Unlocking efficiency through reliance: Navigating the EMA post-authorization framework

This joint webinar, organised in partnership between the EMA and the industry, aims to provide a platform for discussion and awareness on current and future EMA post-authorization framework, including variations and renewals. This event builds up on last year’s session: “Regulatory Reliance Tools Unveiled – A Practical Guide by EMA.”

This year, we will further explore how EMA assessment outputs can support regulatory reliance pathways, helping to streamline the approval of variations (CMC, clinical/safety) efficiently and sustainably.

Spearheaded by EMA, with the participation of WHO and global regulators, the webinar will:

• Explain EMA’s variations and renewals process.
• Describe the purpose and content of assessment document outputs and their relevance for regulatory reliance.
• Address participant questions to enhance understanding and application of these tools.