EU Variation Regulatory Reform – Creating Innovation in the Life-cycle Management

Description: The EU variation Regulation has been updated in March 2024 with an implementation in 2025. For a more operational vision, the Detailed guideline for classification of variations dated from 2008 (last update 2013) is under revision. Nevertheless, this is only the first step, limited by the current legislation, and a second step is awaited after the new EU general pharmaceutical regulation is in force (2027-2028).

The current European Commission updates simplify the requirements and procedures, modernise the framework, adapt the rules for grouping and work-sharing, adapt the classification for some products, reduce cost and administrative burden, and implement a risk-based approach. All these propositions align with Regulatory stakeholders’ proposals for the Variations revision.

This session will present an overview of the new changes in the management of post approval changes, including a comparison of the previous and proposed classifications with statistics and impact in the daily work of both regulators and industries in term of volumes of variations being generated.
Panellists from EU Health Authorities and industry will discuss the new rules provided in the new regulation and provide some case studies. This panel session will explore the proposed reforms, implementation aspects and will also discuss further opportunities to be considered ahead of the planned second revision to continue increasing efficiencies for both regulators and industry.