AmCham EU is committed to the development of a regulatory environment which furthers the capabilities of European healthcare, improving accessibility and ensuring a crisis-resistant medicines regulatory system. We took the opportunity to outline our perspective at the outset of this evaluation and revision process of the general pharmaceutical legislation.
Important aspects which require attention include:
You can read our full response now, which is available below.
The Medical Devices and In Vitro Diagnostics Regulations (MDR/IVDR) have created unworkable complexity for the medical devices industry, with dire consequences for European patients. To address these challenges, Members of the European Parliament (MEPs) or political groups can help address the unintended consequences of the current framework by tabling a Parliamentary Question that urges the European Commission to introduce targeted relief measures in parallel to a comprehensive revision of the MDR and IVDR. This would support the European Commission to implement short-term relief measures, in addition to the MDR/IVDR revision, that bolster efficiency, mitigate administrative bottlenecks and increase predictability in the regulatory processes. This would have an immediate impact on patient access and boost Europe’s innovation.
The proposed Critical Medicines Act (CMA) offers a pivotal opportunity to strengthen the EU’s pharmaceutical resilience. By embracing global supply chain diversification, open trade and strategic international cooperation, the EU can reinforce access to essential medicines while preserving its competitiveness. However, to succeed, the CMA must steer clear of protectionist approaches that risk undermining the internal market and disrupting supply. Instead, it should promote pragmatic, market-driven solutions with strong industry involvement. Read our full position to explore how the EU can foster a stable, secure and innovation-friendly environment for medicines.
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