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 advances in medicine development.
The guidelines will apply to variation applications submitted by marketing authorisation holders to EMA from 15 January 2026. Marketing authorisation holders should consult the new EC guidelines and ensure they are prepared for the changes.
To assist marketing authorisation holders with the implementation of the new Variation Guidelines, EMA will publish updated and new procedural guidance by the end of December 2025.
The guidance will outline important information for companies including:
Regulatory and procedural information on managing variations under the new classification system; andHow to make appropriate use of additional regulatory tools, such as the post-approval change management protocol (PACMP) and the product lifecycle management document (PLCM).More on variations
Medicine developers are required to take account of technical and scientific progress and continuously update the terms of their marketing authorisation to reflect the current understanding of the quality, safety and efficacy of a medicine. To modify any aspect of its marketing authorisation, a company must submit a variation application to EMA for that change and where applicable wait for its approval.
Variations are classified on a risk-based approach as Type IA (minor changes with minimal impact, such as company change of address or product name), Type IB (minor changes requiring notification, such as agreed safety updates), or Type II (major changes, such as a new indication).
The EU medicines regulatory system ensures that all post-approval changes maintain the positive benefit-risk balance of approved medicines, while enabling necessary updates throughout a product’s lifecycle.
The changes are part of the EU’s broader pharmaceutical strategy and represent an intermediate step towards a more comprehensive pharmaceutical legislation reform.