) regulatory framework for human medicines, including medicines used in combination with medical devices, with the goal of ensuring optimal and faster delivery of medicines throughout their lifecycle to patients in the EU. It also responds to the increasing number of variation submissions driven by scientific and technological…