Clean Industrial Deal

In 2019, the European Commission launched the Green Deal initiative, with a strong focus on climate action, zero pollution, chemicals regulation, and the circular economy. As part of this initiative, the Chemicals Strategy for Sustainability – Towards a Toxic-Free Environment (CSS) was published in October 2020. This strategy laid the groundwork for the most significant overhaul of EU chemicals legislation to date, outlining over 80 policy actions.

The pharmaceutical sector is significantly affected by the legislative proposals stemming from the Green Deal. Notably, some of these proposals now incorporate medicinal products within their regulatory scope for the first time. At the same time, EMA has developed guidance and for a to support the implementation of innovation and implementation of alternative sustainable approaches. As a result, the policy and regulatory landscape governing medicines research, development, and manufacturing in the EU is becoming increasingly complex to navigate. Industry stakeholders have further highlighted that in some cases, unintended consequences are emerging, threatening the continuity of pharmaceutical R&D and manufacturing operations.

By 2025, the Commission's attention has shifted toward a "Clean Industrial Deal," aiming to balance environmental priorities with the imperative to maintain a competitive and attractive industrial base in Europe.

This session will shed light on the evolving legislative environment, using specific case studies to illustrate key impacts and opportunities for innovation. It will explore and outline regulatory tools to support sustainability efforts, change management opportunities, and offer practical tools and strategic approaches to help navigate the transition toward more sustainability in manufacturing. science-based legislation—legislation that supports pharmaceutical innovation and manufacturing in Europe while safeguarding patient access to medicines.